Electronic Batch Record Systems


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SOURCE: http://www.its-ltd.co.uk/services/electronic-batch-record-systems-64.aspx

ITS offers 21 CFR part 11 compliant Electronic Batch Record Systems, designed to replace manual data capture processes in processing, food and beverage, and pharmaceutical production plants.

Paper-based systems are often used in regulated industries to manually record all the actions performed by operators and support staff during the creation of products batches and each record is signed accordingly. These paper-based systems are difficult to administer/enforce and extremely time consuming to verify during batch approval and release processes.

Manufacturers are recognising the importance of Electronic Batch Record Systems in increasing productivity, reducing time to market and improving FDA regulatory compliance. ITS specialises in designing and implementing web-based EBRS systems, developed using standard Microsoft products, and hosted on web servers. Access is provided through Internet browsers on standard Windows’ workstations, and wireless hand-held data capture devices with integral barcode scanners are used to record the data. The systems are fully compliant with 21 CFR Part 11, the FDA’s rule for electronic records and signatures.

ITS’ Electronic Batch Record Systems automatically create/control electronic forms to record any of the following activities.

  • Work order creation
  • Component dispensing
  • Line clearance
  • Component collection
  • Production
  • Production interventions
  • Production output
  • Product quality sampling to ISO2859 requirements
  • End of batch checks
  • Return to stock
  • Waste calculations
  • Product handover and packing

The main business drivers for EBRS automated systems are:

  • Ease of record creation by the client
  • The systems enforce process control
  • 21 CFR Part 11 compliance

The automated capture of component movement and consumption throughout the manufacturing process, is consolidated into the batch record, listing all inputs into the manufacturing process, all movements of material through the workflow and all products generated, accounting for any waste/losses and items returned to stock. This provides the client with comprehensive mass balance reconciliation.

The batch report also lists all corrections entered during the product batch. Together these enable the customer to perform the batch approval and release process in a fraction of the time required by the original manual verification and checking of all manual entries. This provides a huge reduction in the elapsed time between the creation of product and its approved release, which provides significant savings in the cost of work in progress with a corresponding reduction in the time from order placement to the product being available for delivery to the customer.

Access to ITS’ Electronic Batch Record Systems is restricted to authorised users and enforced through a combination of username, password, group membership and permission-based access controls.

All data entry is tagged with the user’s identity and time stamped accordingly. The facility to correct user entries is provided for the relevant data items, but this requires the user to enter a change reason which is stored in a time-stamped record with the new and previous data values, and the user’s identity as per the requirements of 21 CFR Part 11.

Similarly, any direct changes to the underlying database are recorded automatically by a secure third party package to provide a full audit trail of what was changed, when and by whom.


Electronic Batch Records Market: Global Industry Analysis and Opportunity Assessment 2016-2026


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SOURCE: http://www.futuremarketinsights.com/reports/electronic-batch-records-market

The introduction of Electronic batch records will optimize the work by reducing the production life cycles, improve accuracy and consistency. Electronic batch record is a compilation of information, data and document into a single record. It provides history of the batch, quality information, operator interactions etc. Automation of batch records can also bring down the cost as it offers paperless solutions by replacing paper batch records and also keeping track of the automated batch history is easier through the online environment. Manual maintained of records can impact the whole production quality and slight changes in production sequence can even detent product from quarantine till the review was completed. Since only one copy or master copy of manual records exist coordination between different departments become difficult. The advantages offered by Electronic batch records are manifold like automated calculations, electronic signatures, save time, online access, easier audit trails etc.

Generally pharmaceutical companies prefer in using Electronic batch records (EBR) but now many of the industries started using the electronic batch records as it reduce cost, risk and possibility of human errors.

Market drivers & challenges:

Many industries are planning to shift to automation thereby reducing the overall human resource cost which is a major driver for the market. The need to improve workflow and efficiency of industries was also a major driver for electronic batch records market. With the evolution of information technology and adoption of ERPs along with EBR was also a major driver for electronic batch records market. Challenges of electronic batch record market are fraud detection and need for adequate testing to be done before implementing. Compliance with established government standards and regulations is another major challenge.  Another major challenge was handling multiple manufacturing styles as every industry has own characteristic data models.

Market Segmentation:

Global electronic batch records market is classified into end-user and region. On the basis of the end user, the global electronics batch record market is segmented into pharmaceuticals, Life sciences, automobile and others.

On basis of region global electronics batch records market is segmented into North America, Latin America, Eastern Europe, Western Europe, Asia Pacific Excluding Japan (APEJ), Japan and the Middle East and Africa (MEA).

Key Market Players:

The major players active in electronic batch records market are Rockwell Automation, Honeywell international, Emerson Electric Co, ABB, Schneider Electric SE, Siemens AG, Accelyrs, SAP SE, etc.

The report covers exhaustive analysis on:

  • Global Electronic Batch Records market segments
  • Global Electronic Batch Records market dynamics
  • Historical Actual Market Size, 2014 – 2015
  • Global Electronic Batch Records market size & forecast 2016 to 2026
  • Ecosystem analysis
  • Global Electronic Batch Records market current trends/issues/challenges
  • Competition & Companies involved technology
  • Value Chain
  • Global Electronic Batch Records market drivers and restraints


The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Report Highlights:

  • Detailed overview of parent market
  • Changing market dynamics of the industry
  • In-depth market segmentation
  • Historical, current and projected market size in terms of value
  • Recent industry trends and developments
  • Competitive landscape
  • Strategies of key players and product offerings
  • Potential and niche segments/regions exhibiting promising growth
  • A neutral perspective towards market performance
  • Must-have information for market players to sustain and enhance their market footprint.

Electronic Batch Record System


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SOURCE: http://www.pharmacim.fr/Electronic-Batch-Record-System.html

Time decrease for batch liberation
According to the master sheet, PHARMACIM® DLE software centralyses data collected during the manufacturing process of the medicine. The electronic batch record system collects and gives information for control and validation from the launching of the manufacturing order to the end of the inspection storage year.




PHARMACIM® BPM has a process parameterizing graphic tool for an easy customization.
Accessible to users without any computing competences, the graphic creation allows a modeling of all manufacturing unit processes.
Each step of the process is built with elements that can have access to information system components of the production unit :

  • M.E.S. (Manufacturing Execution System)
  • L.I.M.S. (Laboratory Information Management System)
  • E.R.P. (Enterprise Resource Planning)
  • Monitoring systems
  • automated systems
  • Supervisors


Data adquisition and collection

PHARMACIM® enables you to recover all the information coming from miscellaneous applications (MES, ERP…) or manufacturing systems (automation, measuring instruments…).
Strengthened by a 30-year-old expertise in pharmaceutical production systems, COURBON, has the required skills to implement material and software solutions so as to collect data. Our teams have already set up :

  • interfaces with ERP systems : SAP/R3, Protean, Qualiac, MS Dynamics, Prodig, Minos, …
  • applications with industrial systems : Siemens, Rockwell, Emerson, Schneider, Intellution,…

Implementation and monitoring

Pharmacim® pilotes all processes, from the launching of the manufacturing order to the final validation and recording.
For each step of a process, the software collects, distributes, exchanges and storages data with other information system components.
Pharmacim® has all required tools to control the whole process and/or a specific step of a process.

Dynamic Piloting

Through a dynamic screen, each user has, a real time list of the operations for which an action is expected for the process continuation.
The user has also an access to the documentation without waiting for its final constitution.

Optimisation of validation channels
If the process is stopped too much time, PHARMACIM is able to orientate the action to an other user

Variation management

Every critical step generates a real time analysis of its managed data, and a variation management with respect to the target. The software creates warnings and pilotes dedicated validation channels.

Marking & serialization

Facing notably counterfeiting, laboratories are asked by authorities to take measures.
Manufacturers have to implement traceability systems with the aim to enable product certification in easiest and quickest conditions possible. The aim is to ensure full traceability of products to dispensaries.


Several norms will soon be effective such as :

  • in 2009 : the Turkish regulation imposes a serialization, Datamatric identification and a full filiation,
  • in 2011 : the French regulation imposes a Datamatrix identification according to ISO/CEI 16022 norms and EAN.UCC 128 syntaxis,
  • in 2011 : the Californian regulation imposes a serialization, Datamatrix identification and a full filiation,
  • in 2012 : the Canadian regulation impozes a Datamatrix identification.












Electronic Batch Record System (EBR)


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SOURCE: https://software.rescop.com/electronic-batch-records/

Objective of the Electronic Batch Record System (RC-EBR)

Time and costs as well as errors and deviations can be reduced with the Electronic Batch Record System. Manual systems can be replaced by an Electronic Batch Record System to maintain your batch records in an automatic and controlled manner.

The Rescop Electronic Batch Record System stores, manages, processes and publishes batch record documentation, in accordance with GMP regulations.

Main functionalities of the Electronic Batch Record System (RC-EBR)

  • Creation and maintenance of document content and generation of .pdf versions
  • Content creation by either uploading of documents with common file types or based on templates, forms and protocols
  • Storage, review and approval of documentation
  • Publish and search for documentation
  • Configure document (sub)types and corresponding execution, verification, review and approval workflows
  • Configurable roles and rights
  • User interface depending on roles and rights
  • Version Management
  • Schedule, trigger and register manufacturing execution
  • Possibility to print authentic copies
  • Management Reporting

Benefits of the Electronic Batch Record System (RC-EBR)

The batch record handling is GMP compliant. The Rescop Electronic Batch Record System provides a standardized and efficient document workflow and documentation is centrally and readily retrievable.
The manual system can be replaced by paperless manufacturing execution and compliance. The Rescop Electronic Batch Record System works on personal computers, laptops, tablets and smart phones.
Electronic Batch Record System

Electronic Batch Record System workflow


Electronic Batch Records: Best Practices for Implementation and Validation | IVT


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Electronic batch record systems (EBR) are increasingly commonplace in pharmaceutical and biotechnology manufacturing environments. EBR systems are used for the automation of the execution of a batch record; they can be interfaced with many different types of systems, equipment, and instruments. Control of the batch record use when manufacturing pharmaceutical and biotechnology products is a regulated process of critical importance to assure product quality and patient safety. Therefore, the implementation strategy, validation, and on-going control of EBR is of utmost significance and interest to regulatory authorities when they perform inspections of manufacturing facilities. This paper discusses current topics, considerations, and controls necessary for the implementation and validation of EBR.


Improvements and innovation in manufacturing execution systems through technological breakthroughs in system design have been critical to the development of systems that automate complex regulated processes in the industry. Automation of complex regulated processes provides efficiency, cost reduction, and increased compliance. EBR systems represent one example of these technological improvements, and they are capable of a high degree of integration with different types of systems and equipment, including both manufacturing automation equipment (e.g., distributed control system, programmable logic controllers) and business systems, such as enterprise resource planning systems. EBR systems provide critical functionality that help ensure a high-level of efficiency, consistency, and reproducibility. Because of these factors and the increased quality provided by EBR systems for pharmaceutical and biotechnology products, their use within these types of manufacturing environments is increasing.

Implementation Challenges

During the implementation of EBR systems, project teams face many challenges that can have a negative impact on business and compliance. Some of these challenges are related to the attempts to automate an inefficient and cumbersome manual batch record process. A lack of understanding of the technology capabilities, limitations, and constraints of the batch record process may create unrealistic expectations by the system owner. Many times, EBR project teams lack the knowledge and understanding of the applicable regulatory requirements found in Code of Federal Regulations (CFR) Title 21 Part 11, 211.186, 211.188, and 211.192. These regulatory requirements are critical to implementation of EBR, and they need to be clearly understood to avoid compliance issues and unnecessary cost. The applicable regulations cannot be ignored or misinterpreted by the project team. These regulations need to be seen as critical user requirements that can be implemented by the technical team. Implementation best practices will be discussed later in this paper.

Validation Challenges

One of the main challenges for the validation team is having adequate time in the project schedule to test critical requirements that can have a negative impact on product safety and quality. It can be quite challenging if the technical team is also responsible for validation because they may lack the regulatory knowledge and understanding of the critical aspects of the system. Inadequate knowledge of the critical aspects may lead to the validation team excluding items that are critical to the manufacturing process and decisions made by the EBR system from the validation functions and calculations. These challenges can be avoided by having a solid validation strategy that is based on the results of risk assessments that were performed to identify and mitigate high-risk requirements. Qualified resources are needed as part of a project team, which must have both a solid technical and validation understanding of the applicable regulatory requirements. Validation best practices will be discussed later in this paper.

Implementation Best Practices

When implementing EBR systems, one of the major challenges is attempting to automate an inefficient and cumbersome manual process. Another challenge is managing the resistance from the users and system owners with regards to changing their current paper process before moving batch records to an electronic format. These challenges can have a negative impact on the implementation and expected return of investment (ROI) of the technology. It is strongly recommended that companies invest their time in redesigning their paper batch record to eliminate inefficiencies and unnecessary steps in the process that will add cost to the EBR implementation. Process-mapping activities should be performed to identify and eliminate waste prior to the EBR implementation. An assessment of the applicable regulatory requirements should be performed to ensure that all steps implemented in the redesigned process are compliant with regulatory expectations. Companies should avoid implementing requirements that exceed regulatory expectations because this could lead to an inefficient and expensive implementation that will have a negative impact on the ROI. Electronic record requirements related to data integrity, security, and user access are critical to the EBR implementation and validation. Electronic signature and audit trail requirements are critical, and they need to be addressed in the user requirement specification and verified during validation.

The following implementation best practices should be considered during the implementation of EBR systems in the pharmaceutical and biotechnology industry:

  • Process-map current process
  • Redesign paper process to eliminate waste and inefficiencies
  • Perform assessment of applicable regulatory requirements and their impact to the process (21 CFR Part 11, 211.186, 211.188, 211.192)
  • Identify key requirements based on the process redesign and assessment of applicable regulations
  • Translate applicable regulatory expectations into user requirements.

The success of the implementation depends on assurance that inefficiencies and waste are eliminated before automating the batch record process. An accurate understanding of the regulatory requirements is needed to reduce the compliance and business risk.

Validation Best Practices

Validating EBR systems can be very challenging; it requires a solid validation strategy that is based on the results of functional risk assessments. These risk assessments are intended to identify and mitigate high-risk requirements that can have negative impacts on the system and product quality. Prior to the risk assessment being performed, the project team needs to identify and document critical user requirements. An assessment of the regulatory requirements applicable to batch records needs to be performed in order to identify critical requirements that must be implemented in the EBR system. The strategy needs to be documented in a validation plan. The validation plan should provide the following information:

  • Purpose
  • Scope
  • System Description
  • Roles and Responsibilities
  • Applicable Standard Operating Procedures
  • Risk Management
  • Validation Deliverables
  • Validation Strategy
  • Acceptance Criteria
  • References.

Process-mapping and redesigning the current process provides input to the user requirements needed to implement the EBR system. Additional requirements will be identified as a result of comparing the assessment against the applicable regulatory requirements. Assessing the regulatory requirements found in 211.186, 211.188, and 211.192 helps to identify the requirements related to quality approvals of the batch record, when the identification of individuals is needed and the information is needed in the batch record. It is critical that all the regulatory expectations are translated accurately in the user requirements. Incorrect interpretations of the regulatory requirements can lead to increased compliance risk and implementation of inefficient controls that can have a negative impact on the batch record cycle times.

One of the biggest challenges during the implementation of EBR systems is understanding what is critical and any impact to the batch record process. Technical teams lack the understanding of the process and normally tend to downplay the impact on critical functions such as calculations. This creates a major challenge when the technical team is given the authority to determine the critical aspects of the system. Based on the author’s previous experience, technical teams will underemphasize the criticality of functions in order to reduce the validation effort and deliver the project according the schedule. It is very important that decisions about system critical functions and calculations include the system owner and users of the system. The system owner is the subject matter expert of the process and the most qualified member of the team to determine criticality. Decisions related to criticality should not be influenced by reducing the validation effort; they should be based on functional or requirement risk assessments. These risk assessments should assess the potential failure scenarios of the critical functions, including calculations that are used by the EBR system to make critical decisions about the batch. The entire batch records process workflow needs to be validated during performance qualification to ensure that all controls, required signatures, and approvals have been implemented. Performance qualification should include validation of the entire batch record process; including all functions, calculations, and approvals; to ensure that it meets user requirements. The bottom line is that an EBR system is high-risk; it has direct impact on the product, and a significant amount of its functions include calculations that are critical to the process and should be validated.

For an EBR implementation, the following validation deliverables should be considered:

  • System Assessments
    • GXP
    • Part 11 Applicability
    • System Risk Assessment
    • Direct/Indirect Assessment.
  • Validation Plan
  • User Requirements
  • Functional Specifications
  • Design Specifications
  • Configuration Specifications
  • Risk Assessments
  • Validation Protocols
  • Validation Summary Reports
  • System Security and Access Controls.

System Operation and Maintenance

Once the validation is completed, the EBR system changes need to be managed under change control. Changes to functions, requirements, and design require a change control that is assessed by the appropriate SMEs, including the system owner and user groups. Changes to critical calculations should be managed under a change control or procedure that controls the lifecycle of formulas and calculations. Verifications or validation for changes to calculations should include verification that data is being pulled from the correct database locations. This should also include verification that calculated values are accurate and reported to the appropriate number of decimal places. This verification can be performed using test scripts or a protocol.

In addition to controlling changes to the system during the operational phase, procedures need to be established for backup and restore, incident and problem management, disaster recovery, periodic reviews, system security, and user access.


In summary, the considerations for validation of an EBR system are similar to any other computer system used in the industry. However, it is important to understand the process, critical aspects of the system, and the applicable regulatory requirements that will be automated with the EBR system. All of these critical aspects require a solid validation strategy that is based on the results of risk assessments that identify critical functions and calculations of the system. Downplaying the complexity, regulatory requirements, and risk can lead to an implementation that may increase compliance risk. The system complexity and the fact that the process is highly regulated require a significant amount of inspection readiness.

Ivan Soto

GMP Standard Operating Procedures


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Part 1 – GMP Standard Operating Procedures
1.1 – Validation Procedures SOPs
  1.1.1 – Process/Cleaning/Method Validation Procedures
Here you can download samples of the procedures, click on title
This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required. Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.
This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.
This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure. The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks.
This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation.
This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose. This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.
The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies.  It defines the responsibilities within the trial process and documents that need to be considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements. This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment. There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e. concurrent and prospective validation) and qualifications (OQ, PQ).
This SOP defines the procedure for cleaning, passivating and derouging the purified water system at a GMP site. The procedure may be performed after construction, following invasive repair or following maintenance.  The various parts of this procedure are to be performed as necessary.  Parts of this procedure may not always be executed at the same time (e.g., The storage tank for the purified water may be cleaned and passivated without cleaning and passivating the ringmain).
The scope of this procedure includes the validation of 1. Sampling methods used to determine residues after cleaning of manufacturing and packaging equipment used for the production of commercial product. 2. Analytical methods to detect residue after cleaning of manufacturing and packaging equipment used for the production of commercial product.
The objective of this Standard Operating Procedure is to describe the actions required to handle deviations encountered during validation studies.
The Validation Master Plan is designed to provide a planned and systematic framework within which all validation activities will occur.  This document will also ensure that the manufacturing facilities comply with the local applicable GMP regulations and site requirements for validation.
This policy applies to all production process used for manufacture of commercial drug products or in-process materials for commercial drug products. Excluded form this scope is filling of tablets and capsules and labelling and secondary packaging of all drug products.
This validation guideline describes the approach and methods which will be used for the qualification of equipment at a GMP manufacturing site.  The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing requirements for the validation of the equipment that is involved, directly or indirectly, in the manufacturing and testing processes.  The plan pertains to the qualification of processes and laboratory equipment.
The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing required for the validation of the facilities and utilities that are involved, directly or indirectly, in the manufacturing processes at a GMP site.
This procedure is applicable to validation sampling and testing for all new product introductions, and when changes to manufacturing procedures, manufacturing equipment, or raw materials warrant process validation.  Each situation will be assessed on an individual basis, and the appropriate sections of this document shall be applied.
The purpose of this Standard Operating Procedure is to describe the evaluation process for a new, or a change of, source raw material used to manufacture Drug Products at the GMP manufacturing facility. The procedure will provide a documented means of assuring that the changes are identified, documented, authorised and implemented taking due account of quality, regulatory and validation factors as well as environmental and safety issues.
To outline the requirements for preparation, review, approval and execution of process validation protocols and preparation, review and approval of process validation reports for semi solid and solid dose products manufactured at a GMP Manufacturing Site.
The purpose of cleaning validation is to provide documented evidence that the cleaning process is effective in removing residues of a product, cleaning agent or microbial contamination to below a predetermined level. The objective of this guideline is to describe the approach and methods, which will be used to validate cleaning and sanitation procedures involved in GMP processes employed in GMP Site Manufacturing facilities.
The purpose of the VPP is to, 1. Establish a plan for the overall validation effort and validation lifecycle to describe the extent of the validation effort required to meet Site and regulatory requirements. 2. Define Validation Deliverables for the computer system. 3. Provide a standardized format for Validation Project Plans.
This procedure serves as a guideline for the development of a User Requirement Specification (URS) document and Functional Requirement Specification (FRS) document for a computer system at a GMP manufacturing facility.
This SOP is to provide guidelines to ensure that materials that are brought into the manufacturing plant for trial purposes and not recorded into Material database are still accompanied by documentation so that their usage is recorded and reconciled and equipment that they contact is also recorded.
This SOP covers the validated Direct Impact Systems (including the facilities, utilities, equipment, process control systems, computer / automation systems) and Processes in production, storage and distribution of drug products in a GMP site.
The purpose of this SOP is to define common procedures to be followed when organising Trials, including allocation of responsibility to coordinate the Trial and suggestion of what needs to be considered when preparing the Trial documentation.

Electronic Batch Records: A Story of Workflow Improvement


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SOURCE: http://www.automationworld.com/batch-manufacturing/electronic-batch-records-story-workflow-improvement

The story of electronic batch records began as a way to streamline regulatory compliance. Now these records can also help users produce higher-quality batches and ensure optimal workflow.

Once upon a time, electronic batch records (EBRs) were simply a means for helping pharmaceutical companies automate away the mountains of paperwork required for maintaining production batch records. But the story didn’t end there.

Consider, for example, Baxter S.A. The diversified healthcare company is among a growing group of global manufacturers that are also using the technology to develop, implement and even enforce optimal workflows.

This new narrative began to take shape in industry in the ‘90s when the U.S. Food and Drug Administration (FDA) issued new 21 CFR Part 11 compliance standards. The regulation’s promotion of good manufacturing practices (GMPs) permitted production facilities to use EBRs to document each step in the production, packaging and handling of every batch of their products. Since then, automation vendors have shown users how automating batch records can also help them improve their workflows and efficiencies.

A case in point is Baxter’s production facility in Lessines, Belgium, where the company makes intravenously administered nutriments for patients in healthcare facilities. A new automated line there prepares solutions of glucose and amino acids and puts them into storage bags with help from Wonderware software from Schneider Electric. Not only does the software help the line conform to governmental compliance regulations in the U.S. and Europe, but it also helped Baxter double production, streamline operations and manage costs.

“EBRs are traditionally generated by MES [manufacturing execution system] or batch-management applications,” explains Michael Schwarz, product marketing manager for MES, EMI, workflow and batch software at Schneider Electric. Not only do MES and batch-management software help in managing process execution, but they also capture event execution and data records through automated means, by enforcing manual data entry, or both.

“In doing so, these software systems have significantly reduced the manual activities required to capture batch data or generate electronic reports and production documents,” says Schwarz.

At Lessines, these benefits came through Schneider Electric’s Wonderware InBatch software, which oversees batch execution, maintains equipment histories and material genealogies, and generates the necessary reports. Besides complying with the FDA’s 21 CFR Part 11 regulations, the software also conforms to the S88 batch process control standard developed by the International Society of Automation (ISA). In addition, the software relies on the World Batch Forum’s batch markup language standards to create XML (extensible markup language) documents for recipe-version histories and comparisons.

Because InBatch runs on the Wonderware System Platform, it has access to a process historian that archives production histories, compresses data, and auto-configures historical archives. Once configured, the Wonderware Historian and the vendor’s eSignature management applications ensure that the new automated line complies with the FDA’s regulations and adheres to the company’s optimal workflows. The data also gives decision-makers the historical information that they need for continuous-improvement initiatives.

Another outcome of running InBatch on the object-oriented System Platform is that Baxter was able to design a custom set of ISA S88-compliant objects representing such things as valves, sensors, weigh scales and variable-speed drives. Stored in the system’s library, these objects can be maintained from a central location and reused for future projects. Any change to an object can be linked to all instances within the system and applied only to those instances specified by the engineering staff. This ability to apply changes selectively permits the staff to validate modifications before making a global deployment.

Looking beyond the process

Documenting batch production fully, however, often requires actions beyond process automation itself. Examples include tracking quality-conformance data, compiling these records into product certificates, and documenting sign-off procedures.

“Coordinating the timely execution of quality-related activities at the end of a batch, assembling the data for documentation, and getting sign-offsare beyond the scope of the production or quality system domain,” notes Schwarz. “They still rely heavily on human collaboration.”

To oversee these interactions, automation vendors have established links to business-process and workflow-management software. “This helps to coordinate and document the activities and data flows between people and systems used in production, quality, asset management and business domains,” says Schwarz.

Schneider Electric, for example, has integrated Wonderware Skelta BPM workflow software with its Wonderware System Platform to automate human-centric workflows, as well as the processes with links to applications like enterprise resource planning (ERP) systems and SharePoint collaboration tools.

“An end-of-batch event, for example, could automatically present a sequence of quality-related activities as workflow notifications or work tasks, which in turn could initiate the required data flows or sign-off processes,” says Schwarz.

He adds that the software can replace paperwork with electronic work instructions and records even in semi-automated production environments that are still run in an operator-centric fashion. “This enables similar collaboration with quality or business functions as well as the automation of product, quality and document sign-off and approval processes,” he says.

Just by reducing manual activities in these instances, electronic workflow management can expedite the execution of EBR processes, while improving their definitions, documentation and consistency in execution.

Incorporation into ERP

Such uses of EBRs evolved alongside information technology. As capabilities multiplied and costs fell, EBRs moved well beyond the initial practice of simply scanning batch production records and storing them in an electronic repository.

Meanwhile, “as ERP-system adoption became more prevalent, EBR capabilities started to appear in stand-alone systems and in pharma-specific ERP systems,” recounts Reddy Beeram, director of product development at Edgewater Fullscope, an ERP consulting firm and Microsoft Dynamics partner. “A more recent evolution of EBR involves capturing batch production record information at the source and as the batch production progresses, from release to completion.”

Besides automating the collection and documentation of process workflows as they happen, the latest ERP systems have extended EBR capability to MESs and other classes of applications that affect batch records: product lifecycle management (PLM), laboratory information management systems (LIMS), and corrective actions and preventive actions (CAPA) software.

These developments have not been without their problems, however. Neither conventional “administrative” ERP systems nor complex niche MESs were dealing with EBRs in an efficient manner, observes Colin Masson, global industry director for manufacturing at Microsoft Business Solutions. “Many MES architectures are inflexible and don’t scale for multi-site rollouts, which is a must in today’s global, connected industry,” he says. Likewise, administrative ERP systems are not really designed for the demands imposed by the realities of manufacturing and need a fair measure of customization.

“Especially when customized, these traditional ERP and MES architectures could not cope with the constant reconfiguration and requirements to support Lean and Six Sigma initiatives,” adds Masson. They also have difficulty handling multiple manufacturing styles that have their own characteristic data models. “For example, EBRs often need to feed and provide traceability from batches through to discrete manufacturing ‘pill and pack’ operations. This is a challenge for traditional systems.”

Meeting these challenges is usually expensive and requires engineering skills that are in short supply. Because it exceeds the automation threshold that keeps many batch manufacturers from using them, they continue using manual processes based upon paper records.

To overcome the threshold for conventional MES applications and administrative ERP systems, some software vendors are offering what they call “operations ERP.” An example is Microsoft Dynamics AX 2012. “Its architecture is built to support high-fidelity, quality, compliant manufacturing,” says Masson. It is extensible and supports open web services to promote integration with mobile devices and automated data-collection devices.

The power of connectivity

This movement to make EBRs available to ERP systems and other business applications is really a manifestation of a more widespread trend—the trend everywhere toward greater connectivity. In the batch industries, the result is that more users are asking for the ability to access recipe and other information from a variety of places, reports Eric Heavin, advanced solutions and services sales consultant at Yokogawa Corp. of America.

“These users want links to workflows,” Heavin says, “so that, if they receive an order that needs to be filled by a particular day, it is sent to the DCS [distributed control system], scheduled, executed and recorded in an historical database; and results post back to the ERP system.”

Users have a raft of reasons for wanting this ability. One is to transfer data accurately throughout the organization in real time. “There is a lot of potential for error in the manual recording and transfer of data,” notes Heavin. Another reason is traceability. “Some users might keep track of it for liability reasons. They may even have to keep data for a certain number of years for their customers.”

Others simply want the ability to mine the vast amounts of historical data that is now cost-effective to collect and store for long periods of time. An example of this can be seen in a job Yokogawa did recently to help a company in the oil and gas industry improve the tracking of its products after manufacturing.

“Engineers there were trying to track the different grades going to various locations and produce a monthly reconciliation report,” recalls Heavin. “They did it by taking the pertinent data from each historical production or transaction record.”

Through an analysis, they were able to determine where the mislabeling of a product occurred and to reconcile actual product movements and transactions against the inventories in their accounting system.

In this case, the historical records were taken from a structured query language (SQL) database that had been populated over time with data collected automatically from the process. Access to a uniform set of highly granular data makes it possible for the company’s engineers to conduct various kinds of studies. Not only did they have the flexibility to track the movement of products throughout the supply and delivery chains, but they also could look at what a particular tank, for example, was doing on any day in the past.

Although the evolution of information technology has made keeping vast amounts of data for these purposes cheap and practical, Heavin warns users to store only the necessary information to avoid being overwhelmed with superfluous data. “That’s critical for presenting only pertinent data to personnel, so they can make decisions about whether a procedure or formula needs adjusting to generate improvements,” he says.

Batch documentation – Pharmaceutical Manufacturing


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SOURCE: http://www.gmpua.com/World/Manu/15/c.htm

Here you will find answers to the following questions:

  • What must the manufacturing instructions/batch processing record contain?
  • Example: Manufacturing instructions/record
  • What must the packaging instructions/batch packaging record contain?
  • What does the expression “Electronic Batch Recording System” mean?
  • What must a testing procedure contain and how must it be organised?
  • What does a test protocol contain? How must raw data be handled?
  • What is a BRR and what is its purpose?
  • How can the BRR be documented?

All tasks relevant to the manufacturing, packaging and checking of medicinal products can be traced via the batch documentation. This is particularly important if quality problems occur that did not exist or were unknown at the time the medicinal product was approved for sale. In terms of product liability, a properly compiled batch documentation is often the only means at the disposal of the pharmaceutical manufacturer for providing evidence (see chapter 1 Quality Management). This not only underscores the importance of compiling GMP conforming documentation, but also emphasises the necessity for appropriate subsequent handling.

Example of a batch record:






What is 21 CFR Part 11?


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SOURCE: https://www.instantgmp.com/compliance/21-cfr-part-11

What is 21 CFR Part 11?

These days, manufacturers are talking about the FDA’s 21 CFR Part 11 requirements for electronic documentation but what does that mean? This primer will give you an understanding of the FDA’s requirements.

In the 21 CFR Part 11 documentation, the FDA states:

“FDA has concluded that regulations are necessary to establish uniform, enforceable, baseline standards for accepting electronic signatures and records.”

Part 11 regulations cover issues such as:
•Audit trails
•Electronic signatures
•Copies for inspection
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

(d) Limiting system access to authorized individuals.

(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

(k) Use of appropriate controls over systems documentation including:

(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.