OEE Systems

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://www.its-ltd.co.uk/services/oee-systems-5.aspx

Introduced in the 1960s and 70s for the Japanese Automotive Industry, Overall Equipment Effectiveness (OEE) is a key metric used by many manufacturing industries today, to improve line and overall plant efficiency.

OEE calculations are based on three main criteria: performance, availability and quality. The results from OEE calculations determine Productivity Analyticshow effectively production machinery  and equipment is running. In an ideal world a machine would run 100% of the time producing 100% good quality products. However studies show that the average OEE rate in manufacturing plants is 60%.

In order to improve OEE, a range of data needs to be collected including equipment, machine, production efficiency, waste, downtime, operators, orders, shifts, events, products, causes, frequency and reasons.

Productivity Analytics

Industrial Technology Systems Ltd (ITS) provides OEE Systems, designed to automatically collect this real-time data for further analysis. Whilst an OEE System alone will not increase productivity, the accurate real-time equipment and plant metric data collected and stored in the automated system, enables companies to make effective, quick decisions that improve overall efficiency and profitability.

ITS offers ICONICS Productivity Analytics OEE solution. The system empowers decision makers at all levels of the enterprise with real-time and accurate information to help them drive global operational efficiency and strengthen competitive market advantage. Gain insight into your operations through real-time data aggregation and connectivity to multiple data sources, presented in an intuitive and intelligent manner. Productivity Analytics helps to establish manufacturing context with KPIs such as OEE, cycle time and throughput, and deliver manufacturing intelligence to the entire organisation.

 

Traceability Systems

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://www.its-ltd.co.uk/services/traceability-systems-4.aspx

Manufacturers in safety critical industries such as aerospace, automotive, food and beverage, medical device, nuclear and pharmaceutical are responsible for tracking and tracing products through all stages of production, processing and distribution. Real-time computerised traceability systems offer an effective, accurate and reliable solution to meet these requirements.

ITS can offer advice in traceability solutions, including the food regulation 178/2002/EC, introduced in January 2005, RFID, DPMI (the process of marking products with a 1D or 2D code to track the parts) and Machine Vision Systems. Whether you need assistance in identifying your needs, writing a User Requirement Specification or designing and implementing a solution, ITS’ team can assist.

Since Industrial Technology Systems (ITS) was established in 1991, the company has designed and implemented many traceability systems in regulated industries. ITS’ traceability systems are designed to track products through all stages of the manufacturing cycle. The systems gather real-time shop floor data through the automatic devices (code readers / RFID), provide full audit trails and accurate genealogy, required to meet strict industry regulations.

 

Serialisation Solutions

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://www.its-ltd.co.uk/services/serialisation-solutions-102.aspx

In an effort to eliminate the lucrative counterfeit medicine market and increase consumer safety, global regulations introduced to increase the traceability of prescription drugs outline the requirement for pharmaceutical companies to introduce unique identifiers on the smallest saleable units of prescription drug products.

Specifically, companies will be required to generate a unique serial number and include it alongside other product data on the drug packaging. The exact data that needs to be contained within the data matrix codes and in a human readable format varies with each country’s interpretation of the traceability initiative. Serialisation and reporting are a minimum requirement, with additional requirements for tracking drug product through the supply chain, and the ability to verify individual product at any point in the supply chain.

The scope of the different legislation is just one of the challenges that companies face trying to implement serialisation solutions. The deadlines of November 2017 (US) and February 2019 (EU) are approaching quickly and companies that are not compliant by this deadline will be unable to sell their products in these respective markets.

Implementing a robust serialisation solution should be a prerogative for pharmaceutical manufacturers, and that is where ITS can help. From requirements gathering and the creation of User Requirement Specifications through to implementation and validation, you will be in the hands of a knowledgeable company and an organisation that enjoys a wealth of experience in the pharmaceutical industry.

Established in 1991, ITS has nearly 25 years of experience in implementing fully validated solutions in highly regulated industries. Companies, pharmaceutical or otherwise, can benefit from ITS’ services, including:

  • Creating User Requirement Specifications (URS) – outlining your serialisation requirements at an early stage will help to avoid expensive corrective measures later on in the process. With ITS’ extensive experience in developing detailed User Requirement Specifications, we can ensure that your needs are captured fully going forward.
  • Serialisation solutions – being independent, you can be sure that ITS will design and implement a turnkey serialisation solution that is tailored to your company’s specific needs.
  • Validation – Implementing new technology within a pharmaceutical manufacturing environment will require validation. ITS can offer fully validated solutions, or offer validation services for companies that have already implemented a serialisation system.
  • Service Level Agreements (SLA) – Once your serialisation solution is implemented, ITS can offer an SLA to support and maintain the solution.

Supported by a wealth of testimonials, ITS has extensive experience in the design, implementation and validation of solutions for many pharmaceutical manufacturing customers. You can be confident that, by choosing us for your serialisation solution needs, you will also benefit from this experience.

With the deadline looming, ITS’ services and solutions will ease the stress of the transition for serialisation compliance for your business.

 

Fusion Reporting Tool

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE:http://www.its-ltd.co.uk/services/fusion-reporting-tool-47.aspx

47

 

Industrial Technology Systems Ltd (ITS) has developed FUSION, a zero footprint, web-based reporting and data entry tool with an optional back-office calculation engine for producing process accounting data. The award-winning product, based on an AspenTech InfoPlus.21 or other database, was designed in 2000 for companies with locked down desktops and is ideal for regulated industries.

FUSION provides a single repository for all operational data. Its flexible and simple browser enables users to configure screens easily and efficiently, and to identify faults quickly. When integrated with an AspenTech InfoPlus.21 or other database, FUSION enables users to manage weekly, monthly and yearly (periodic) operating reports, process loss accounting, batch information etc. Users can interrogate the data in the reports and using the context linked FUSION toolbox, see how values are derived by drilling down through the calculation chain to the root of the data.

FUSION has been designed to work over web-based technologies. The core configuration is maintained on a server, and viewing/data entry is via web clients – this means there is only a single maintenance arena and low ownership cost.

Product Features

  • Calculation Engine
    – Developed using InfoPlus.21 SQL stored procedures
  • InfoPlus.21 or Other Database
    – Stores the source and calculated data
  • SQL Server
    – Stores the screen configuration
  • Intranet Website
    – Provides access to the reports via menu structure HTML
  • Intranet Application
    – Builds screens from SQL Server and retrieves the data using VB

Benefits

  • Robust and proven system
  • Uses readily available and maintainable technology
  • Simple system
    – No duplication of data
    – Single repository for all operational data
    – Flexible easy to configure screens
  • Automated data collection and reports
    – More consistent data
    – Minimum data entry
  • Ease of Use
    – Browser interface is familiar to most engineers
    – The user-friendly client-side functions enables data to be entered easily and ‘obvious’ faults identified quickly
  • Ease of Development
    – With the bulk load tool a change can be specified in a file, then loaded into a test system for proving
    – Once proven the bulk load file can be sent to the live system
    –  Bulk load allows rapid duplication and reworking of a configuration item and the creation of templates
  • Ease of Deployment

ITS was awarded the Solution Innovation Award for its FUSION product at the AspenTech Global Sales Kickoff Meeting in Florida. AspenTech President and Chief Executive Officer made the presentation at the meeting, held in the opulent surroundings of the Omni Orlando Resort at ChampionsGate, Orlando.

 

MES Systems

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://www.its-ltd.co.uk/services/mes-systems-2.aspx

Manufacturing Execution Systems (MES) bridge the gap between the management team and the shop floor operations. The systems provide real-time data to control manufacturing processes more effectively. Manufacturing Execution Systems gather data from the sales/ordering process, provide instructions to the operators and equipment, and communicate the production status, material consumption, quality control and maintenance data back to the management team.

With this real-time data, companies can monitor plant conditions and respond quickly to drive increases in productivity, improvements in product quality, machine utilisation and reductions in costs. This information allows management teams to examine business areas, identify areas for improvement and solutions to resolve any problems.

With ITS’ extensive experience in Manufacturing Execution System solutions, our team can offer services to support customers throughout the lifecycle of an MES project. Whether you need assistance in identifying your requirements, writing a User Requirement Specification (URS), or meeting regulatory demands, ITS’ team can offer the level of support needed.

Several manufacturers sell their products in a modular fashion. ITS’ experts understand how these applications fit together and can help you to select the right modules to achieve the greatest benefit. Our MES team also provides ongoing support for Manufacturing Execution System solutions.

ITS is an approved systems integrator for the main MES suppliers including AspenTech, GE Fanuc, Rockwell, Siemens, Werum Software & Systems and Wonderware (Invensys). As an independent company we can implement the solutions that are best suited to meet each customer’s needs.

ITS’ expertise in Manufacturing Execution Systems is evident through our position as the first solution provider to implement both Wonderware’s InTrack MES and Tecnomatix’s Xfactory system in the UK. Our team has experience in the following systems.

AspenTech InfoPlus.21 (IP.21) ICONICS BizViz
• Citect AMPLA • Rockwell RS PMX MES
• Wonderware ArchestrA

 

Management Information Systems

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://www.its-ltd.co.uk/services/management-information-systems-3.aspx

A Management Information System can hold a complete model of an entire factory’s performance. Recipes, schedules, equipment effectiveness, fault classes, stock levels, run times, equipment availability, productivity levels, alarm statuses – as you can see there is no shortage of facts. But how can you make sure that the data collection is simple, accurate, relevant and timely? You can rely on Industrial Technology Systems Ltd’s (ITS) engineering and the technology available, bound by your business Key Performance Indicators (KPIs) and objectives.

With this real knowledge at your fingertips you can use the information to speed fault finding processes and to aid sound business decisions. ITS’ engineers will work closely with you to understand your requirements and present the information in a suitable, meaningful and comparative fashion so that trends are clear and discrepancies are obvious. A variety of formats can be used to present the data including graphs, contour plots, mimic diagrams and histograms, and the data can be presented on different machines, lines, shifts or products.

With a Management Information System making knowledge and insight available to management personnel, most companies see real business benefits.

ITS offers expertise in the design and integration of the following Management Information Systems:

AspenTech InfoPlus.21 • Oracle
• Citect Ampla • OSIsoft PI
ICONICS BizViz • Rockwell RS PMX MES
ICONICS Hyper Historian • Wonderware ArchestrA
ICONICS Productivity Analytics • Wonderware InSQL
• Microsoft SQL • Wonderware Downtime Analyst

 

 

Electronic Batch Record Systems

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

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.

 

Controlled-Release Drug Delivery Technology Market: Global Industry Analysis and Opportunity Assessment 2017-2027

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://www.futuremarketinsights.com/reports/controlled-release-drug-delivery-technology-market

Specific focus on the quality-by-design (QbD) approaches for the robust design of dosage forms is expected to change the future landscape of controlled-release drug delivery technologies.  While conventional hydrophilic matrix based technologies such as Accuform are being used in the market for several years, recent advancements in the development of oral drug delivery systems such as gastro-retentive drug delivery for controlled release, buoyant systems, mucoadhesive systems for regulated release of anti-viral medications etc. would increase the penetration of controlled-release drug delivery technologies in the global pharmaceuticals market. Acuform polymer-based patented technology is widely being used in a number of controlled-release formulations such as NUCYNTA ER, Gralise (Depomed Inc.), Janumet XR (Merck), Glumetza (Salix Pharmaceuticals) etc. Wurster coating technology is being used in the drug coating for controlled release of drug since 1976. Corplex transdermal technology has largely been commercialized in P&G’s Crest product line. Plenty of new controlled-release technologies are in phase to be commercialized in next few years. For instance, MicroCor PTH using MicroCor transdermal technology is being evaluated in phase IIa.  OROS technology which delivers drug in controlled manneris being used in more than 17 commercially available drugs. In case of oral controlled drug delivery, elderly persons and pediatrics constitute the large proportion of consumers for controlled-release drugs due to increase adherence to dosage regime. Some of the commercially available medications using controlled-release drug delivery technology include Prozac (polymer matrix based system), Avinza (polymer coating), Capoten (enzyme activated system), GLUCOPHAGE XR (polymer matrix based system), Alza (osmotically activated system) etc.

Controlled-Release Drug Delivery Technology Market: Drivers and Restraints

The global market for controlled-release drug delivery technology is driven by increasing the need for pediatric controlled release dosage forms, high acceptance of CR dosage forms due to once-a-daily dosing nature, etc. However, some of the major factors restraining the global market for controlled-release drug delivery technology are fewer excipients are deemed acceptable for pediatric use, the requirement of a high dose of API, promising development of CR dosage forms that impart abuse resistance, a higher price of controlled-release systems compared with traditional pharmaceutical formulations, etc. Moreover, some of the biopharmaceutical challenges for development of controlled-release drug delivery systems such as establishing desired release profiles for new chemical entities, risk management of dose dumping, selection of biocompatible and biodegradable materials with desired controlled-release properties, etc.

Controlled-Release Drug Delivery Technology Market: Segmentation

The global controlled-release drug delivery technology market has been segmented on the basis of technology, release mechanism, application, and geography.

Based on technology, the global controlled-release drug delivery technology market is divided into following:

  • Wurster technique (drug coating)
  • Coacervation
  • Micro Encapsulation
  • Implants
  • Transdermal
  • Targeted Delivery
  • Microelectromechanical Technology
  • Others (Liposomes)

Based on release mechanism, the global controlled-release drug delivery technology market is divided into following:

  • Polymer Coating Systems
  • Polymer Matrix Based Systems
    • Hydrophilic Polymer Matrix Systems
    • Lipophilic Polymer Matrix Systems
  • Micro Reservoir Partition Controlled Drug Delivery Systems
  • Feedback Regulated Drug Delivery Systems
  • Activation-modulated Drug Delivery Systems
    • Mechanically Activated
      • Osmotic Pressure Activated
      • Hydrodynamic Pressure Activate
      • Vapor Pressure Activated
      • Mechanically Activated
      • Magnetically Activated
    • Chemically Activated
      • pH Activated
      • Hydrolysis Activated
      • Enzyme Activated

Based on application, the global controlled-release drug delivery technology market is segmented as below:

  • Metered Dose Inhalers
  • Injectable
  • Transdermal and Ocular Patches
  • Infusion Pumps
  • Oral Controlled-drug delivery Systems
  • Drug Eluting Stents
  • Others

Controlled-Release Drug Delivery Technology Market: Overview

The global market for controlled drug delivery technology is expected to gain traction during the forecast period due to increasing commercialization of new technologies by a number of modified release products launches. Loss of patents for some of the controlled-release drug delivery technologies would present an opportunity for generic players to penetrate the market. For instance, blockbuster osmotic delivery system OROS would be off patented by July 2017 and the technology will lose the pediatric exclusivity by January 2018. Allergan Plc. received FDA approval for Generic Cardizem extended release tablets indicated for the treatment of hypertension.

Controlled-Release Drug Delivery Technology Market: Regional Wise Outlook

Geographically, the global controlled-release drug delivery technology market is classified into regions viz. North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific, Japan, Middle East and Africa. North America will continue to hold the largest share in the global controlled-release drug delivery technology market due to rising number of NDA and ANDA applications being filed by the key players. Europe is expected to hold second largest share in the global market for controlled-release drug delivery technology market. However, APAC is expected to witness highest growth rate due to expansion activities by the key players in the region.

Controlled-Release Drug Delivery Technology Market: Key Players

Some of the market players in the global controlled-release drug delivery technology market are Depomed, Inc., Coating Place, Inc., Corium International Inc., Alza Corporation (Johnson & Johnson), Pfizer Inc., SKY Pharmaceuticals Pvt. Ltd. and others. Global pharmaceutical companies are desperately looking for new strategies to increase profitability and in line with this number of companies are bringing in the market, the modified release formulations of existing drugs due to short pathway for approval while maintaining their market share.

The report covers exhaustive analysis on:

  • Market Segments
  • Market Dynamics
  • Market Size
  • Supply & Demand
  • Current Trends/Issues/Challenges
  • Competition & Companies involved
  • Technology
  • Value Chain

Regional analysis includes

  • North America (U.S., Canada)
  • Latin America (Mexico, Brazil)
  • Western Europe (Germany, Italy, U.K, Spain, France, Nordic countries, BENELUX)
  • Eastern Europe (Russia, Poland, Rest Of Eastern Europe)
  • Asia Pacific Excluding Japan (China, India, ASEAN, Australia & New Zealand)
  • Japan
  • The Middle East and Africa (GCC, S. Africa, N. Africa, Rest Of MEA)

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 in the industry
  • In-depth market segmentation
  • Historical, current, and projected market size in terms of volume and value
  • Recent industry trends and developments
  • Competitive landscape
  • Strategies of key players and products offered
  • Potential and niche segments, geographical regions exhibiting promising growth
  • A neutral perspective on market performance
  • Must-have information for market players to sustain and enhance their market footprint

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

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

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

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

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.

 

 

Modeling

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.

Standards



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.