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.

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

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