How electronic batch recording software encounter the challenges of pharmaceutical industry?

As a Pharmaceutical company, your proof of success is found in the document records that you keep. Documentation is your proof that your product and services are produced in compliance with cGMP regulations and your company’s operating procedure and standards. That’s why it’s said that any Pharmaceutical organization is producing two things drugs and paper.

Hence developing paper free environment is in demand. According to FDA’s cGMP (Current Good Manufacturing Practices) Electronic Batch Recording Software demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.

Complexities associated in manually managing the batch records:

  • Slow, cumbersome and error prone
  • Taking more time to prepare and review
  • Incorrect data entry
  • Failure to recognize out-of-specification entries
  • Missing signatures
  • Filling out incorrect forms
  • Sending forms to the wrong recipient
  • Forms left incomplete
  • Increase instance of lost batches

In today’s cut-throat competitive world, success depend on just in time (JIT)delivery and these above mentioned complexities are creating obstacles to achieve JIT. Hence Pharmaceutical industry have realized the importance of having a dynamic Electronic Batch Recording Software.

Web based Electronic Batch Recording Software is an easy to deploy solution for mid and small size Pharma manufacturers because of quick hassle free implementation and the low cost of ownership. Electronic Batch Recording Software (EBR) capabilities:

  • On-screen access to current batch record
  • Step control with step-based work instructions
  • Qualification checks on all equipment and materials used
  • Automated data capture from equipment and devices
  • Real-time limit checking
  • Automated calculations
  • Forced authentication
  • Forced sequencing
  • Electronic signatures
  • Data review dashboard for “review by exception”
  • Compliance flags indicating non-conforming data values
  • Audit trails with operator identification and date/time stamp
  • Trending reports and batch certificates
  • Export data to external systems such as MES and ERP

How Electronic Batch Recording Software help manufacturing operators and managers as well as QA data reviewers:

  • Standardize and efficient document flow
  • Centrally and readily retrievable documents
  • Save time with right first time data collection
  • Minimize reworks and investigations
  • Reduce overall cycle times to release products
  • Reduce warehouse inventories
  • Maintain consistency with use of most current version of Batch Records throughout organization