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

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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