How eBR systems help to ensure Right first time

Quality should be “built into” the product. It means that during product manufacturing, it is better to take measurable actions to ensure performing an operation correctly, rather than working on it again to correct mistakes.

Production rework is always something that might be necessary in manufacturing operations, but if it happens quite frequently, it could not only hurt the bottom line but also point to a problem with systemic inefficiencies.

When we talk about the Batch Record,there are several areas which may contribute to rework in operations:

1. Production reworks:
correcting defective products to make them acceptable.

- Unclear process sequence in the record. This may trigger wrong production process and operation resulting in defective product
- An operation was skipped because there was insufficient oversight of the paper record’s production process.
- Poor management of parameters that are outside of specifications, especially for important processes
- Human mistakes during production including manual computation/calculation

2. Batch record reworks:
correcting the record due to missing or incomplete required GMP information which prolongs the review process

- Legibility issue: Due to natural flaws in handwriting, corrections are frequently necessary to clarify.
- Attributable issue: A problem with who did what and when as paper records may not contain necessary information.
- Contemporaneous issue: Sometimes the operator forgets or doesn’t have time to fill in the record at the time, delaying until the end of a production process, which may also trigger an accuracy issue due to reliance on memory.

All of the above issues are inevitable on paper-based operations, it’s simply because of inherent risks of a manual paper-based process, over which there is little control. All the aforementioned issues, especially those relating to data integrity, can be resolved by putting in place an eBR system.

Blocks and checks can be set up using computerized systems to make sure that no data elements necessary to build the electronic batch record are missing. In doing so, it is also possible to sequence and lock data entry so that data items are only present and available for input at the time of generation, rather than entered retrospectively, assuring the desired integrity of the data.

The usage of electronic batch records also enables Right First Time by providing quicker feedback, for instance in the case of input errors or exceptions. The ability for many parties to act and interact with the batch record simultaneously also ensures better collaboration, more accurate data, and, as a result deliver higher product quality and efficiency.