Every phase of research and development, manufacturing and quality control, and product distribution must be thoroughly documented and reviewed at every phase.
Maintenance of these records is vital to the day-to-day operation of every pharmaceutical company manufacturing and marketing drugs and is necessary for establishing a detailed audit trail for every lot of product manufactured.
Pharmaceutical companies have traditionally used paper to maintain batch records also known as Master Production Control Records (MPCR). Many companies have realized that the burden of paperwork can be lessened with the use of EBR Software.
Accountability is an important component of quality management and FDA compliance for Pharmaceutical companies. Electronic Batch Recording Software enhances transparency, productivity, control, and 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.
Benefits come with Electronic Batch Recording Software:
- Reduce time, cost, and effort
- Bring end-to-end transparency
- Enhance accuracy and consistency of batch records
- Speed up product changes and new product introduction
- Speed up information distribution and collaboration
- Help to identify loopholes, mistakes, and errors
- Reducing the no. of lost batches
- Minimize reworks and investigation
- Access trending, productivity and metrics instantly
- Reduce warehouse inventories
This transition from paper-based batch records to electronic batch records can be challenging. Employee pushback, system validation, and incomplete and inadequate identification of requirements can put your systems and processes at a higher risk of failure.