The U.S. Food and Drug Administration's (FDA) Current Good Manufacturing Practices (CGMPs) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability. Paper-based systems are cumbersome and error-prone. The right electronic batch record (EBR) software system removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.
CGMPs require extensive EBR systems documentation. This includes the following:
• Batch dates.
• Identity of major equipment/lines used.
• Components/materials used and their weights and measures.
• In-process and laboratory control results.
• Complete labeling control records.
• Identification of personnel supervising or checking each step.
Pharmaceutical companies have traditionally used paper (hard copy) to maintain production batch records. With the advent of 21 CFR Part 11 in 1997, the FDA began to accept EBR systems. When you adopt an EBR system, it must be in compliance with regulations found in 21 CFR Parts 210-211. The requirements include a time-stamped audit trail, reporting, electronic signature and security requirements.
EBR software prevents mistakes from slowing the entire production process.Download the Product Data Sheet