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.
Reviewed on Capterra
"The proof really is in front of regulatory agencies such as FDA, Notified Body, TGA, etc where every time I was audited for he functions I managed (Document Control, Training, Change Management, Records Control and HR), I was able to demonstrate controls and compliance over the entire Document, Training and Change Management systems. We've received high remarks from these agencies on system."
Reviewed on Capterra
"Easy to configure and has the ability to customize a lot of features to your companies needs. Time for new users to feel comfortable in the system is pretty minimal considering how complex the system is as a whole."
EBR software prevents mistakes from slowing the entire production process.Download the Product Data Sheet