Pharmaceutical Electronic Batch Records (EBR) Software
CGMP software helps automate and standardize processes to get to market faster. GMP quality systems connect and ensure quality throughout the product life cycle. Information is maintained in a central location. Compliance is simple.
Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system.
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.
The cGMP regulations describe requirements to be followed by pharmaceutical manufacturers, applicants, and the FDA. The regulations ensure products are safe for use and have the ingredients and strength they claim to have. The FDA enforces multiple GMP quality-related regulations. These include 21 CFR Parts 210-211, which relate to GMP compliance for drug products.
The cGMP regulations are in place to ensure product quality and consumer safety. CGMP compliance requires that manufacturers sufficiently control their manufacturing operations. This includes establishing a strong QMS and robust operating procedures. Manufacturers can determine the best methods of implementing controls.
The cGMP guidelines are minimum requirements. They allow some flexibility for manufacturers. This flexibility lets companies use modern GMP quality systems and approaches to improve quality through continuous improvement.