Quality Systems & Records

Biotech and Pharmaceutical Quality Systems & Records

BioPharma Consulting Group’s (BCG) Quality Systems and Records support is essential to biopharmaceutical manufacturing. We provide a comprehensive overview of quality records such as deviations, investigations, corrective/preventive actions and change controls initiated for analytical development, routine, and stability testing.

An all-inclusive quality system (e.g. Trackwise, Veeva) and thorough completeness of quality records ensure that each batch is released to the highest standards. Thorough handling of quality records provides assurance to leadership and regulatory agencies that the company is in full control of their processes and demonstrates the business’s ability to drive compliance.

Quality records must be initiated and completed with all due diligence and accuracy while following current Good Manufacturing Practice (cGMP) guidelines. They must be fully comprehensive to provide clear evidence of adherence to quality standards and regulations. This includes suitable record keeping of all testing and inspection activities, as well as any changes or modifications made to any validated process or procedure. It is also important that these records are stored securely to ensure they retain their integrity and remain accessible during audits and inspections.

BioPharma Consulting Group provides a comprehensive framework for establishing and maintaining quality systems and records throughout the entire production process. Combined with rigorous oversight and proactive risk management strategies, BCG ensures the safety and efficacy of drug products.

Contact us to discuss how BCG can assist your business in maintaining its quality systems and records within the highest possible standards.