GMP Audits: Moving from an Adversarial to a Cooperative Process Whitepaper

FDA regulated industries require audits to establish both compliance and performance, which go hand in hand. GMP audits demonstrate that products, services, and quality systems are reliable and safe. In turn, the level of quality performance serves as the basis for compliance.

As well as being a part of compliance and regulatory requirements, audit management is essential for assessing and improving the success of processes, products and systems. They verify objective evidence of processes functionality, and providing evidence for the reduction and elimination of any problem areas.

Traditionally, regulatory audits have a negative connotation which tends to create an adversarial atmosphere between the outside auditor and the company being audited. However, the process can be much more collaborative with the right approach. This white paper explores:

  • Regulatory guidance and standards
  • Common reasons audits fail
  • 7 ways to improve audit outcomes and make audits more productive for you and your auditor