MasterControl CAPA Software - Managing Corrective / Preventive Actions for Medical Device and Pharmaceutical Manufacturers

For medical device companies, CAPA requirements are stipulated in 21 CFR Part 820.100. For pharmaceuticals, they can be found in 21 CFR Part 211. ISO-adherent companies must also comply with CAPA requirements (ISO 9001:2000 Clause 8.5.2 and Clause 8.5.3). Without a well-functioning CAPA system, FDA inspectors will continue to focus on this area of compliance.

The MasterControl CAPA Tech Paper will help you understand:

• The key elements of a CAPA process.
• The major challenges in an enterprise wide CAPA implementation.
• How MasterControl can solve these challenges to ensure compliance.

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