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21 CFR Part 11

Assessment, Validation, Compliance! Consider it done!
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As per the FDA regulation, by 2014 all the clinical data captured during drug manufacturing process will have to be stored in electronic format. In coming years all the drug manufactures and laboratories will have to comply with 21 CFR Part 11 standards.

We help you comply as we have
  • Extensive knowledge of 21 CFR Part 11 and its clauses
  • Experts who know the nitty-gritties of electronic records and signatures
  • Expert software and hardware teams who can build solutions for you
 

Operational benefits
  • Secured data transfer and recording using digital signatures (FDA regulation: Section: 11.50)
  • Data security and user authentication (Section: 11.70, 11.100(a),(b),(c))
  • Traceability (add, modify, delete) for all the captured data with user / device details (Section: 11.10 (e))
  • Longer data retention period, easy backup and data retrieval (Section: 11.10 (c))
  • Unique identity for each data logging device (Section: 11.10 (h))
  • System implementation as per GLP and GAMP and other FDA regulatory clauses
 

Our solutions ensure
  • Existing investments are safeguarded, ensuring seamless compliance with minimal changes to existing systems
    • Add-ons that connect to existing devices like data loggers, PID controllers, PLCs, production / lab equipment and other type of devices
    • Software plug-ins / libraries that communicate with existing SCADA or DCS applications
  • Quick and cost effective compliance
  • Better and secured data management policies
  • Minimal infrastructure changes
 

A methodical process ensuring 100% 21 CRF Part 11 compliance
  • Conduct gap analysis for compliance
  • Identify impact on existing system and suggest optimal way to meet compliance using
    • Hardware add-ons
    • Software plug-ins
  • Establish user identity, user accountability and procedures
  • Role based access, dual authentication and digital signature
  • Help you acquire / revoke / manage digital certificates
  • Setup password policies and implement biometric systems wherever required
  • Validate the system against a 53 point checklist
  • Define Part 11 process based on individual organization needs
  • Design audit trails and retention mechanism
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