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21 CFR 11 compliance

FDA 21 CFR Part 11 Compliance

SEAMetal HD (version 5.1 and up) supports the technical requirements for the FDA’s 21 CFR Part 11 regulatory codes.

These codes govern and outline the use of data security and integrity for critical data. The system puts into place not only regulatory requirements governing how e-signatures, audit trail, encryption and authentication – but also rules and regulations for training, procedural and operator/administrator accountability.

Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) allows FDA regulated companies to take full advantage of electronic technology while ensuring their implemented systems are aligned with the FDA’s responsibility to protect public health.

SEAMetal HD helps support the FDA 21 CFR part 11 requirements by providing the following capabilities:

  • Validation
  • Accuracy
  • Protection
  • Security/Encryption
  • e-signatures – Cryptographic hashing
  • Authenticity
  • Audit trails
  • Accountability
  • Physical token
  • Linking for relational databases
  • Timestamping
  • Redundancy of data
  • Tamper detection
  • Tamper protection
  • Archival protection and support
  • Administrative approvals
  • Post measurement comments

These capabilities empower users who would like these capabilities, even outside the US where these requirements are not critical. In such cases, the system provides an added security protection layer to the system.

Features supporting the 21 CFR part 11 codes are provided as a standard, at no additional cost, to all full version SEAMetal HD (5.1 and above) customers as of Jan 1, 2008.

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