EO Control Systems Gamma Control Systems Sterilization
 
 

Electronic Signatures

21 CFR Part 11 compliant electronic signatures are applied to various documents including:
  • Receipts
  • Specification Approval Process
  • Shipping
  • Certificates of Processing

konnTRACK Signed Specifications Report

Konnexis software solutions include regulations and policies which are fully compliant with recordkeeping requirements of the FDA statute. Some requirements implemented are:

  • Validation – systems must be validated as per the requirements of 21 CFR Part 20 and per General Principles of Software Validation; Final Guidance for Industry and FDA Staff
  • Availability – records must be available for review or audit
  • Retention – records must be available for the retention period dictated by the product being processed
  • Audit Trail – system must proved a secure and independently generated audit trail of any actions that create, modify or delete records.
  • Sequence – system must ensure proper steps are followed
  • Authority Checks – privilege based security ensures operator has appropriate privileges to perform a specific function

21 CFR Part 11 compliant report

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