21 CFR Part 11 Compliance Services

PSC Clinical analyzes each sponsor’s compliance needs for 21 CFR Part 11 regulations. In a well-developed process, PSC offers a unique turn-key program including:

  • An inventory evaluation for all GxP systems and associated software applications
  • Gap analysis to identify compliance deficiencies related to use and control of computerized systems
  • Risk assessments of computerized systems to assist in the prioritization of the corrective and preventive actions to ensure Part 11 compliance
  • A remedial action plan documenting planned corrective and preventive actions
  • Resources to implement the remedial action plan
  • Project management to monitor progress against the agreed upon action plan

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