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21 CFR Part 11 Compliance Audit 
& Gap Analysis Assessments

Audit, and Assessment of your computer systems and software, is essential for 21 CFR Part 11 and Validation readiness:

  • 21 CFR Part 11 Electronic Records; Electronic Signatures

  • ALCOA++ Data integrity

  • EMA Annex 11 Computerized Systems

  • ISO 27001 Security Systems

  • GAMP 5 - Good Automation Manufacturing Practice 

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At GMP We Know the Regulations:

  • GMP Audits the Federal Regulations

  • GMP Prints the Federal Regulations

  • We Assist Help Companies in Complying!

At The Validation Group:

  • Provide the Validation Templates

  • Provide the SMEs for your Software

  • Write, Execute and Manage Validations

Full Validation and Qualification services:

Supporting Pharmaceutical, Medical Device, Biologics and Laboratory Equipment, Software and Systems, Cosmetics, Dietary Supplements, and Regulated Industries. Support Validation Activities required by ISO Compliance.

Full Gantt driven task management.

  • Validation Services – Development of Validation Protocols – Contract Developer

  • Equipment Validation and Risk Assessments

  • Process Validation Services

  • Facilities Commissioning and Qualifications – Basis of Designs

  • Software and Systems Qualifications - 21 CFR Part 11 Compliance and Gap Analysis

  • Analytical Methods and Laboratory Software and Systems Qualifications

  • Cleaning Validation 

  • Distribution and Logistics

  • Validation Standards, Procedures and Practices supporting:

    • Validation Master Plan Development

    • Project Plan Development;

    • User requirements;

    • Functional requirements;

    • Matrix Development;

    • Design qualifications (DQ)

    • I/O Verifications and Qualifications

    • Integration Qualifications

    • Bespoke Applications

    • COTS Applications

    • SaaS Applications

    • Installation qualifications (IQ)

    • Operational qualifications (OQ)

    • Performance qualifications (PQ)

  • Supporting, but not limited to:

    • Databases – Robust and Non-Robust

    • Quality Management Systems (QMS)

    • Maintenance, Calibration & Engineering Management Software

    • Laboratory Information Management Systems – Equipment Software

    • Document Management Software and Systems

    • Inventory Management Software - Enterprise resource planning (ERP) Software

    • Financial and Business Software

    • SaaS, IaaS, PaaS, Systems and 3rd Party Software Products

    • Spreadsheets – Microsoft Excel, Microsoft Lists, Google Lists,

    • EMAIL and Text Messaging Software Systems

    • PLCs, SCADA, and DCS Software Systems

    • AI Automated Manufacturing Systems

    • GAMP 5 Required Systems

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