Our Skill Sets

Please see the dropdown menu for additional information on specific services we provide.   The following list includes some of the guidance documents that apply in the life science industries and with which we have experience.

General GMPs:

• 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
• 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
• 21 CFR Part 820, Quality System Regulation
• ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories

Computer Systems

• 21 CFR Part 11, Electronic Records and Signatures
• EU Annex 11, Computerized Systems
• GAMP 5 Guide, Validation of Automated Systems
• FDA Final Guidance for Industry, General Principles of Software Validation
• FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application
• ANSI/AAMI/IEC 62304:2006, Medical device software – Software life cycle processes (2006)
• IEC/TR 80002-1, Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
• UCM085371, FDA Guidance on Software Validation (2002)

Medical Devices

• UCM089593A, FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (2005)
• UCM073779, FDA Guidance on Off-The-Shelf Software Use in Medical Devices (1999)
• UCM356190, FDA Premarket Submissions for Management of Cybersecurity in Medical Devices
• ANSI/AAMI/IEC 62304, Medical Device Software – Software Life Cycle Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• CLSI AUTO11-A, IT Security of In Vitro Diagnostic Instruments and Software Systems
• Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufactures of In Vitro Diagnostic Devices
• De Novo Classification Process (Evaluation of Automatic Class III Designation) Draft Guidance for Industry and Food and Drug Administration Staff
• Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff
• 21 CFR 809, In Vitro Diagnostic Products for Human Use
• ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
• ISO 14644, Cleanrooms and associated controlled environments
  • ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
  • ISO 14644-2, Cleanrooms and associated controlled environments — Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
  • ISO 14644-4, Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
  • ISO 14644-5, Cleanrooms and associated controlled environments — Part 5: Operations
  • ISO 14644-7, Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
  • ISO 14644-8, Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness by chemical concentration (ACC)
    ISO 14971:2012, Medical devices – Application of risk management to medical devices
• ISO 14971, Medical devices — Application of risk management to medical devices
• ISO 18385:2016, Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements

Other

• ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
• ISO 31000, Risk management — Principles and guidelines
• ISO/IEC 31010, Risk management — Risk assessment techniques