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The software validation guidelines and standards provide specific recommendations and requirements for validating software used in regulated industries, ensuring that the software meets quality, safety, and compliance standards. Organizations developing or using software in these sectors should be aware of and adhere to the relevant guidelines that apply to their specific use cases.

Check out the following list of relevant industry guidelines and standards related to software validation, particularly in regulated industries such as pharmaceuticals, medical devices, and healthcare:

  • GAMP (Good Automated Manufacturing Practice):
    • GAMP 5: Provides a structured approach to computer system validation and is widely used in pharmaceutical and biotechnology industries.
  • FDA Software Validation Guidelines:
    • FDA Guidance for Industry – Computerized Systems Used in Clinical Investigations: Offers guidance on computerized systems used in clinical trials.
    • FDA Guidance for Industry – Part 11, Electronic Records; Electronic Signatures (21 CFR Part 11): Focuses on the use of electronic records and electronic signatures in regulated industries.
  • ISO 13485 (Medical Devices – Quality Management Systems):
    • ISO 13485 includes requirements related to the validation of software used in medical devices.
  • ISO 62304 (Medical Device Software – Software Life Cycle Processes):
    • Specific to the software development life cycle for medical device software.
  • ISO 14971 (Medical Devices – Application of Risk Management to Medical Devices):
    • Emphasizes risk management, which is integral to software validation in the medical device industry.
  • IEC 62366-1 (Medical Devices – Part 1: Application of Usability Engineering to Medical Devices):
    • Addresses the usability engineering of medical device software.
  • IEC 62304-1 (Medical Devices – Part 1: General Requirements for Basic Safety and Essential Performance):
    • Provides general requirements for medical device software.
  • EU Medical Device Regulations (MDR and IVDR):
    • These regulations include requirements for the validation of software used in medical devices.
  • FDA General Principles of Software Validation (FDA Guideline for Off-The-Shelf Software):
    • Focuses on the validation of off-the-shelf software used in medical devices.
  • EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulation):
    • These regulations include specific requirements for the validation of software used in medical devices.
  • NIST SP 800-53 (Security and Privacy Controls for Federal Information Systems and Organizations):
    • Provides security controls for federal information systems and can be relevant to software validation in government and healthcare sectors.
  • EU Annex 11 (Computerized Systems) to GMP Guidelines:
    • Offers guidelines on the use of computerized systems in the pharmaceutical industry.
  • ASQ SWGDAM Guidelines (Scientific Working Group on Digital Evidence):
    • Focuses on digital evidence in forensic science, including the validation of software tools.
  • ASQ IT Audit Guidelines (American Society for Quality):
    • Provides guidelines for auditing information technology, including software validation.