Regulatory Compliance

AgiLab’s platform is fully compliant and suitable to meet regulatory requirements, such as:

  • FDA 21 CFR part 11, including electronic signatures and auditing
  • Good Laboratory Practice (GLP)
  • European Medicine Agency (EMEA) guidelines
  • Good Manufacturing Practice (GMP) including Annex 11 and Annex 15
  • GMP specific to Advanced Therapy Medicinal Products
  • GAMP 5 (ISPE) Guidelines: Compliant GxP Computerized Systems
  • ISO 17025, ISO 9001
  • ISO/IEC 27001:2013

ISO 27001

AgiLab is operating a mature company-wide quality management system for ISO 9001 (general) and ISO 15504 (Software Development Process) and maintains a comprehensive security program based on ISO 27001 to ensure the confidentiality, integrity, and availability of customer data. ISO 27001 is a globally recognized security standard that provides a guideline of the policies and controls that an organization has in place to secure their data.

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