CSV Services

Specification for computerized systems (CS)

Manufacturing plants or analytical instruments for quality control, are combined with computerized systems and are software controlled.

Therefore, data integrity, audit trail, authorization, disaster recovery, testing and validation have become key elements to CSV. IT experts need to cooperate with GMP experts and laboratory technicians.

We offer CSV expertise on biopharmaceutical manufacturing, analytical laboratories, and their quality assurance.

Our Expertise

  • Sound knowledge and hands-on experience with analytical instrument qualification, method validation, and process equipment validation
  • Ability to interpret regulations and to apply them to the validation operations according to international regulation authorities
    • GAMP
    • FDA 21 CFR Part 11
    • EU GMP Annex 11
    • EU GMP Annex 15
    • OECD consensus documentation
    • AMG, AMWHV, EU-GMP, MHRA, WHO, FDA

  • Data Integrity ALCOA principles
  • Data Types (e.g. Phyton)

Our Support

  • Preparing validation master plan and validation plans
  • Registration and assessment of computerized systems (CS) and CS-Interfaces
  • Risk Assessment of computerized systems (CS) and CS-Interfaces
  • Setting specifications for computerized systems (CS) and CS-Interfaces
  • Defining and analyzing workflows for computerized systems (CS)
  • Designing risk analysis, test plans and test protocols
  • Design and assessment of user requirement and functional specifications (URS, FS)
  • Preparation of the respective documentation for computerized system validation

Your Benefits:

  • GMP compliant computerized systemsy
  • Supporting quality assurance