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Software for Validated and Compliant Systems

If a system is being developed for a regulated area the software must be designed and written to follow a set of recognised standards. We at Aitken Scientific have a detailed quality system which follows the ISPE GAMP standard, and have many years of experience putting it into practice with approvals for some of the major pharmaceutical companies.

Do any of the following apply to you?

  • A need for a validated software package
  • 21 CFR Part 11 compliance - more information...
  • Carefully written and well structured documentation
  • Comprehensive test plans
  • A pragmatic approach - we adopt a sensible, efficient and cost effective approach to all documentation
  • Calibration of equipment - pipettes, GC and HPLC, Tensile testing machines