FormaliS uses its experience to look for answers to your quality management questions.

Activity:

  • Support, Consultancy and Assistance in┬ádesigning Software Development Life Cycles (SDLC)
  • Support, Consultancy and Assistance in the design of the validation documentation
  • Analysis and/or improvement of existing SDLC and quality systems
  • Design of new or alternative quality systems
  • Introduction of risk-based approach in validation
  • Review of development and validation documents
  • Design of new/alternative documentation systems

Scope:

  • Computer systems in clinical studies
  • Computer systems in lab environment
  • Computer systems in production sites
  • Development of validation plans
  • Execution of software validation programs

Standards:

  • 21 CFR part 11
  • Computer systems in clinical trials
  • GAMP standard and applicable regulations