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Software Validation

We work with local and global MedTech and Pharma companies to support software validation from requirements definition and risk assessment through development to successful testing and validation documentation of customer-developed and off-the-shelf software.

Software Validation
Regulatory compliance

Regulatory compliance

We validate software in line with your company guidelines and international standards, including:

  • FDA general principles of Software Validation

  • FDA 21 CFR part 11

  • Electronic records

  • Electronic signatures

  • EU GMP, Vol. 4 Annex 11, ‘Computerized Systems’

  • Regulatory guidance and strategy

  • Process and documentation gap analysis

  • Authoring and implementing SOPs, work procedures, and document templates

  • Audit preparation and support

Operational project support

Operational project support

We provide operational project management support (Waterfall or Agile) in accordance with current EU and US regulatory expectations and requirements, including 21 CFR 11 and EU GMP Annex 11.

  • Validation planning, including initial risk assessment (validation plan & system risk assessment)

  • Business analysis and user requirements definition (User Requirements Specification)

  • Translation of user requirements into software functions (Functional Specification)

  • Functional Risk Assessment

  • Test planning and design (Test Plan, Test Cases)

  • Test Report and Validation Report

System-related risk management

System-related risk management

We follow the approach of risk-based validation and testing as called for by the updated General Principles of Software Validation FDA guidance and other international standards. Validation and test activities must focus on the critical aspects related to patients and users, product quality, and data integrity. We consider all possible risks and benefits, using the guiding principle, “Test as much as needed, but as little as possible.”

  • Initial System Risk Assessment

  • Functional Risk Assessment

  • Documentation of residual risks

  • Risk assessment updates

  • Supporting risk management reviews and reporting