Software validation

Software validation is a crucial building block in the life cycle of computerized systems for manufacturers of medical devices and companies in the pharmaceutical industry. Software validation refers to the documented software life cycle of a software product. This usually includes all phases from planning and requirements management to specification, coding, testing and release of a software product. Well-developed, tested and documented software enables the software manufacturer to efficiently maintain and further develop its product and provides the customer with a stable basis for its computerized system to automate its business processes. Well-validated software is a basic prerequisite for implementation and operation in a GxP-regulated environment. The quality and transparency of software validation is therefore a decisive aspect in the selection of software products and suppliers in the GxP-regulated environment. Effective compliance marketing can make the difference in the purchasing decision.


  • Planning including specifications, implementation and realization of a life cycle model (agile or linear)
  • Definition of roles and responsibilities
  • Elicitation and management of requirements (incl. regulatory and security requirements)
  • Definition and management of architecture and design
  • Risk management
  • Test strategy and test planning (automated / manual)
  • Release, implementation and operational operation (on-premise or in the cloud)
  • Optimal use of the software development tool chain for documentation
  • Change management
  • Compliance marketing strategy
  • Implementation of mock audits (preparation for audits and inspections)
  • Audit training and support
  • Vendor qualification
  • Specialized GxP training for software vendors

Software validation by QFINITY fulfills the relevant regulatory requirements set out in various regulations and guidelines, depending on the customer’s specific task:

  • EU EudraLex Volume 4 EU GMP Guideline in particular
    • Chapter 4: Documentation
    • Annex 15: Qualification and validation
    • Appendix 11: Computerized systems
  • US FDA 21 CFR Part 210

    Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

  • US FDA 21 CFR Part 211

    Current Good Manufacturing Practice for finished Pharmaceuticals

  • US FDA 21 CFR Part 820

    Quality System Regulation

  • US FDA 21 CFR Part 11

    Electronic Records; Electronic Signatures

  • US FDA

    Guidance for Industry General Principles of Software Validation

  • ICH E6 (R2)

    GiGood Clinical Practice

  • ISO 62304
    • Medical device software
    • Software lifecycle processes
  • ISO 82304

    Health software Part 1: General requirements for product safety

  • ISO 80001

    Medical device software Part 2: Validation of software for medical device quality systems

  • PIC/S-Guidance PI 011-3

    Good practice for computerized systems in the regulated “GxP” environment

  • GAMP 5 Second Edition

    A risk-based approach for compliant GxP computerized systems


Put simply, software validation is a documented process that reproducibly and consistently ensures that software provides the predefined functions. It is therefore an important aspect of quality assurance and successful software validation is the basis for the subsequent use of the software in a validated computer-aided system.

QFINITY’s innovative software validation is characterized, among other things, by quality tailored to the customer’s requirements and customized solutions for all demands. Our methods and procedures are based on the experience we have gained with over 150 customers. We involve our customers closely right from the start and thus ensure that pre-defined goals are achieved.

Die Software Validierung stellt im Rahmen ihrer Funktionen einen unverzichtbaren Baustein auf dem Weg zu einem validierten computergestützten System dar. Gerade im pharmazeutischen und medizintechnischen Bereich ist die Qualitätssicherung (von Software) essenziell. Unsere Software Validierung ist ein wesentlicher Baustein zur Erreichung einer Gesamt GxP-Compliance.


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