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Computer System Validation

Risk-based validation of computer systems in Pharma, Biotech, and other regulated environments

Are you planning to validate your computer in a short time and in compliance with the requirements?

Valicare efficiently supports you in implementing the requirements for computer system validation (CSV) in GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and for medical devices.


As often the problem lies in the detail

Basic requirements related to computerized systems differ in detail, which can cause issues in inspections. For example, in various countries source codes must be available in a GLP-regulated test facility or must to be obtained timely. In the GMP-regulated environment, however, this requirement does not exist.

In the GCP, GMP and GDP area, the guide "Good Automated Manufacturing Practice 5" (GAMP 5) of the International Society for Pharmaceutical Engineering (ISPE) has prevailed as a guideline for practical implementation.

In the GLP area, at least Germany follows OECD Guideline No. 17 and Annex 3 of the Manual for the Performance of GLP inspections.

Depending on the complexity and criticality of the system, individual checks which are typically part of an entire validation can be risk-based assessed and omitted.

CSV diagram with subdivision into GMP, GDP, medical devices

The essential regulatory requirements and recommendations:

Our experts are familiar with the refinements and details of the relevant regulations and will guide you safely to your goal. Our expertise is based on many years of successful implementation of GxP-CSV projects (incl. medical devices).

Our strengths are:

  • We have ready and proven concepts and work instructions for CSV for both existing and newly purchased systems.
  • We apply the industry standard to validate the systems comprehensively.
  • We refer to our expertise in validation, qualification, and verification.

Your benefit from working with us is the fast and competent implementation of your computer system validation project, the assurance of meeting regulatory requirements and therefore a good basis for passing upcoming inspections successfully.

Hardware and software are included. The entire product life cycle is considered as risk-based approach, from planning to decommissioning covering operating environments, networks, and databases if necessary.

Consulting projects often start with an inventory

At the beginning of the consultation, our experts review the current state, including the distribution of roles. Especially in CSV, several groups of people are often involved, such as IT, quality assurance, users, and the validation team. Usually in a first step, the roles must be defined and distinguished from the individual areas, and the requirements and responsibilities for validation must be coordinated.

  • Our CSV services: Consulting, Documentation & Implementation

    Valicare provides you external consultancy and execution services regarding the whole CSV process.

    On consulting level, we offer the following services to our clients:

    • CSV consulting (project or topic related or on daily basis)
    • CSV basic & advanced educational training
    • CSV project management
    • Code reviews
    • Planning of validation & review or preparation of the validation master plan
    • Execution of risk assessment, risk analyses and generation/review of the traceability matrix
    • Prepare and review standard operating procedures for the design and operation, and installation and disposal of hard- and software

    On documentation level we offer the preparation of validation documents (design & planning documents):

    • User requirements specification (URS)
    • Functional specification (FS)
    • Software design specification (SDS)
    • Hardware design specification (HDS)
    • Software module design specification (SMDS) for software category 5 according GAMP5
    • Plans & protocols for:
      • Alarm and function testing (AFT) plan for PLC & HMI systems
      • Software module testing (SMT) respectively unit testing (UT)
      • Configuration testing
      • Requirements testing
      • Integration testing
      • Definition and preparation of test cases

    In the “hands on” validation execution we support our customers exemplarily with:

    • Verification of software module design specification by executing software module testing.
    • Verification of software design specification by executing alarm and function testing for HMI, SCADA, and Vision systems.
    • Performing testing and verification to ensure systems operate as intended and meet regulatory expectations.
    • Verification of functional specification and hardware design specification by executing alarm and function testing for PLC systems, motion controllers and robot systems.
    • Preparation of test protocols

    We are also your partner for changes to already validated systems or the validation of special systems or tools:

    • Change control:
      • Assisting in managing changes to validated systems by evaluating their impact, updating documentation, and executing necessary re-validation.
    • Validation of:
      • Excel spreadsheets
      • Computer-aided laboratory systems
      • Laboratory information management systems (LIMS)
      • Manufacturing execution systems (MES)
      • Electronic signatures
      • Audit trails
      • Electronic batch record/-report

    Our services are based on your requirements. We offer the desired validation, from pure consulting to processing of individual subareas to complete implementation including documentation.

Ellen Sons Brinkmann

First consultation free- contact us now!

Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709