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.

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.