Computer System Validation Consulting

When you work with GXP WAY, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs, we fully understand that computer systems are a key element of a company’s success. Our specific areas of expertise within computer systems validation are included below. Developing and bringing to market life-changing drugs and devices: that’s your job. Expert computer systems validation consulting: that’s ours.


You have enough to accomplish, let us be your resource for computer systems validation. As a leader specialized in computer systems validation consulting services, GXP WAY works to ensure life sciences companies’ processes are functional and in full compliance with FDA and EMA guidelines. We guarantee these systems are running efficiently and accurately when you work with GXP WAY.

Computer System Validation Consulting Use the best methods for validating and monitoring computerised systems.

Which regulations can GXP WAY audit?

  • Be ready for FDA inspections and audits.
  • Comply with legal requirements.
  • Save valuable time for corrections.
  • The validation proves with documentation that computer systems used in industrial production adequately fulfill their automatic functions and contribute to ensure the traceability of produced batches and meets GMP regulations. Every computer system that has a direct or indirect relation to the production of the medicine, product for health or impact on traceability, must be validated, because it is a GxP system.
    The first important activity of the Computer Systems Validation professional is to gather all the available documentation about the system which is object of the study.

  • In addition to contributing for data quality and data integrity, the GMP validation lifecycle is valuable because it allows:
    • Extracting all the needed available resources in the system to cover the specific process safely; • Make the technical knowledge team more in-depth about the system, avoiding that the knowledge stays entirely on the hands of the supplier (opening the “black box”); • Document technical discoveries, avoiding the loss of knowledge in an eventual exit of professionals of the company (risk to the business!); • Explore all possible automatic features in order to avoid manual steps, leading to repeatability and reproducibility for the process (target of validation!); • Direct the team to analyze necessary actions and documented procedures for contingency planning, data backup and application, and disaster recovery, reducing production downtime (risk to the business!); • Reliability of process information avoiding operational errors.

GAMP5® is a Good Automated Manufacturing Practice guide that is currently in its version 5 and was released in 2008. Since then, it has revolutionized the Validating Computer Systems method.
The guide is the main source of “inspiration” for Computer Validation professionals and has as its central axis the risk-based validation strategy (“A Risk-Based Approach to Compliant GxP Computerized Systems”).

Note.: although each company has its specificity, there are several standard processes within a type of system, for example purchasing processes within an ERP, which are common to different companies. Taking this opportunity, FIVE has developed a paperless e-validation software named GO!FIVE®, where users can select multiple libraries, according to the process or system they want to validate, and these libraries contain good market practices, regulatory requirements and much more. Click here and know our Paperless Validation Software.

GxP is a general term for the application of good practices. The ‘x’ indicates the area in which good practices are related (manufacturing, distribution, clinical research, laboratory, etc.). The relevant GxP system is any and all system that has impact on:

  • Patient health;
  • Product quality;
  • Data integrity.

The best way to validate is undoubtedly, risk-based, whether it is a new system (prospective validation) or a legacy system (concurrent validation). If the risk results in ‘medium’ and ‘high’ levels, a mitigation measure should be envisaged. If mitigation or upgrade isn’t possible, system exchange should be considered.

Validation Guide

URS – User Requirement Specification

Normally, these “medium” and “high” risk mitigation measures are detailed in the User Requirement Specification (URS), which becomes the reference document for system validation. If it is a non-configurable system, tests should basically be drawn up to prove that URS requirements have been met and some other typical system tests covered in the following GMP testing phases:

  • Installation Qualification;
  • Operational Qualification;
  • Performance Qualification.

If the system is configured or customized to meet the needs of the user company, specification documents must be produced. Some examples:

  • Functional Specification;
  • Hardware Design;
  • Software Design.

GAMP5® guide detail the exact life cycle required for each type of system and separate them as follows:



Category 1

Infrastructure Software

Category 3

Non configurable product

Category 4

Configured product

Category 5

Custom application

It is important to note that acquiring the vendor’s document package doesn’t reflect the completion of the validation work. It is necessary to “open” the document life cycle, with the issuance of the Validation Plan, Functional Risk Assessment and URS and “close” the lifecycle with the issuance of the performance test protocol, Traceability Matrix and Validation Report, documents that are not normally part of the solution provider’s scope.

Classification / Categorization of Computerized Systems

How we can support you with Computer System Validation Consulting ?

  • Identification of gaps to the status quo of the company
  • Identification of pain points or key enablers in order to achieve a significant improvement in the short and long term
  • Identification of regulatory requirements
  • Draw up the essential requirements in comparison with the customer's status quo landscape
  • High Level Review of processes
  • harmonization of procedures
  • Creation of checklists for CSV assessments
  • Process monitoring and life cycle management
  • Improvement through digitization
  • Trainings and workshops
  • Identification of the most important stakeholders
  • Visual performance management
  • Draft project roadmap
  • Detailed implementation planning
  • Creation and implementation of URS, IQ, OQ, PQ
  • Categorization and classification of validation complexity
  • Continuous improvement and regular validation throughout the life cycle
  • Project Management
  • Perform CSV for device-software combinations or software
  • Operational and advisory support

If you are new to Computer System Validation, we are here to help. Arrange a consultation appointment now Get help from experts. Our validation consultants can help you implement a CSV program from scratch, or identify process improvements and incorporate risk-based practices into your existing methodology.

If you would like to have a conversation about any of the above, please get in touch with us.