What to Expect with Computer Systems Validation Services from Transcat

Transcat’s Solutions team are experts in computer systems validation. Our efficient, time-tested process enables us to confidently verify your computer system meets documented user requirements and is configured to perform all required functions utilizing System Development Lifecycle Documentation (SDLC) to ensure all aspects of the CSV are documentation accordingly.

The classic “V Diagram” outlining the process for Computer Systems Validation was popularized by industry organizations such as ISPE via GAMP Guides. The depth and breadth of documentation/testing required is dependent upon the classification of the software being qualified.

The Solutions team will draft a Validation Plan for the project that defines the overall validation strategy, team members involved and their roles and responsibilities, and the project acceptance criteria, where applicable. 

The Computer System Impact Assessment is used to determine a computer system’s impact on product quality, patient safety, and regulatory compliance. In addition, it is used to define the GAMP Category of the Computer System. 

User Requirements Specification details the general use of the software, “what” the software shall be required to do, and any safety requirements, operational requirements or other factors specific to the organization. 

Functional (Requirements) Specification builds upon the URS and defines “how” the software functions to meet user requirements. 

Functional Requirements can also include logic and calculations, how the software ensures compliance with regulatory requirements, or details on how passwords or an audit trail process should operate. 

The Functional Risk Assessment is a tool that analyzes the Functional Specifications to identify and evaluate the potential risks associated with the computer system. Focusing on how failed functionality could affect product quality, patient safety, or regulatory compliance. 

The Design Specifications contains the technical elements of the computer system hardware and software; Hardware Design Specifications (HDS), Software Design Specification (SDS), and Configuration Specifications (CS). 

In the System Build step, software is purchased (or developed) and then configured per applicable specification documents. This step also includes unit and/or module testing, system integrations, and user acceptance testing (UAT). 

Installation Qualification tests confirm that the software or system meets the Design Specifications (HDS, SDS, and CS). The software is typically first installed and configured within a test environment (Validation Environment) that mirrors the live environment (Production Environment).  

Operational Qualification testing, also called Functional Testing or System Testing, confirms that all functionality (defined by the Functional Specification) is present and working correctly without bugs or flaws. 

Performance Qualification confirms that the software meets all requirements of its intended use (as defined in the User Requirements Specification.)  

The Traceability Matrix confirms all requirements, specifications, and test cases are clearly linked throughout the design, build, and testing project phases and can be “traced” back to the original system requirement(s). 

The Validation Final Summary Report provides confirmation that all activities specified in the validation plan have been completed, summarizes the testing results and provides confirmation that all acceptance criteria have been met and the software is ready for use. Any deviations from the original plan are also detailed in the report. 

Through risk-based validation practices that are traceable, the Transcat Solutions CSV team works with your IT, Engineering, Automation, and Quality teams to ensure your computer systems is fit for its intended use. 

Contact our team for a consultation to discuss your Computer Systems Validation needs.