What is Validation?

Many of our customers operate in regulated industries and face the challenging task of performing some level of validation or verification for their computer applications. The FDA defines computer validation as Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” Whereas, verification is defined as “ ... providing objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase...”.

Government agencies require that regulated industries’ computer systems be assessed for the need for validation. If it is determined that validation is required, however, these regulatory bodies do not specify how to validate the system. Therein arises the dilemma for some customers. In an effort to provide guidance to industry, GAMP has provided well accepted, time tested methodologies for the industry in validating software systems. International bodies (Eudralex, PICS, EMEA, PMDA, etc.), endorse GAMP’s ‘V’ model, as does LabWare Services.

As part of the initial project definition and requirements gathering, it can be determined whether or not validation is required. The client’s industry, level of regulation and internal compliance climate, can influence the validation strategy. Validation activities parallel those of a project throughout the SDLC methodology – from Concept/ Planning through Retirement.

ISPE’s GAMP 5 recommends the leveraging of vendor (FAT) testing as well as endorsing a more risk based approach to validation. It is frequently difficult for customers to assess the risk as it pertains to their own particular industry and configuration.

LabWare Services understands that some customers’ projects in R&D, Process Development, Genotyping, DNA Analysis, etc. may not require a formal validation effort. Some level of verification takes place, however full blown validation may not always be warranted. Nevertheless, whether you’re part of a regulated industry or not, a basic level of verification or validation just makes good business sense!