All laboratories operating in regulated industries, such as the GxP industries require strict validation of information systems that deal with important analytical data and subsequent documentation. These businesses are required to produce evidence to regulatory authorities, such as the FDA and MHRA, that the system has been properly validated. This again is a time consuming and expensive task and in some cases the cost of LIMS validation can be more that of the software itself.

LabHQ software has been designed, tested and maintained using the company’s Computer System Validation Process (CSVP) which meets regulatory expectations and is easily capable of being validated for use within a GxP environment.

What is Validation?

In its basic form, validation is a documented process of demonstrating that a product or process is doing the right thing and doing it right. The US Food and Drug Administration (FDA) in 1987 defined validation as “”Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”. This definition was originally applied to the drug manufacturing processes, but has since been expanded to include associated drug-related activities including analytical methods and computer systems used in regulated processes.

There is an expectation that validation should allow quality to be built into all stages of a regulated system’s life cycle, in order to minimise system errors, problems and the risk of a system not maintaining its validated state, any of which may a) prove expensive to fix and b) more importantly, may be responsible for causing harm to a patient. The latter is the single key driving force behind the regulatory necessity for validation. In order to achieve this we use the concept of a validation lifecycle, which sits alongside a product’s life cycle (in this case the product being a computer system). In this context, a computer system is any system used to perform a business function, and includes computer hardware, software, procedures and people.

The LabHQ Computer System Validation Process

CSVP includes a number of phases that mirror the system life cycle. These are:

Planning
Design and Build
Installation
Testing
Reporting and Release
Use/Support
Retirement

For more detailed information on each of these stages, please download our full computer system validation document