The Software Validation requires different activities, depending on whether to validate a Standard Software Package (C.O.T.S.), or a custom software from one Standard, or rather a “Custom” Software.
The installation and subsequent operation of a LIMS Standard Software (COTS = Commercial Off The Shelf) in an Accredited Test Laboratory and / or operating under “regulated procedure” involves for the same, in addition to other duties, the availability of a series of Documents to prove that the LIMS is designed according to specifications implementing the Guidelines for computerized Systems in the field of GxP.
In short this standard feature provides documentation which shows that the product has been designed, developed, reviewed and revised according to a verifiable life cycle.
On the other hand, even the laboratory has to perform a task of “User Validation”: ie it must ensure and provide evidence that the software application does what is required by the end user, and that it does so “trustworthy” . In other words, even if the laboratory acquires a rich powerful and effective LIMS functionality, it must demonstrate documented evidence that the LIMS supports adequately the processes and procedures of that specific Laboratory.
Polisystem Informatica to support the laboratory in such activities proposed (on option) :
In addition, to support the Laboratory in the activity of logics calculations Validation set on MS / Excel, Polisystem Informatica has created two software solutions, unique in their kind, the documentation of which we refer for further details :
In recent times, the Control Bodies and Accreditation pose greater attention to aspects concerning the use of software (LIMS and other) by the Laboratory, providing in check lists of inspectors more specific tracking entries and starting to gradually demand a “canonical” software validation : the determination of the application software fairness, respect the requirements and user needs (FDA Glossary of computerized systems and development terminology; in short, you must give evidence that the software application does what is required by the end user, and that it does so “trustworthy”.