ValSW: the Database for the Software Validation in Regulated environment
It is a software application, unique in his kind, designed to provide valuable support for the registration of the software validation data and the tool to produce the necessary reports to document the results of this validation.
“ValSW” born for the Software validation requirements used by companies or laboratories which operate in a “standardized” environment.
Originally, the “ValSW” Project was born for the need to properly support the LIMS Software Validation Process of Accredited Laboritories according to UNI CEI EN ISO / IEC 17025.
In the terms of the User Requirements and Functional Specifications drafting, it was decided to generalize the features in order to get a full support to the validation of any type of Process Management Software (more than one) in compliance with any reference Statement (more than one).
It is a package that allows you to put into practice “Validation Plan” drafted by the Validation Team, according to the principles of proper activities of Validation.
The registration is required for the choice of tests to be performed and the consequent management both for the “Validation I.T.” (Of one who produces the Software), both for the “User Validation” (of one who has chosen a C.O.T.S. Software and must documenting compliance with the regulations to be observed, both the correct support to its Procedures and Operational Management).
The registry of “ValSW” store the individual paragraphs of the Regulations (and the corresponding interpretative additions), the Software Packages to Validate together with the processes managed by each, the procedures defined for the environment in which the user of the Software operates.
“ValSW” realizes the “Correlation Matrices” between Regulations, Software and Procedures, allows you to set the Test Plan (I.T. and User), to duly record the performance of the test under the Plan, managing any nonconformities and Approvals.
Once completed the testing activities you can get a “Validation kit“: a complete documentation of the validation (Reports of Synthesis and Functional Test of detail for each Software Package for which the validation has been performed).