LIMS Validation : talk about it

ConvalidaThe 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.

For this reason, Polisystem Informatica provides its Customers:

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) :

  • A “Validation Kit” which includes :
    • Technical documentation of the software production details
    • “Correlation matrix” between paragraphs of the UNI CEI EN ISO / IEC 17025/2005 (+ Notes Rt-08 Accredia) and processes / parts / functions managed by the Software
    • Indications for proper drafting of the “Validation Plan”
    • Software Check List” (List of activities required to comply with the check lists of Accredia inspectors for what concerns the other concerning the use of computerized systems in the Laboratory)
  • Consulting Services in support of Validation :
    • Staff Training on the theoretical and practical aspects of the software validation
    • Setting and drafting of the “Validation Plan
    • Backup and Restore Test service for the verification procedures
In the event that intervention activities of the standard customization (excluding countless parameterization features offered by the standard LIMS, that already allows an high level of customization by the user) are needed, Polisystem Informatica provides all the technical documentation necessary for eventual validation activities.

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”.