Validation
Performing – and being seen to perform
Validation is the process whereby systems of all kinds are proven to be of a certain standard or performance. Your own systems will be subject to certain regulatory bodies, and you will appreciate the level of validation that they require.
Autoscribe, therefore, can help to ensure that your LIMS solution is validated and remains so for its lifetime.
Validation comes in the form of documented evidence that a system performs as it should. You can undertake the validation process using your own resources, using Autoscribe, or using a third party.
A LIMS validation may encompass:
- Master Validation Plan – the user company is responsible for the production of this document, which includes design and testing needs, and details the validation plan.
- Quality Audit of the Supplier – your company typically visits Autoscribe to ensure that the products we provide are of the right standard.
- IQ – Installation Qualification – the installation of the infrastructure hardware and software is down to the user company, whilst Autoscribe can outline instructions for the correct installation of the system. The IQ looks at such matters as version control, security, interfaces to other systems, and the system’s impact on neighbouring solutions.
- OQ – Operational Qualification – typically the longest element of the validation, the OQ verifies that each feature and function of the LIMS operates to the standard set out in the manufacturing or requirements specification.
- PQ – Performance / Process Qualification – usually undertaken by the user company, the PQ proves the LIMS solution’s operational performance, using the customer’s own SOPs, equipment and methodologies.
- Training, Support, Maintenance, Backup and Upgrade Procedures – all of these elements must be documented to prove the viability of the solution going forward.
- Validation Summary Report
If your company requires our assistance in this vital validation procedure, please contact Autoscribe today.
