LIMS validation record

The validation record is generic and can typically be used as is for any sector. The record can be revised if necessary, or customised by the laboratory for a specific purpose. The record is a tool to “house” specific requirements that an individual laboratory has.

What is important is that the laboratory has knowledge of the guideliens and requirements for its sector. For Pharmaeutical, for example, The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) document PI 011-3 PIC/S Guidance Good Practices for Computerised Systems in Regulated “GXP” Environments, available at https://picscheme.org/docview/3444

To view a preview of the toolkit and the LIMS register and record, you can go to https://advisera.com/17025academy/iso-17025-documentation-toolkit/