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LIMS validation record

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Guest user Created:   Mar 10, 2021 Last commented:   Mar 10, 2021

LIMS validation record

Does this validation record apply for pharmaceutical industry. Actually we are planning to do a LIMS validation , can you help us with the same

 

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Mar 10, 2021

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/

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Mar 10, 2021

Mar 10, 2021

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