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LIMS validation

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

LIMS validation

Please let me know if you have templates for LIMS validation (Computer System Validation) as par with USFDA part 11

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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 Toolkit includes a Laboratory Information Management System (LIMS) Validation Register and generic template for a LIMS record. These are associated with the Quality Assurance Procedure. The record guides the user to record the purpose and type of test planned. Then the Test case and Procedure , Acceptance criteria and Comments / Action required can be recorded. All the other felds are provided, for example for additional comments / monitoring of risk, record of person performing the validation and approving the validation.

It is the laboratory’s role to identify the criteria and list them in the record. This reinforces the awareness and consideration of the needs. The latest Part 11, Electronic Records; Electronic Signatures - Scope and Application is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application 
To view a preview of the Advisera 17025 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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