This document outlines the steps for assessing and implementing changes to laboratory processes, systems, or products. It involves determining if the proposed change is fully verifiable and cost-effective. If not, the product or process must be redesign. It then details verifying and validating the change through testing, updating documentation, providing training, and getting final approval before implementation. The goal is to thoughtfully assess and qualify any changes to ensure outputs remain valid and documentation is updated.
1. Impact and Risk Assessment
Request for change on laboratory / processes/
system
Is process
Is verification
Output
Yes sufficient &
fully
Cost Effective
verifiable
Redesign Product
No No Yes
&/or Process
Redesign Product
and/or Process or
Validate Does
documentation
need changing?
Perform Qualification
Yes No
& /or Validation
Documentation
Approve
Update documentation via
document control system No change to
documentation No
additional training
required
Training - task based SOP
Competency assessment
Review, sign off and
Implement change
close change
Source Process validation Guidance
adapted by Blackh@live.be
