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Validation, Verification & Equipment Verification Stuart Imrie Compliance & Resource Programme Manager [email protected]
Validation, Verification &
Equipment Verification
Stuart Imrie Compliance & Resource Programme Manager
Learning Objectives
• Process and procedures for validation/
verification adopted in Glasgow
• How these have evolved, either through self
assessment or observations & findings at
UKAS visits.
• Approach to equipment verification (new and
return to use)
West of Scotland –
Laboratory Genetics
Date Assessment
Sept 2013 Molecular Diagnostics: limited re-assessment visit to
CPA standards prior to transition to UKAS
June 2014 Molecular Diagnostics: initial assessment to CPA
standards and ISO15189
Dec 2014 Molecular Diagnostics: Extra visit – confirming
transition to ISO15189 and UKAS accreditation
Feb 2016 Molecular Diagnostics: Surveillance 1
Feb 2017 Laboratory Genetics: Surveillance 2
+ ETS of Cytogenetics service
Feb 2018 Laboratory Genetics: Surveillance 3
Feb 2019 Laboratory Genetics: Full visit
Validation vs Verification
Validation:
‘Confirmation, through the provision of objective
evidence, that the requirements for a specific
intended use or application have been fulfilled’
(doing correct test)
Verification:
‘Confirmation, through the provision of objective
evidence, that specified requirements have been
fulfilled’ (doing test correctly)
Definitions (from ISO 9000:2005)
Validation of new process
• Introduction of new (unique) equipment
• Introduction of new CE/non-CE accredited methods
• Following a major change to previously validated
parameters of equipment, IT systems/software or
methods already in use in the laboratory.
• Introduction of an “in-house” test/procedure created
for use in the department
• Changes to the validation specifications of a process
issued by a manufacturer
• Standard methods used outside their intended scope
Verification of existing process
• Minor changes to a previously validated/verified method
• Protocols changed from manual to automated processing
• Periodic check of existing lab processes
• Change of supplier
• A new formulation of a reagent in routine use.
• Version update to software used for analysis/reporting.
• Introduction of new equipment (additional/replacement)
• Acceptance of equipment back into use
• Biological verification
Documenting and Recording
• Process
– Standard procedures (“how do we actually capture
we have done this?”)
• Template(s)
– Initially separate validation & verification
– Record information on details, strategy, evidence,
supporting documentation, outcome
– Independent authoriser
Recording in Q-Pulse
• Validation
– CAPA module (LGVAL-XX)
• Verification
– CAPA module (LGVER-XX)
– Asset module
Modifications to templates
• Single template
– Confusion as to which to use (staff feedback)
• Addition of checklist (self assessed need)
– To ensure SOPs, risk assessments, training, EQA
scheme, etc. completed
– Checklist updated (Finding 2017)
• Provide more space than just Y/N and more specific
statements e.g. “specify EQA scheme/alternative”
• Authoriser to confirm that reproducibility, sensitivity,
specificity & limitations have been addressed
Equipment
Validation or Verification
• Part of process validation (LGVAL-xx)
• New (additional) equipment (TEM-86)
• Acceptance back into use (TEM-87) (Finding 2016/2017)
– Microscopes, RT-PCR (MTAS)
– Pipettes
– Internal verification e.g. temperature probes, PCR (Driftcon)
• Biological verification (Finding 2017)
• Software updates
General verification form
Pipette verification
Pipette verification
Pipette verification
Read
Mean volume (µl)
Pipette verification
Pipette verification
Biological verification
Finding 2017
• 5.6.4. There was no defined means of
comparing procedures and establishing
the comparability of results for patient
samples amplified in the thermocyclers
and for patient samples sequenced in
the three ABI genetic analysers.
Biological verification
Biological verification
Software update
