Validation, Verification &

Equipment Verification

Stuart Imrie Compliance & Resource Programme Manager

stuart.imrie@ggc.scot.nhs.uk

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