What this is
What is validation?
What is validation?
Objective evidence that a process is capable of consistently achieving its intended result, established before the process is relied upon and re-established when it changes. It is required particularly where the resulting output cannot be verified by subsequent monitoring or inspection.
How is it different from verification?
Verification confirms that specified requirements have been fulfilled on a given occasion. Validation confirms that requirements for a specific intended use can be consistently met. Verification is a check on an output; validation is a statement about a capability, and the second requires a protocol, trials and acceptance criteria set in advance.
Scope
When is a validation record required?
This records a validation exercise. Routine verification and monitoring follow from it.
Use this template when
- Processes where the output cannot be fully verified by subsequent inspection or testing
- New processes, equipment, products or materials before production release
- Changes to a validated process, including equipment, method, material or supplier
- Cleaning validation, including allergen removal and changeover methods
- Establishing critical limits for a control point, where validation is what makes the limit defensible
Do not use it for
- Routine verification and monitoring, which confirm the validated process is operating as intended
- Equipment qualification, which establishes the equipment is installed and operating correctly and precedes validation
- First article inspection, which verifies a production process through a produced part
- Calibration, which addresses the measurement rather than the process
- Capability studies, which describe ongoing variation once the process is validated and running
Compliance mapping
Which ISO 9001 cl.8.3.4 requirements does this satisfy?
Validation is required by quality standards generally and prescriptively in regulated sectors.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 9001 cl.8.5.1(f) | Validation and periodic revalidation of processes where resulting output cannot be verified by subsequent monitoring | Header |
| ISO 9001 cl.8.3.4 | Design and development controls including validation that outputs meet requirements for the intended use | Protocol |
| 21 CFR 820.75 | Process validation for medical devices, with documented procedures, approved protocols and qualified personnel | Protocol |
| 21 CFR 117.160 | Validation of process preventive controls, providing scientific evidence the control is capable | Conclusion |
| Codex principle 3 | Establish validated critical limits, distinguishing validation from monitoring and verification | Conclusion |
| BRCGS Issue 9 | Validation of processes and control measures, with records and defined revalidation triggers | Trials |
| AS9100 cl.8.5.1.3 | Production process verification, related to but distinct from validation | Header |
| ISO 13485 cl.7.5.6 | Validation of processes for production and service provision, including software validation | Protocol |
What it does not cover
- Routine verification and monitoring, confirming the validated process is running as intended.
- Equipment qualification, establishing correct installation and operation before validation.
- First article inspection, verifying a production process through a produced part.
- Calibration, addressing the measurement system rather than the process.
- Capability studies, describing ongoing variation once the process is validated.
How to complete it
How to complete a validation record, step by step
Write the protocol first, challenge the worst case, and define what would trigger doing it again.
What is being validated, against what requirement, under what conditions, how many replicates, what measurements, and what result constitutes acceptance. Approved and dated before the first trial. This sequence is the entire basis on which the conclusion carries weight, and reconstructing it afterwards produces a record that passed by construction.
Shortest time, lowest temperature, heaviest load, largest pack, coldest incoming product, oldest equipment in the fleet, and the operator conditions actually permitted rather than the best available. A process validated at nominal settings has demonstrated something true and not useful, because production does not run at nominal.
A validation that located the boundary of the operating window is more useful than one that passed everywhere, because it tells you where the edge is. Where nothing failed at any condition tested, the conditions were probably not challenging enough, and the record should say what range was explored.
Change to equipment, material, supplier, method, product or packaging, and a defined maximum period. Written into the validation record itself, these become findable when someone later asks whether a change requires revalidation, which is a question usually asked after the change has been made.
What auditors find
Most common validation record findings
Validation findings concentrate on sequence and on what was actually challenged.
| Finding | Clause | What fixes it |
|---|---|---|
| Acceptance criteria defined after trials were completed. | 21 CFR 820.75 | Approve the protocol before running; criteria derived from results prove nothing. |
| Validation conducted at nominal rather than worst-case conditions. | 21 CFR 117.160 | Challenge the limits of the permitted operating window. |
| Verification records presented as validation. | ISO 9001 cl.8.5.1(f) | They answer different questions; verification cannot establish capability. |
| No revalidation triggers defined. | BRCGS Issue 9 | Write them into the record; the question arises after the change is made. |
| Number of replicates not justified. | 21 CFR 820.75 | State why the sample size supports a conclusion about consistency. |
| Validation not repeated after an equipment or material change. | ISO 9001 cl.8.5.1(f) | Change invalidates the evidence; link validation to management of change. |
| Cleaning method verified but never validated. | BRCGS Issue 9 | Verification confirms the method was followed; validation establishes it works. |
| Critical limits adopted from a code of practice without validation for the process. | Codex principle 3 | Validate against your product and equipment; borrowed limits are assumptions. |
| Protocol approved by someone without the technical basis to approve it. | 21 CFR 820.75 | Approval requires qualified personnel; a signature is not the requirement. |
| Validation record does not identify the equipment or configuration used. | ISO 13485 cl.7.5.6 | The evidence applies to what was validated; record it precisely. |
Case in point
Case in point: validated at the easy setting
A sealing process was validated on a heat sealer set to a dwell time and temperature in the middle of the permitted range, with product at ambient and the newest of four machines. Twenty samples were tested, all passed, and the process was released.
Production ran across all four machines, on chilled product from the packing hall, at the lower end of the dwell range when line speed increased. Seal failures appeared intermittently and were investigated as a machine fault.
The validation had established that a well-maintained machine seals warm product at nominal settings, which nobody doubted. The conditions under which the process actually ran had not been part of the exercise.
The template
The template, field by field
The form exactly as it installs. Every field, option, score and conditional rule is editable, and the links to other templates come with it.
4 sections
- Reference
- QUA-071
- Archetype
- Record
- Record ID
- VAL-2026-000
- Scoring
- Pass or fail
- Direction
- High is good
- Singleton
- No
- Basis
- ISO 9001 cl.8.3.4
- Links
- Links Change Request
- Tags
- Change, Validation
- Sections
- 4
- Fields
- 42
- Follow up fields
- 4
- Repeating sections
- 1
- Links out
- 2
Header
9 fieldsValidation ID*
Auto sequence. Format VAL-2026-0000.
The record's own ID. Other templates point at this value.
Status*
Drives who this goes to next.
- Planned2 pts
- In progress2 pts
- Complete3 pts
- Deferred0 pts
- Open0 pts
- Closed3 pts
- Overdue0 pts
Date and Time*
Raised By*
Site*
Site ID*
Format SITE-000.
Links to FDN-001 Site ID
Change Request ID*
Immediate predecessor record
Validation Type*
Process, cleaning, shelf life, thermal, allergen removal or equipment qualification.
Evidence, Not Optimism
Validation proves the change does what you expect, before it becomes standard. Without it, a change is a hope that somebody will find out about later.
Protocol
7 fieldsProtocol Written Before Testing*
Deciding what counts as success after seeing the data is not validation.
- Yes3 pts
- No0 pts
Acceptance Criteria Defined*
- Yes3 pts
- Partly1 pt
- No0 pts
Worst Case Conditions Used*
Validate at the hardest conditions, not the easiest. Thickest product, fullest load, coldest start.
- Yes3 pts
- Partly1 pt
- No0 pts
Acceptance Criteria*
Number Of Trials*
Three consecutive successful runs is the usual minimum.
Sample Size Per Trial*
Independent Testing Used
- Yes3 pts
- No1 pt
Trials
Repeats8 fieldsTrial Number*
Date*
Batch Reference
Conditions Used*
Result*
Meets Acceptance Criteria*
- Yes3 pts
- Marginal1 pt
- No0 pts
Deviations During Trial*
- None3 pts
- Minor1 pt
- Significant0 pts
Deviation Detail
Conclusion
18 fieldsTrials Passed*
Trials Failed*
Validation Successful*
- Yes3 pts
- Partly1 pt
- No0 pts
Conclusion*
Limits Of Validation Stated*
What this validation does not cover matters as much as what it does.
- Yes3 pts
- No0 pts
Revalidation Triggers Defined*
- Yes3 pts
- No0 pts
Revalidation Interval
Change Released To Standard*
- Yes3 pts
- Conditionally1 pt
- No0 pts
Documents Updated*
- Yes3 pts
- Partly1 pt
- No0 pts
Effective From
Action Required*
Raise the action record, then enter its reference here.
- No2 pts
- Yes0 pts
Priority
- High0 pts
- Medium1 pt
- Low3 pts
CAPA ID
Format CAPA-2026-00000.
Links to FDN-014 CAPA ID
Action Owner
Quality Engineering*
Signature*
Quality Manager*
Second Signature*
QUA-071 · record IDs look like VAL-2026-000 · Links Change Request
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The record establishes capability. What fails is criteria written afterwards and a window nobody challenged.
Holds the approved protocol with its date, records trials against pre-set criteria, and carries revalidation triggers on the record itself.
Connects equipment, material and method changes to the validations that depend on them, so revalidation is raised before production continues.
Links validated processes to the specific equipment and configuration used, since validation evidence applies to what was validated.
Confirms that those approving protocols and interpreting results have the technical basis the standards require.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Validation Record definitions and key terms
- Validation
- Objective evidence that a process can consistently achieve its intended result, established before reliance and re-established on change.
- Verification
- Confirmation that specified requirements have been fulfilled on a given occasion.
- Protocol
- The approved plan defining what will be tested, under what conditions, how many times and what constitutes acceptance.
- Worst case
- The most challenging combination of conditions within the permitted operating window, which is where validation should be performed.
- Special process
- A process whose output cannot be fully verified by subsequent inspection, such as welding, sterilisation, sealing or heat treatment.
- Revalidation
- Repeating validation following change or after a defined period, with the triggers ideally written into the original record.
- Equipment qualification
- Establishing that equipment is correctly installed and operating as intended, preceding process validation.
- Operating window
- The range of conditions within which the process is permitted to run, and the range validation should challenge.
FAQ
Frequently asked questions about validation record
What is the difference between validation and verification?+
Verification confirms that requirements were met on a given occasion, by inspecting or testing the output. Validation establishes that the process is capable of consistently meeting requirements, which is a statement about capability rather than about one result. Verification cannot substitute for validation, particularly where the output cannot be fully inspected.
Which processes need validation?+
Those where the resulting output cannot be verified by subsequent monitoring or measurement, which ISO 9001 states explicitly. In practice: sterilisation, welding, sealing, heat treatment, coating, cleaning and allergen removal. You cannot inspect a seal to know it will hold, or a cleaned surface to know the allergen is gone, without destroying or testing every unit.
Why must acceptance criteria come first?+
Because criteria written after the results are known describe what happened rather than what was required, and the exercise then passes by construction. The protocol, including conditions, replicates and acceptance criteria, has to be approved and dated before the first trial for the conclusion to carry any weight.
What conditions should be used?+
The worst case within the permitted operating window: shortest time, lowest temperature, heaviest load, coldest incoming product, the oldest equipment in the fleet. Production runs across the whole window and the whole fleet, and a validation at nominal settings demonstrates something nobody was in doubt about.
When does validation need repeating?+
On change to equipment, material, supplier, method, product or packaging, and after a defined period. Writing those triggers into the validation record itself makes them findable when someone later asks whether a change requires revalidation, which is usually asked after the change has already been made.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in Change Control
Management of Change
Makes sure a change to equipment, materials, people or process is assessed before it happens rather than after
Waiver and Concession Record
Records a documented decision to proceed outside the normal requirement, with the risk accepted and by whom
Interim Control Record
Records the temporary control holding a risk while the permanent fix is built, with the date it must be replaced
Equipment Specification Record
Holds the specification a new machine must meet, covering performance, safety, hygiene, energy and maintenance access
Product Change Request
Requests a change to a product, its specification or its packaging
Process Change Request
Requests a change to how a product is made, including equipment, settings or sequence
More in Change Control
Written and reviewed by
Siddarth Singh
Founder & Chief Executive Officer, Knowella
Certified Safety Professional and industrial and systems engineer with more than a decade inside food supply chain, freight and manufacturing operations. This page was written against the current text of the standards it cites, not against secondary summaries of them.
- Certified Safety Professional (CSP), Board of Certified Safety Professionals
- MBA, University of Chicago Booth School of Business
- MS and BS, The Ohio State University, Industrial and Systems Engineering
- Six Sigma Black Belt
Sources and last review. Reviewed 16 August 2026 against:
- ISO 9001:2015 clauses 8.3.4 and 8.5.1
- 21 CFR 820.75, process validation, FDA
- 21 CFR 117.160, validation of preventive controls, FDA
- ISO 13485:2016 clause 7.5.6, validation of processes for production and service provision
- Codex Alimentarius CXG 69, guidelines for the validation of food safety control measures
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.