Short answer: FAT, SAT, IQ and OQ are different project stages. The supplier’s standard test, the buyer’s site acceptance and regulated qualification documents should be scoped before purchase so responsibilities, samples, utilities, data and pass/fail criteria are clear.
Decision rule: Do not buy “validation documentation” as an undefined line item. Name the protocols, deliverables, execution responsibility and approval path.
Factory acceptance testing
FAT is performed before shipment at the supplier or manufacturer location. It can verify configuration, key functions, safety features, software, accessories and agreed performance using defined inputs. Identify whether the buyer will witness remotely or onsite and what happens to open items.
Site acceptance testing
SAT confirms the delivered system after installation in the user environment. It may cover shipping damage, utilities, interfaces, functions and selected performance. SAT should distinguish installation problems from unresolved FAT items.
Installation qualification
IQ documents that the equipment and required components are installed according to approved specifications. Scope can include identification, utilities, materials, drawings, manuals, software versions and calibration status.
Operational qualification
OQ challenges defined operating functions and ranges against approved criteria. It is not automatically the same as the supplier’s functional test. The user’s quality system determines protocol format, review and approval.
Define responsibility and data ownership
State who writes, reviews, approves and executes each protocol; who supplies standards, samples and utilities; who resolves deviations; and who owns raw data and editable files. Include language, format and electronic-record requirements.
Working checklist
- FAT/SAT/IQ/OQ scope by document
- Protocol author and approver
- Witness requirements
- Samples/standards/utilities
- Acceptance criteria
- Deviation ownership
- Raw data and editable files
- Training and final turnover package
What to include in the RFQ
Attach the validation/documentation user requirement, required templates, acceptance criteria, execution location, witness expectations and list of editable deliverables.
Use the GSE technical RFQ to submit the requirement, attachments, destination and required-on-site date.
Allocate responsibilities before the purchase order
Define whether the supplier provides protocols, executes testing, supplies templates only or supports the buyer’s validation team. State the governing specification, acceptance criteria, required witnesses, deviation handling, raw-data format and approval sequence.
FAT should focus on what can be verified effectively before shipment; SAT confirms installation-site conditions and shipment integrity; IQ documents installation against approved requirements; OQ challenges defined operating functions. Avoid duplicating tests without a reason, but preserve traceability between stages.
Continue the topic: Scientific Equipment Procurement & Documentation Center.
Frequently asked questions
Is FAT the same as OQ?
No. FAT is a pre-shipment acceptance activity; OQ is a qualification activity under the user’s approved quality system.
Should the supplier execute IQ/OQ?
That depends on the contract and quality system. Responsibilities must be defined before purchase.
Why request editable files?
Editable protocols and trace matrices may be required for controlled review, site adaptation and long-term change management.
Turn this research into a controlled technical request.
Send the application, model, specification or drawing. GSE will preserve the technical lane, identify missing scope and verify current commercial details without treating website copy as an offer.
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- Completeness score
- Technical-lane routing
- No fabricated channel or inventory claims