Acceptance evidence with explicit boundaries
Use each test stage to answer the right acceptance question—and retain the evidence needed for release.
Axiotech develops and executes scoped supplier FAT/SAT evidence and supports customer IQ/OQ activity where agreed. Preconditions, environment, expected results, deviations, responsibilities and approvals remain explicit.
Good fit
Use this service when
- Automation and machine systems with a defined acceptance baseline and available test environment.
- Supplier testing plus regulated customer qualification support under a responsibility matrix.
Scope boundary
Not assumed or silently included
- Calling supplier testing IQ/OQ without the customer validation plan, authority and procedural context.
- Signing customer quality approvals or accepting deviations outside delegated authority.
Why act
The operational risk behind the technical symptom
The first work package is shaped around reducing an explicit risk or enabling a named decision.
Tests pass against an uncontrolled or incorrect software/configuration baseline.
Expected results are subjective, preventing repeatable acceptance and defect classification.
Deviations are closed administratively without evidence of impact and retest.
Purchasable entry points
Choose a bounded engagement before expanding scope
Final inclusions, dependencies, location, schedule and commercial terms are confirmed in a formal quotation.
Package 1
Verification strategy & protocol design
Decision enabled: A risk-based allocation of evidence to test stages.
Package 2
FAT or SAT execution support
Decision enabled: Controlled execution evidence and a dispositioned exception record.
Package 3
IQ/OQ engineering support
Decision enabled: Supplier technical evidence integrated into customer qualification.
Artefact manifest
What remains after the engineering work
The exact document set scales with risk and the approved work package.
- Verification strategy and responsibility allocation
- Approved protocol, prerequisites and test-data record
- Software/hardware/configuration baseline evidence
- Executed results, objective evidence and witness record
- Deviation, defect, retest and summary report inputs
Technical and responsibility boundaries
Make ownership reviewable
- Test stage, environment, authority and acceptance owner are stated on each protocol.
- Safety, process and product tests use appropriate competent owners and calibrated resources.
- Axiotech signs only the roles delegated in the approved responsibility matrix.
Review and acceptance
Six gates from authority to handover
Gate depth changes with the work; named decisions and evidence remain.
- G0Scope authorityOutcome, boundaries, roles, assumptions and commercial basis agreed.
- G1Baseline acceptedKnown installed/source state, dependencies, constraints and unknowns recorded.
- G2Design approvedRequirements, interfaces, risks and acceptance evidence ready for implementation.
- G3Release candidateBuild reviewed, verified, versioned and accompanied by defect disposition.
- G4Site acceptanceCommissioning evidence, deviations and release decision recorded.
- G5Handover acceptedSource, configuration, records, recovery and residual risks transferred.
Assurance option
Compliance is a declared scope—not a badge
FAT and SAT are supplier/customer acceptance stages; IQ/OQ terminology and approvals belong within the regulated organisation’s validation framework. Evidence may be leveraged across stages only where equivalence, control and rationale are approved.
Review validation servicesRelevant engineering evidence
Risk-to-test allocation and evidence model
A reusable protocol framework connecting acceptance criteria, test environment, baseline, objective evidence, deviations and approval roles.
Procurement FAQ
Questions to resolve before quotation
Can FAT evidence be reused for OQ?
Potentially, where the validation plan accepts leverage and the environment, baseline, control, traceability and evidence meet the intended purpose.
Who writes and approves protocols?
Authorship, technical review, quality approval, witnessing and final acceptance are allocated before execution.
What happens when a test fails?
Execution records the actual result and objective evidence; defect/deviation impact, correction, retest and acceptance are then dispositioned by the named authorities.
Next decision
Describe the outcome, installed baseline and constraints you already know.
Use “Not known” where evidence is missing. The first review will separate facts, assumptions and discovery work.