Version 2.0 · Updated 2026-09-21 · Planning
Connect a credible failure to controls, evidence gaps and an assurance decision.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
A risk rating exists but the testing rationale is unclear.
- Defined intended use and important requirements
- Credible failure scenarios and consequences
- Existing controls and available evidence
Field instructions
- Failure: Describe a credible incorrect, missing or delayed result and trace it to the affected process, record or decision. Distinguish severity from how often it could occur.
- Cause/context: Describe the input, configuration or operating condition that makes the failure credible; distinguish a proposed cause from a confirmed one.
- Consequence: Trace the failure to the affected product, process, record or decision and explain why that consequence matters.
- Existing control: Describe the preventive or detective measure, responsible role and evidence that it works for the identified failure.
- Control limitation: Explain which failure paths the control does not prevent or detect, and what evidence or restriction addresses that gap.
- Existing evidence: Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- Gap: State exactly which claim is unsupported by the existing evidence and what information is missing.
- New evidence: Specify the additional test, review or observation, its expected result and the evidence to retain.
- Remaining uncertainty: Describe what the combined evidence still cannot establish and how the uncertainty limits the decision.
- Owner/action: Assign the evidence or control action to an accountable role, with a due date and completion reference.
Does each assurance activity answer an identified question? Remove activities that add no useful evidence and address unexplained gaps.
Completed fictional example
Fictional teaching example; replace its values with your own assessed facts and evidence.
Blank template
System / record ID: ____________________
Prepared by / date: ____________________
Required review / approval under local procedure: ____________________
Relevant regulations and guidance
These sources apply within their stated scope. The suggested worksheet fields, test designs and fictional decisions are practitioner recommendations, unless a source requirement is expressly identified. Completing a template does not establish compliance.
Regulatory guidance / GMP guideline · United States · February 2026
Scope: Medical-device manufacturers assuring software used in production or their quality management system.
Relevance: For medical-device production or QMS software, supports selecting assurance activities from intended use, risk and available evidence. It is nonbinding guidance and does not determine other sectors’ obligations.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →Regulatory guidance / GMP guideline · European Union · January 2011 revision
Scope: Computerised systems supporting activities in the applicable EU pharmaceutical GMP context.
Relevance: For computerised systems used in EU GMP activities, informs lifecycle, supplier and record controls. Confirm applicability to the actual activity; the example does not establish it.
Status: Final / published · Checked 2026-09-21
The Commission index confirms the January 2011 operative revision. The linked PDF could not be retrieved in this check; retained detailed section mappings need review against an authorized copy.
Read source details and applicability →Regulation · United States · Current eCFR text
Scope: Electronic records and signatures within FDA Part 11 scope, tied to the underlying required records.
Relevance: Assess applicability to electronic records required by FDA predicate rules and electronic signatures used in their place. The presence of an electronic record alone is not an applicability conclusion.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →