Version 2.0 · Updated 2026-09-21 · Assessment
Separate platform assurance from locally configured GxP rules, workflows, permissions, interfaces, records, and releases.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
For citizen-developed or centrally configured low-code and no-code applications.
- Application/platform configuration and intended use
- Local workflow rules, permissions and interfaces
- Developer governance, release controls and test evidence
Field instructions
- Platform and supplier: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Application owner and developer: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Intended use and prohibited use: State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- GxP functions: Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- Local rules and workflow: Identify the approved rule and authoritative source. Include units, identifiers, rounding, missing values and exceptional paths that could change the result.
- Permissions and segregation: Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- Interfaces and data: Identify authoritative sources, receiving systems and record identifiers. Describe supported formats, units, timing, transformations and error handling.
- Electronic records and signatures: Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- Environment and deployment: Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- Testing and evidence: Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- Change and citizen-developer governance: Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- Conclusion and approval: Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
Define the specific system, service, change, population, and intended use.
Complete each field from available records and accountable interviews; record unknowns rather than guessing.
Link conclusions to affected GxP functions, failure scenarios, controls, evidence, and approval.
Adapt the structure to the organization’s approved procedures and document-control process.
Completed fictional example
Fictional teaching example; this is not an executed or approved validation record.
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 →