Version 2.0 · Updated 2026-09-21 · Testing
Define and verify data meaning, mapping, error handling, retry, reconciliation, security, and monitoring across systems.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
For new or changed application, equipment, laboratory, data, and service interfaces.
- Source/target specification and data owners
- Approved mapping, timing and error/recovery rules
- Test access and independently checked expected results
Field instructions
- Source and destination: Identify authoritative sources, receiving systems and record identifiers. Describe supported formats, units, timing, transformations and error handling.
- Authoritative data and owner: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Data elements, units, and identifiers: Identify authoritative sources, receiving systems and record identifiers. Describe supported formats, units, timing, transformations and error handling.
- Mapping and transformation: Identify the approved rule and authoritative source. Include units, identifiers, rounding, missing values and exceptional paths that could change the result.
- Trigger and sequence: Identify the event initiating a transfer and required ordering, timing and dependencies. Specify the response to delayed or out-of-order messages.
- Acknowledgement and error handling: Specify expected ordering, acknowledgements and timeout behavior. Explain how duplicates, partial transactions and recovery are controlled and tested.
- Retry and duplicate control: Specify expected ordering, acknowledgements and timeout behavior. Explain how duplicates, partial transactions and recovery are controlled and tested.
- Security and audit trail: Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- Monitoring and reconciliation: State what will be compared or monitored, against which baseline, by whom and how often. Define discrepancy thresholds and the response.
- Positive, negative, and recovery tests: Identify the controlled transition or recovery plan, decision owner and evidence of restoration/retrieval. State how incomplete work is detected and reconciled.
- Deviations and limitations: State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- 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 →