Skip to content
Docsie Logo

Free Downloadable Template

Free Validation Package (IQ/OQ/PQ) Template

Qualification package for equipment, utilities, systems, or processes: plan, requirements, IQ, OQ, PQ, and report. Download the editable blank, or create a draft from your recordings in Docsie.

Purpose and Scope Validation Approach Requirements and Acceptance Criteria Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Deviations
Word PDF Markdown
Create in Docsie All long-form templates

Assemble the qualification plan, protocols, execution records and reports for one system. Complete acceptance criteria before execution; keep actual results, signatures and stage decisions blank until recorded by authorized personnel. Copy the protocol module for each applicable stage or test group.

Complete bracketed fields with approved information. Duplicate modules and rows as needed; record the reason for any section marked not applicable.

Document [ID and revision] Owner [Role] Scope [Organization, site or product]

Effective date [Date] Approval [Controlled record] Next review [Date or trigger]

Validation plan

Plan element System specific decision
System intended use and boundary [System ID, components, interfaces, GxP impact and exclusions]
Strategy and applicable stages [DQ, FAT, SAT, IQ, OQ, PQ or combined stages; approved rationale]
Risk based scope [Method, assessment reference and critical functions]
Roles and stage gates [Author, reviewer, executor, quality and release authority]
Governing documents [Plan, requirements, procedures and change-control references]

Requirements and design

Requirement ID Exact requirement and risk link Specification and test reference
[URS ID] [Requirement, units and criticality from approved assessment] [FS/DS ID, DQ evidence and planned test]
[URS ID] [Requirement] [Specification and evidence]

Design qualification and supplier assessment

Design or supplier question Evidence examined Decision and open item
[Requirement or supplier capability] [Design review, assessment or document] [Authorized conclusion and action]

Factory and site acceptance testing

Acceptance activity Scope and protocol Result reference and gaps
[FAT or SAT where applicable] [System, configuration, prerequisites and approved protocol] [Executed report, deviations and decision]

Installation qualification

Repeatable qualification protocol

Use this module for IQ, then copy it under OQ or PQ with the stage-specific conditions. Do not split one test case across records. | Protocol setup | Complete before execution | |---|---| | Protocol ID objective and scope | [Stage, system/subsystem and test group] | | Configuration and prerequisites | [Hardware/software versions, prior stage, approved procedures and trained roles] | | Instruments and materials | [Instrument IDs, calibration status, materials and traceability] | | Conditions and sampling rationale | [Ranges, worst-case conditions, sample size and approved rationale] | | Recording and deviation method | [Raw-data location, evaluation method and deviation route] |

Test ID and requirement Test step Expected result and acceptance criterion
[Test ID; URS/risk ID] [One executable action with exact setpoint and units] [Observable result and approved criterion]
[Test ID] [Next action] [Expected result and criterion]

Execution record

Test ID Actual result and raw data Outcome and execution record
[ID] [Leave unexecuted until performed; record values and units] [Pass/Fail only after evaluation; executor and date]
[ID] [Raw-data reference and observation] [Outcome or deviation ID]
Stage report Executed scope deviations and decision
IQ report reference [Executed/not executed tests, results, deviations, conclusion and authorization to proceed]

Operational qualification

Copy the protocol and execution module above. Define operating ranges and challenge conditions before execution. | OQ planning and report | Controlled record | |---|---| | Functions and operating limits challenged | [Test IDs, ranges, alarms, interlocks and approved criteria] | | Coverage and prerequisites | [Prior-stage status, instruments and test conditions] | | Executed result and conclusion | [Raw data, deviations, report and authorized next-stage decision] |

Performance qualification

Copy the protocol and execution module for representative operation, process performance, cleaning or utilities as applicable. | PQ planning and report | Controlled record | |---|---| | Routine conditions and sampling | [Materials, personnel, runs, sampling rationale and approved criteria] | | Critical parameters and attributes | [CPP/CQA IDs, limits, units and evidence] | | Executed result and conclusion | [Data, variation, deviations and report; no assumed release] |

Deviations and traceability

Deviation and affected test Assessment and correction Closure evidence and decision
[ID, observation and test ID] [Impact, cause, action and retest rationale] [Evidence, reviewer and status]
Requirement and risk Test or evidence Result and unresolved gap
[URS/risk ID] [Protocol, test and report] [Recorded outcome and open item]

Validation summary report

Summary question Recorded conclusion and evidence
What was executed [Stages, protocol versions, configurations and omitted tests with reasons]
Were acceptance criteria met [Result summary, deviations and evidence; do not infer pass]
What remains open [Conditions, risks, restrictions, owner and target date]
Is progression or release authorized [Decision, authority, approval reference and operating boundary]

Maintaining the validated state

Controlled activity Adopted rule and trigger Evidence and responsibility
Change control [Impact assessment, approval and requalification criteria] [Change record and authority]
Periodic review or verification [Frequency, inputs, method and criteria] [Review result and actions]
Operation cleaning and maintenance [Qualified ranges, procedure and competence] [Logs, exceptions and review]

Glossary

Term Meaning in this package Source
[URS IQ OQ PQ or other term] [Expansion and adopted meaning] [Controlled reference]

Package completeness check

  • [ ] Protocols and criteria were approved before execution and raw data is traceable.
  • [ ] Actual results, deviations and decisions are recorded without prefilled outcomes.
  • [ ] Traceability, open items and qualified operating limits are reviewed before release. | Review role | Date and decision | Signature or approval record | |---|---|---| | [Engineering, validation or quality authority] | [Approved or returned] | [Controlled reference and conditions] |

8 Repeatable Chapter Patterns

One document plan. The right structure for each chapter.

Teams preparing a validation package (iq/oq/pq) from existing source material. Repeat a procedure, checklist, or reference chapter where needed, and keep only the sections your source material supports.

1

Overview

Set the purpose, scope, audience, and boundaries before the detailed chapters.

2

Policy or standard

Keep policy statements and requirements together with their scope and responsibilities.

3

Roles and responsibilities

Show who performs each activity, who decides, and when to escalate.

4

Reference

Keep exact settings, field values, commands, and supporting references easy to look up.

5

Procedure

Give each task its prerequisites, ordered actions, expected result, and verification.

6

Glossary

Define the terms and abbreviations used throughout the document.

7

Qualification protocol

Document qualification scope, prerequisites, methods, acceptance criteria, and evidence to record.

8

Validation report

Connect validation scope and methods to recorded results, deviations, evidence, and conclusions.

Suggested document outline

  • Purpose and Scope
  • Validation Approach
  • Requirements and Acceptance Criteria
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Deviations
  • Traceability Matrix
  • Validation Summary and Release
  • Maintaining the Validated State

Inside the editable blank

Assemble the qualification plan, protocols, execution records and reports for one system. Complete acceptance criteria before execution; keep actual results, signatures and stage decisions blank until recorded by authorized personnel. Copy the protocol module for each applicable stage or test group.

Complete bracketed fields with approved information. Duplicate modules and rows as needed; record the reason for any section marked not applicable.

Document [ID and revision] Owner [Role] Scope [Organization, site or product]

Effective date [Date] Approval [Controlled record] Next review [Date or trigger]

Validation plan

Plan element System specific decision
System intended use and boundary [System ID, components, interfaces, GxP impact and exclusions]
Strategy and applicable stages [DQ, FAT, SAT, IQ, OQ, PQ or combined stages; approved rationale]
Risk based scope [Method, assessment reference and critical functions]
Roles and stage gates [Author, reviewer, executor, quality and release authority]
Governing documents [Plan, requirements, procedures and change-control references]

Requirements and design

Requirement ID Exact requirement and risk link Specification and test reference
[URS ID] [Requirement, units and criticality from approved assessment] [FS/DS ID, DQ evidence and planned test]
[URS ID] [Requirement] [Specification and evidence]

Design qualification and supplier assessment

Design or supplier question Evidence examined Decision and open item
[Requirement or supplier capability] [Design review, assessment or document] [Authorized conclusion and action]

Factory and site acceptance testing

Acceptance activity Scope and protocol Result reference and gaps
[FAT or SAT where applicable] [System, configuration, prerequisites and approved protocol] [Executed report, deviations and decision]

Installation qualification

Repeatable qualification protocol

Use this module for IQ, then copy it under OQ or PQ with the stage-specific conditions. Do not split one test case across records. | Protocol setup | Complete before execution | |---|---| | Protocol ID objective and scope | [Stage, system/subsystem and test group] | | Configuration and prerequisites | [Hardware/software versions, prior stage, approved procedures and trained roles] | | Instruments and materials | [Instrument IDs, calibration status, materials and traceability] | | Conditions and sampling rationale | [Ranges, worst-case conditions, sample size and approved rationale] | | Recording and deviation method | [Raw-data location, evaluation method and deviation route] |

Test ID and requirement Test step Expected result and acceptance criterion
[Test ID; URS/risk ID] [One executable action with exact setpoint and units] [Observable result and approved criterion]
[Test ID] [Next action] [Expected result and criterion]

Execution record

Test ID Actual result and raw data Outcome and execution record
[ID] [Leave unexecuted until performed; record values and units] [Pass/Fail only after evaluation; executor and date]
[ID] [Raw-data reference and observation] [Outcome or deviation ID]
Stage report Executed scope deviations and decision
IQ report reference [Executed/not executed tests, results, deviations, conclusion and authorization to proceed]

Operational qualification

Copy the protocol and execution module above. Define operating ranges and challenge conditions before execution. | OQ planning and report | Controlled record | |---|---| | Functions and operating limits challenged | [Test IDs, ranges, alarms, interlocks and approved criteria] | | Coverage and prerequisites | [Prior-stage status, instruments and test conditions] | | Executed result and conclusion | [Raw data, deviations, report and authorized next-stage decision] |

Performance qualification

Copy the protocol and execution module for representative operation, process performance, cleaning or utilities as applicable. | PQ planning and report | Controlled record | |---|---| | Routine conditions and sampling | [Materials, personnel, runs, sampling rationale and approved criteria] | | Critical parameters and attributes | [CPP/CQA IDs, limits, units and evidence] | | Executed result and conclusion | [Data, variation, deviations and report; no assumed release] |

Deviations and traceability

Deviation and affected test Assessment and correction Closure evidence and decision
[ID, observation and test ID] [Impact, cause, action and retest rationale] [Evidence, reviewer and status]
Requirement and risk Test or evidence Result and unresolved gap
[URS/risk ID] [Protocol, test and report] [Recorded outcome and open item]

Validation summary report

Summary question Recorded conclusion and evidence
What was executed [Stages, protocol versions, configurations and omitted tests with reasons]
Were acceptance criteria met [Result summary, deviations and evidence; do not infer pass]
What remains open [Conditions, risks, restrictions, owner and target date]
Is progression or release authorized [Decision, authority, approval reference and operating boundary]

Maintaining the validated state

Controlled activity Adopted rule and trigger Evidence and responsibility
Change control [Impact assessment, approval and requalification criteria] [Change record and authority]
Periodic review or verification [Frequency, inputs, method and criteria] [Review result and actions]
Operation cleaning and maintenance [Qualified ranges, procedure and competence] [Logs, exceptions and review]

Glossary

Term Meaning in this package Source
[URS IQ OQ PQ or other term] [Expansion and adopted meaning] [Controlled reference]

Package completeness check

  • [ ] Protocols and criteria were approved before execution and raw data is traceable.
  • [ ] Actual results, deviations and decisions are recorded without prefilled outcomes.
  • [ ] Traceability, open items and qualified operating limits are reviewed before release. | Review role | Date and decision | Signature or approval record | |---|---|---| | [Engineering, validation or quality authority] | [Approved or returned] | [Controlled reference and conditions] |
Build from your source material

Create your validation package (iq/oq/pq) in Docsie

Bring your recordings and select this template. Docsie organizes supported material into chapters and task articles for your team to review.

Create in Docsie Browse all templates

Downloads are editable blank templates. Review generated content against your source material before use.

More long-form templates

Compliance Program Manual

Compliance program manual built on the elements of an effective program: governance, risk, policies, reporting, review.

Learn More

Documentation Style Guide

House rules for voice, grammar, formatting, UI and code text, and terminology that keep documentation consistent.

Learn More

Information Security Policy Set

Top-level security policy plus topic-specific policies grouped by control theme, aligned to ISO/IEC 27002.

Learn More