Lumiform Mobile audits & inspections
Get App Get App

Process Validation Report Template

Validation managers in the pharmaceutical industry use such a template for process validation to document everything properly. In this way, they ensure that the regulations are adhered to. This process validation report template is designed to make it easier for validation managers to perform equipment testing and risk assessment, compare acceptance criteria with performance test results, and define ranges of variation.
Rated 5/5 stars on Capterra

Say goodbye to paper checklists!

Lumiform enables you to conduct digital inspections via app easier than ever before
  • Cut inspection time by 50%
  • Uncover more issues and solve them 4x faster
  • Select from over 5,000 expert-proofed templates

Digitalize this paper form now

Register for free on and conduct inspections via our mobile app

  • Cut inspection time by 50%
  • Uncover more issues and solve them 4x faster
  • Select from over 4000 expert-proofed templates
Rated 5/5 stars on Capterra

Process Validation Report Template

Process Validation Report Template

Directions: 1. Identify the influence of each tool on the product 2. Define its corresponding risk priority and attach suitable photos. 3. Define qualification protocol such as environmental demands, utility supply, SOPs ready, calibration devices, acceptance criteria vs. performance test results, and fields of variation. 4. Describe conclusions on the efficacy of the devices/system 5. Finish this template with digital signatures of the validation manager, head of quality assurance and production officer

Equipment Criticality & Risk Assessment

Mixing Tanks

Raw Material and Consumable Refrigerators and Freezers

Toxic Gas Detectors


Product Transfer Pumps

Unfiltered HVAC System

Dust Extraction


Laminar Flow and Safety Cabinets

Safety Barriers


Emergency Stops

Retort Stands

Product Storage Refrigerators and Freezers

Personal Protection Equipment

Filling Equipment

Production Balances



Fire Suppression Systems

Process Water Generators

Automated Cleaning Equipment

Filtered HVAC Systems

Manual Cleaning Equipment

Qualification Protocol

Method(s) to process confirmation

Environmental demands

Utilities supply

SOPs available

Calibration Equipment

Calibration process

Calibration date and time:




Control/Monitor point

Describe the output

Acceptance Criteria and Performance Test Results

Acceptance criteria

Performance test results


Area(s) of Deviation


Qualification Protocol Results

Results of the validity of the devices/system

Full name & signature of Production Officer:

Full name & signature of Validation Manager:

Full name & signature Head of Quality Assurance:

Share this template:
This template is also available in: