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Validation

5 tools, 4 guides, 1 comparison

Validation answers § 11.10(a): the system does what you need it to do, and you can show that it does. These pages size that work for a small lab rather than a large pharmaceutical site.

Read the CSV lifecycle, what FDA's computer software assurance guidance changes, and where GAMP 5's categories fit, then generate the plan, the requirements, the protocols and the trace as editable templates.

Chromolithograph of an analytical balance and a pH meter on a bench with a validation binder in frontFig. 01
An analytical balance and a pH meter on the bench, with the validation binder in front.

Tools

Every tool
Validation, plannerCSA validation scope plannerPlan computer software assurance feature by feature, FDA's way: intended use, high or not high process risk, the testing that fits, the record to keep.OpenValidation, templateValidation master plan templateGenerate a validation master plan for a small lab: scope, systems inventory, responsibilities, approach, schedule and a signed approval block.OpenValidation, templateIQ OQ PQ templateFree IQ OQ PQ protocol template for a computerized system: test steps, expected vs actual, Pass or Fail, deviations and a signed summary report.OpenValidation, templateTraceability matrix templateFree requirements traceability matrix template for GxP validation: trace each URS line to its spec, test and result, flag the gaps, copy as CSV.OpenValidation, templateURS template (user requirement specification)Free URS template for buying GxP software: intended use, numbered requirements with priority and risk, a one-click Part 11 baseline, CSV and print.Open

Comparisons

Every comparison
Validation, 6 vendors readComputer system validation software (paperless validation)Computer system validation software compared: paperless validation tools on e-signed execution, traceability, CSA testing and Part 11.Read the comparison

Guides

Every guide
  • Computer system validation (CSV) for small labs

    The CSV lifecycle sized for a small lab: requirements, risk, IQ, OQ and PQ, the report and periodic review, and what goes in the pack.

    17 min read
  • CSA vs CSV: what changed

    CSA vs CSV side by side: what FDA's 2026 CSA guidance changes, what it leaves alone, and one quality system planned both ways.

    12 min read
  • What is GAMP 5?

    GAMP 5 in plain words: what ISPE's guide is for, its life cycle, the software categories by name, and how it sits with Part 11, CSA and Annex 11.

    15 min read
  • Excel spreadsheets under Part 11

    When an Excel spreadsheet can hold GxP data under Part 11, the controls it needs, and when to move the calculation into a system.

    14 min read