Lifecycle playbooks

CSV and CSA Playbooks

Apply the validation lifecycle to SaaS, AI-enabled applications, and spreadsheets without copying the same document set into every project.

Choose the system type

Three validation approaches for common technology

Each playbook identifies the records normally expected in a CSV package and explains how CSA changes the depth and method of testing.

PRACTITIONER METHOD

SaaS Validation and Change Control

A practical route from intended use and supplier evidence to release impact, local testing, and maintenance of the validated state for software you cannot freeze.

  1. Intended Use
  2. Supplier Assessment
  3. Configuration Risk
  4. Data Integrity
Open the Playbook
PRACTITIONER METHOD

Validating AI-Enabled GxP Systems

A controlled path from context of use and human authority to evaluation evidence, release boundaries, monitoring, and stop conditions.

  1. Intended Use
  2. GxP Assessment
  3. Part 11 and Records
  4. AI Role
Open the Playbook
PRACTITIONER METHOD

Spreadsheet Validation and Control

A proportionate method for deciding when a spreadsheet matters and how to control formulas, data, use, change, and retirement.

  1. Intended Use
  2. Complexity
  3. Data Inputs
  4. Calculation Risk
Open the Playbook
Validation lifecycle

From validation planning to periodic review

This crosswalk uses the document names commonly found in validation SOPs. CSA changes how work is scaled and how tests are selected; it does not automatically eliminate familiar CSV deliverables.

  1. 01GxP Assessment & Validation Plan
  2. 02URS & Specifications
  3. 03Functional Risk Assessment
  4. 04Supplier Assessment
  5. 05IQ / OQ / PQ / UAT
  6. 06RTM, Deviations & VSR
  7. 07Release & SOP Readiness
  8. 08Change Control & Periodic Review