GMP Validated Design Document Templates - Open Platform

Lucid GMP Validation Document Kit
Your turnkey suite of ready-to-use templates for rapid CSV compliance

Streamline your computer system validation with Lucid’s pre-built document set, leveraging years of industry best practices to cut weeks off project timelines.

Core Templates

User Requirements Specification (URS)

Functional Requirements Specification (FRS)

System Design Specification (SDS)

Traceability Matrix

Factory Acceptance Test (FAT) Protocol

Site Acceptance Test (SAT) Protocol

Validation Master Plan (VMP)

Document Package

Why Lucid’s Validation Kit?

GAMP 5 Aligned: Each template maps to GAMP Category 3–5 deliverables

Time Savings: Pre-written content slashes authoring time by up to 70 %

Consistent Quality: Standardized format and language for faster peer review

Fully Customizable: Editable Word and Visio files—adapt to your process and naming conventions

Audit-Ready: Includes version control logs, approval workflows, and electronic signature placeholders

How It Works

Download & Customize – Fill in project-specific details in each template.

Review & Approve – Internal or third-party QA review using consistent headings and traceability.

Execute Tests – Run FAT/SAT exactly as written; capture results directly in the documents.

Maintain & Update – Use the VMP’s change-control section to manage future revisions.

Lucid’s Validation Kit gets you to “approved” faster,so you can focus on your product, not paperwork.