Efficiency
Reduce validation cycle time
Complere provides pre-built Validation Master Plan templates, User Requirements Specifications, and test script frameworks so teams do not start from scratch.
Compliance Topic
Validation Approach
A risk-based, lifecycle-oriented path from requirements through IQ/OQ/PQ to ongoing validated state.
Regulated teams purchasing a cloud-based quality system need confidence that the platform was built for validated deployment — and that their team can execute qualification efficiently. Complere supports the full Computer System Validation (CSV) lifecycle, from Validation Master Plan through Installation Qualification, Operational Qualification, and Performance Qualification, using a risk-based approach aligned to GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11.
Key Benefits
How this module improves quality operations, reduces compliance risk, and supports inspection readiness for regulated teams.
Risk-Based
Scope validation to system criticality
Apply GAMP 5 risk classification to determine the right depth of testing — focusing effort on business-critical workflows without over-validating low-risk features.
Lifecycle
Sustain the validated state long-term
Post-go-live changes, patches, and configuration updates flow through controlled change requests that preserve qualification evidence and periodic review records.
Validation package, CSA, and release support
Regulated buyers need more than a slide on “GAMP” — they need clarity on deliverables, testing approach, and what happens when the system changes after go-live.
Deliverables
Typical validation pack
A structured package aligned to your VMP: risk assessment, URS traceability, configuration specification where applicable, IQ/OQ/PQ or equivalent test evidence, deviation handling, and release records — organized for internal QA sign-off and auditor review.
CSA
Computer Software Assurance
Risk-based testing emphasis on intended use and patient/product impact — consistent with modern FDA thinking on CSV/CSA so effort focuses on critical workflows, not low-risk UI noise.
Evidence
Test scripts & release records
Executed test scripts with pass/fail results, evidence attachments, and approvals; release documentation that shows what was qualified and what is in production use.
Lifecycle
Upgrades & periodic review
Controlled assessment of platform updates and configuration changes: impact analysis, re-testing or regression scope, and updated qualification evidence so the validated state is maintained after patches and releases.
Workflow Overview
How Complere supports the workflow
Each step in this workflow is supported by governed records, electronic signatures, and a full audit trail — so quality operations stay traceable and inspection-ready.
01
Validation Master Plan
Agree scope, risk classification, team responsibilities, and validation milestones before configuration begins.
02
User Requirements Specification
Document what the system must do, linked to the business process and compliance obligations it supports.
03
Configuration and Installation Qualification
Configure the system and execute IQ test scripts that confirm the platform is correctly installed in the production environment.
04
Operational and Performance Qualification
Run OQ scripts to verify each function performs as specified, then PQ tests to confirm operational performance under real-world conditions.
Platform Capabilities
The specific controls, features, and workflow functions built into this module to support your quality and compliance objectives.
VMP
Validation Master Plan framework
Define the overall strategy, scope, responsibilities, and acceptance criteria for the validation programme before configuration begins.
URS
User Requirements Specification support
Structured templates capture business requirements, linking each to the test evidence that confirms the system meets the intended purpose.
IQ/OQ/PQ
Installation, Operational, and Performance Qualification
Executed test scripts with pass/fail evidence, deviation notes, and approval signatures at each qualification phase.
Change Control
Validated change after go-live
Configuration changes, upgrades, and new module deployments follow a governed change process that preserves and updates qualification evidence.
Get answers to your CSV and qualification questions before your formal review
Our team works with validation leads, quality directors, and IT partners to scope the qualification package and plan a realistic implementation timeline.