What we succeed?
As a result of the partnership we established with Validfor, our test cycles shrink from weeks to daysthrough one structured digital workflow and standardized workflows and centralized validation knowledge
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The Problem
Legacy QMS Infrastructure Unable to Meet Modern GxP Requirements
A global pharma manufacturer replaces a legacy on-prem QMS with a multi-tenant SaaS eQMS supporting deviations, CAPA, change controls, training records, and audit readiness.
High DI risk — records drive product quality decisions
Medium-high security risk across the platform
Medium change velocity due to weekly SaaS releases
No validated audit trail or e-signature coverage in legacy system
The Strategy
Risk-Based Validation Across GxP-Critical Workflows
We implemented a risk-based validation approach scoped to GxP-critical workflows, covering electronic record retention, audit trails, e-signatures, and integrations with identity provider and document management.
Given high data integrity risk and medium change velocity from weekly SaaS releases, risk-based validation and periodic evaluation were treated as essential — not optional.
Scripted tests for deviation, CAPA, and change workflows and permissions
Audit trail tests: create/modify/close records with reason-for-change capture
Backup/retention: supplier evidence and retrieval tests
Quarterly SaaS release review and annual periodic evaluation
An indispensable tool for managing the software validation life cycle. Comprehensive and structured, ensuring compliance throughout every phase.
Principal Validation Consultant
30+ Years Experience
The Solution
Audit-Ready eQMS with Enforced Data Integrity Controls
The validated eQMS ensures that every GMP-relevant action is fully traceable, access is governed by role-based controls, and complete record sets can be produced for regulatory inspection within defined SLAs — eliminating the audit readiness gaps of the legacy system.
Every GMP-relevant record change generates an audit trail entry showing who/when/what/why
Role-based access prevents unauthorized edits to approved records; access changes logged
System can produce complete, readable copies of records for inspection within defined SLA
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