Define the intended use first
The implementation should start with a clear intended-use statement describing the processes, users, records, decisions and regulatory context the platform will support. This drives requirements, supplier assessment, risk evaluation and validation scope.
Without this step, teams either overvalidate low-risk functions or miss controls that matter to record integrity and approval.
Design the future validation workflow
Map how URS, risk assessments, specifications, protocols, test execution, deviations, traceability and summary reports move through creation, review and approval. Define roles, segregation of duties, status controls, electronic signatures, audit-trail review and record retention.
The digital workflow should remove unnecessary handoffs while preserving the quality unit’s oversight and the evidence required for release.
Validate and pilot the platform
Assess the supplier, define requirements, document configuration, test critical functions and confirm that technical and procedural controls support intended use. A representative pilot exposes usability, role, migration and procedure issues before wider rollout.
Measure preparation time, review cycles, rework, traceability completeness and closure performance against the existing baseline.
Implement with PHARPRO DVS
PHARPRO DVS provides connected builders for common validation lifecycle documents, automatic requirements traceability, controlled review and approval workflows, audit-trail support and AI-assisted drafting subject to human review.
PHARPRO can support process mapping, configuration decisions, onboarding, validation planning, pilot execution and controlled scaling.
Frequently asked questions
Can existing Word and Excel records be migrated?
Yes, but migration should be selective and risk-based. Active records, required metadata and approved history should be assessed before transfer.
Does digital validation eliminate SOPs?
No. Procedures remain necessary to define roles, approved use, review, exceptions, administration, audit-trail review and lifecycle controls.
What is the best first pilot?
Choose a representative but manageable validation project with measurable pain points, engaged users and enough lifecycle coverage to test the future process.
See PHARPRO DVS in action
Explore connected validation documents, requirements traceability, controlled review and AI-assisted drafting with qualified human approval.
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