Intended use and risk
Clarify users, functions, records, interfaces, system boundaries, and the consequences of failure.
Reviewable outcome: An intended-use and risk assessment with a proposed assurance approach.
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Computerized systems and data integrity
Make the system’s intended use and evidence understandable.
We help teams define what a computerized system must do, which records and decisions depend on it, and what evidence and controls support its use.
When to bring us in
Start with the uncertainty holding up the next decision.
- A laboratory, manufacturing, infrastructure, or quality system needs a proportionate validation strategy.
- Legacy records, supplier evidence, access controls, or system changes leave uncertainty about the current state.
- A project needs independent review of requirements, test evidence, traceability, or data-integrity gaps.
Consulting scope
Work we can structure with your team.
The following are possible engagement components. The agreed scope determines the deliverables.
Validation and evidence review
Connect requirements, supplier evidence, proposed tests, actual results, and unresolved deviations.
Reviewable outcome: A traceable evidence-gap review and recommendations for client authorization.
Lifecycle and remediation
Review ownership, change control, access, record retention, periodic review, and incident or deviation handling.
Reviewable outcome: Prioritized control requirements and a practical remediation roadmap.
Getting started
What we would review.
The intended use, system inventory and architecture, requirements, supplier documentation, configuration details, existing test records, procedures, and known issues.
Begin with a high-level inquiry. Confidential records can be shared after suitable arrangements are established.
Scope and decisions
The approach depends on the system, product, jurisdiction, and intended use. Drug GMP computerized systems and medical-device software assurance are not treated as interchangeable scopes. AI-enabled workflows also need evaluation of AI behavior and human review.
Client Quality retains protocol authorization, approval, and release decisions. Specialist roles, timing, and deliverables are agreed before the work begins.