Organizations pursue ISO certification when the real issue is validation evidence. They overhaul their QMS when the problem is specific and fixable. They invest in new tools when the gap is process documentation. Without independent assessment, you solve the wrong problem — expensively. Prior assessments may have identified gaps, but generic compliance checklists without effort estimates or implementation sequencing don't tell you what to do Monday morning.
You're moving from SMB to enterprise pharma clients and need to demonstrate quality maturity for vendor qualification reviews and RFP responses
You have findings from regulatory inspections or client audits and need a clear remediation path with realistic effort estimates
Before committing to ISO certification, new QMS platforms, or validation overhauls — verify you're solving the right problem
You need to understand your governance and validation readiness before deploying AI capabilities in regulated workflows
Document control, CAPA, change control, training, internal audit — evaluated against your target market's expectations, not abstract standards
SDLC practices, CSV methodology, requirements traceability, and evidence quality for current and planned systems
21 CFR Part 11, EU Annex 11, GxP requirements, HIPAA, GDPR — scoped to your actual regulatory obligations
Access controls, encryption, cloud architecture, business continuity — assessed against SOC 2, ISO 27001, and client expectations
Architecture review, risk classification, intended use definition, human oversight, audit trail coverage for AI-generated outputs
Vendor qualification status, cybersecurity posture, contract management, and ongoing oversight processes
Gap Analysis Report: Verified observations with supporting evidence, regulatory and standard references, severity classification (Critical/High/Medium), and risk type (regulatory, commercial, operational). Prior findings are tracked with remediation status so you can see progress, not just current state.
Action Plan (Primary Deliverable): Executable tasks with level of effort estimates, calendar duration, dependencies, resource requirements, and priority sequencing. Organized into phases aligned with your business objectives — whether that’s market tier progression, audit preparation, or certification readiness. This is a planning framework, not a compliance checklist.
Summary Session: Working session to walk through deliverables, discuss priorities, and calibrate recommendations to your operational reality.
The assessment and action plan are yours regardless of next steps. You decide whether to execute internally, engage another firm, or bring us in for implementation.
Start with a consultation to scope your assessment — no predetermined answers
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