GMP & ISO READINESS SCORECARDS FOR PHARMA, MEDICAL DEVICE & BIOTECH COMPANIES
Not sure where your compliance gaps are? Choose the scorecard that matches where you are — GMP licensing and ISO accreditation, a TGA GMP inspection, an ISO 13485 audit, or your transition from R&D into clinical trial manufacturing — and get a clear, practical readiness read in a few minutes.
CLINICAL TRIAL MANUFACTURING READINESS SCORECARD
Moving from R&D into clinical trial manufacturing brings GMP, supplier and sponsor compliance risk most teams don't see coming. Our free scorecard uncovers your gaps in GMP readiness, supplier oversight and phase-appropriate PQS — before they become a regulatory issue or a delayed trial.
GMP LICENSING AND ISO ACCREDITATION READINESS SCORECARD
Millions spent on fit-out and equipment doesn't guarantee a pass. Our free scorecard checks whether your PQS/QMS, facility and documentation are genuinely ready for GMP licensing or ISO 13485/17025/9001 accreditation — surfacing the gaps that typically emerge during inspection, before you submit your inspection.
GMP PHARMACEUTICAL REGULATORY INSPECTION READINESS SCORECARD
Many sites think they're ready — until inspectors arrive. Our free 20-question scorecard benchmarks your PQS, validation, processes and data integrity systems against PIC/S PE009-17, so you can close gaps before your next TGA inspection.
ISO 13485 MEDICAL DEVICE NOTIFIED BODY INSPECTION READINESS SCORECARD
Seeking initial ISO 13485 certification, or facing a surveillance audit? Our free 20-question scorecard checks your QMS, design and development, risk management and processes against ISO 13485:2016 — so you know where you stand before your Notified Body auditor does.
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