Annex 1 Compliance Diagnostic
A practical diagnostic across the seven areas most frequently flagged in inspections.
20 questions · 7 sections · Instant results
Important: This diagnostic provides a non-binding, informational assessment only. It does not constitute regulatory advice.
The Seven Areas Covered
Each section maps to a source of deficiency that regulators and FDA warning letters consistently identify.
Contamination Control Strategy (CCS)
Is contamination prevention governed as a system, or managed as a collection of procedures?
Cleanrooms, Isolators & Barrier Technologies
Does your physical environment and barrier strategy hold up under dynamic, operational conditions?
Aseptic Concept & Barrier Technology Justification
Can you defend why your aseptic design choices effectively control contamination risk?
Personnel, Gowning & Aseptic Behaviour
Is aseptic behavior consistently demonstrated, or assumed?
Cleaning & Disinfection
Are your cleaning and disinfection practices designed, validated and governed as part of the CCS?
Utilities & Pharmaceutical Water Systems
Are your utility systems designed, monitored and maintained to the standard Annex 1 now requires?
Process Control, Validation & Data Integrity
Are your processes in a demonstrated state of control, and can you prove it?
How to Use This Diagnostic
Annex 1 remediation is rarely a single project. For most sites, full compliance requires changes across multiple systems, facility, utilities, processes, personnel and documentation, each with its own timeline, dependencies and level of urgency. Without a clear picture of where the gaps are and how they relate to inspection risk, it is difficult to sequence that work effectively.
This diagnostic is designed to give you that picture. Across seven areas that regulators and FDA warning letters consistently identify as the most common sources of deficiency, it helps you assess where your site's contamination control is robust, where gaps exist, and where the exposure to a critical inspection finding is highest.
The goal is not to produce a compliance score, it is to give you a structured basis for deciding where to focus remediation effort first.
For each question, select the option that most honestly reflects where your site stands today, not where you plan to be.
In place and documented
Evidence is available.
Partially in place
Gaps are known but not fully resolved.
Not yet addressed
Potential inspection risk.
Ready to Check Your Site?
Answer 20 questions across seven sections to see where your contamination control is robust and where inspection exposure is highest.