Find your gaps before the inspection
AI checks your procedures, deviations and CAPAs against GMP requirements: every gap is justified and traceable.
- Results in minutes
- Every gap sourced
- Human validation
- ✓
15Covered
Requirements fully covered
- −
6Partial
Requirements partially covered
- ✕
3Not found
Requirements not covered
Illustration — sample values
The problem
Document reviews keep your experts reading, not fixing gaps
Before every GMP audit or inspection, quality teams spend hours cross-checking their procedures, deviations and CAPAs against the reference standard. It is long, repetitive work that is hard to trace.
Enti Win automates this cross-check. The goal is not to replace the quality expert, but to save them time so they can focus on the gaps that matter.
How it works
Three steps, from your documents to an action plan
1. Upload your documents
Procedures, deviations, CAPAs… as PDF, Word or Excel files. Your files stay confidential.
2. AI checks the requirements
Every requirement of the standard is checked against your documents, passage by passage.
3. Decide, with evidence
Gaps, evidence and a prioritised action plan: a report your experts only need to validate.
The journey on the platform
A guided journey in 4 steps
From your organisation to the report, users stay in control at every step and validate the detected topics before the analysis.
- 1
Documents
Enter your organisation, then upload your files (PDF, DOCX, XLSX).
- 2
Detected topics
AI identifies the GMP topics covered by your documents. You review them before running the analysis.
- 3
AI analysis
Every requirement of the standard is compared with the content of your documents.
- 4
Report
Covered, partial or missing requirements, with the source excerpt behind each conclusion.
What the AI does during topic detection
Usually 2 to 5 minutes, depending on the number of documents.
- Preparation
- Document extraction
- Visual element analysis
- Consolidation
- Topic detection
The content is then matched against the selected GMP standard.
Supported documents
Your quality documents, as they are
- Deviation management procedure
- CAPA procedure
- Deviation form or template
- Change control procedure
- Approved SOP
- Audit report
- Quality complaint
- APR / PQR report
The report
A clear view of your compliance
Covered
The requirement is fully addressed in your documents.
Partial
The requirement is addressed, but not completely.
Not found
Nothing covers the requirement: a gap to address.
Every result comes with the source excerpt and a prioritised action plan.
Our principles
AI that works for the quality expert
Humans make the call
AI-assisted, never autonomous: the quality expert validates every conclusion.
Justified results
Every conclusion cites the source excerpt from the document concerned.
Confidentiality
Your documents are not reused to train any model.
Traceability
Standard version, timestamps and analysis history are kept.
Who is it for?
Built for the African and Mediterranean pharmaceutical industry
Enti Win is for teams preparing audits, regulatory inspections or periodic document reviews.
- Quality assurance (QA)
- Quality control (QC)
- Regulatory affairs
- Compliance & audit managers
An Industry X.0 solution
Want to try it on one of your documents?
Run your first analysis in minutes. A preview of the result appears right away, and the full report is available online.