ENTI WINAI-assisted pharmaceutical quality assessment

Compliance analysis report

Procedure_Gestion_Deviations.pdf|Analysis in progress

75 %

Compliance score

Weighted requirement
coverage

Covered = 100% • Partial = 50% • Not identified = 0%

Summary of results

#	Requirement	Status	Criticality
1	Verification of corrective action effectiveness	Partially covered	High
2	CAPA – Root cause identification	Covered	Medium
3	Implementation of corrective actions	Covered	Medium
4	Follow-up and effectiveness check	Partially covered	High
5	Documentation of corrective actions	Covered	Low
6	Periodic review of corrective actions	Partially covered	High
7	Responsibilities and authorities	Covered	Low
8	CAPA indicators and trends	Not identified	High
9	Integration with risk management	Partially covered	Medium
10	Continuous improvement of the quality system	Covered	Low
11	Document revision history	Not identified	Medium
12	Approval before distribution	Covered	Medium
13	Controlled distribution of versions	Covered	Low
14	Withdrawal of obsolete versions	Covered	Medium

ENTI WINAI-assisted pharmaceutical quality assessment

#	Requirement	Status	Criticality
15	Archiving of quality documents	Covered	Low
16	Unique identification of documents	Covered	Low
17	Document review frequency	Partially covered	Medium
18	Management of forms and records	Covered	Low
19	Traceability of changes	Partially covered	Medium
20	Training on applicable procedures	Covered	Medium
21	Control of external documents	Covered	Low
22	Backup and data integrity	Covered	Medium
23	Document access permissions	Not identified	Medium
24	Management review of the document system	Covered	Low

1Formalise the CAPA effectiveness checkDefine the verification method, frequency and responsibilities.
2Strengthen follow-up and effectiveness checksFormalise the effectiveness criteria and require evidence before closure.
3Frame the periodic review of corrective actionsSet a minimum frequency and designate the required participants.