Stop scrambling through paper binders when the inspector arrives. The CLEEN Audit Portal stores every cleaning event, analytical result, and equipment release in a searchable database with 21 CFR Part 11 audit trails — so any record is retrievable in seconds, not hours.
Key Highlights
Regulatory Context
The firm was unable to produce cleaning validation records on request. Documentation was stored across disconnected systems and paper files. Retrieval took over four hours and key documents were missing entirely.
Cleaning validation documentation did not link procedures performed to test results or equipment release decisions. The firm could not reconstruct cleaning history for specific equipment during the inspection period.
Cleaning validation calculations were maintained in spreadsheets without access controls or electronic signatures. Multiple versions existed with different results. The firm could not determine which was the approved calculation.
Cleaning records for shared equipment were incomplete. Some changeovers were documented, others were not. No centralised system ensured every cleaning event was recorded.
When cleaning failed acceptance criteria, no traceable link existed between the OOS result, investigation, CAPA, re-cleaning, and verification. Deviation-to-CAPA documentation was scattered across multiple systems.
The Problem
Audit Readiness in Leucine CLEEN
Every cleaning event, validation study, and analytical result stored in a searchable database. Query by equipment, product, date, operator, or status. Answers inspector questions in seconds.
Record Sources
Audit Portal
Output
Complete electronic trail for every record. Who created it, who modified it, when, why, and the before/after values — all with electronic signatures. Meets ALCOA+ requirements.
One-click generation: cleaning summary per equipment, trend analysis, OOS with CAPAs, equipment status, worst-case matrices. Formatted to match inspector expectations.
Live dashboard: clean, dirty, in-process, on-hold, or released — for every piece of equipment across all sites.
Complete chain in one view: OOS → deviation → CAPA → re-cleaning → verification → closure. No broken links.
The Solution
Purpose-built audit readiness for cleaning validation — addressing both documentation gaps and operational inefficiency.
Every cleaning record in a searchable database. Pre-built reports generated in one click in formats inspectors expect.
Electronic signatures, audit trails with before/after values, role-based access, and record retention. Every action logged and attributable — meeting ALCOA+ requirements.
Monitor cleaning validation 483s and warning letters across the industry. Know what inspectors are citing before they arrive at your facility.
Before & After
Results
Real results from manufacturers using the CLEEN Audit Portal.
Next Step
Stop failing audits because of disorganised documentation. CLEEN's Audit Portal gives you instant access to every cleaning record, compliant audit trails, and pre-built inspector reports.
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