GxP Cleaning Validation · Pharma 4.0
CLEEN is an on-premise cleaning validation system for pharmaceutical manufacturing — deterministic MACO limits, Maker-Checker approvals, 21 CFR Part 11 electronic signatures and a complete audit trail in one platform.
If your limits live in spreadsheets and your protocols live in binders, every batch release carries risk you can't see.
MACO calculations maintained by hand: unvalidated formulas, silent rounding, copy-paste versions that nobody can trace back to a source.
Every manual transcription between lab, QA and production is a chance for a data-integrity finding — discovered by an inspector instead of by your system.
Days spent reconstructing who calculated what, who approved it and why — evidence assembled for the inspection instead of generated by the work itself.
CLEEN digitizes the cleaning validation lifecycle end to end. This is what the automated process looks like on your production floor.
Step 01
Register facilities, rooms, equipment and equipment trains, products and API substances. Toxicity data — PDE values and daily doses — enters through controlled, versioned revisions, never loose files.
Step 02
A deterministic risk engine scores every product — occupational exposure, solubility, potency, toxicity, cleanability — and selects the worst-case product for each equipment train. The ICH Q9 logic your assessors already apply, made systematic.
Step 03
The MACO engine evaluates toxicity (PDE-based), dosage (1/1000) and 10 ppm criteria, takes the strictest limit, and derives carryover, surface and swab/rinse limits with analytical recovery factored in. Decimal-exact arithmetic, fail-closed on any missing input, every result frozen as an immutable snapshot.
Step 04
Every critical record follows Maker-Checker: drafted, reviewed and approved by different people, sealed with a 21 CFR Part 11 electronic signature that requires re-authentication and binds cryptographically to the exact record signed. Self-approval is impossible by design.
Step 05
Every create, change, approval and signature lands in one atomic audit trail — who, when, from where, and why. When the inspector asks, the evidence is a query, not a project.
Pharma 4.0 asks for digital maturity and data integrity by design. Here is what that means for your operation.
The hours your validation team spends building, cross-checking and re-approving spreadsheets collapse into a calculated, pre-approved digital workflow. Fewer deviations, fewer repeat validations, faster introduction of new products and equipment.
There is no manual transcription to get wrong. Calculations run on checked, decimal-exact arithmetic that refuses to output a number when an input is missing or invalid — the system fails closed, never silently.
Audit trails, signature manifests and immutable calculation snapshots are generated by the work itself. Audit preparation becomes retrieval, not reconstruction — walk into any inspection with evidence, not explanations.
Multi-site isolation keeps every site's records sovereign while master data stays shared. Role-based workflows with enforced segregation of duties route each task to the right person — and only the right person.
Engineering choices you can defend to your own IT and QA — no shortcuts.
Memory-safe systems language; deterministic, decimal-precise computation.
Proven relational integrity; attributability enforced at the schema level.
Runs inside your perimeter. Your data never leaves your site.
Five security layers from TLS to domain rules; hardened authentication.
A typed, contract-first API surface, ready for your integrations.
OpenTelemetry tracing and business metrics out of the box.
Where the industry is heading
Cleaning validation should stop being a document defended once a year and become a living, continuously-proven digital truth — where every site, every equipment train and every batch carries its own evidence, and nothing from one product ever crosses into the next patient's medicine.
Reactive → Predictive
Instead of proving cleanliness after the fact, manufacturers anticipate residue risk before a batch is ever made.
Data islands → Connected plant
A single connected record across sites, equipment and products — real Pharma 4.0 maturity in place of disconnected spreadsheets.
Manual work → AI validation engineer
cleen grows from a system of record into a copilot that drafts, checks and reasons about validation — with a qualified human signature always in command.
We build in the open with our customers. These capabilities are in development — shown here as roadmap, not as shipped features.
Multi-step validation protocols with sampling plans, acceptance criteria and step-by-step execution logs — closing the loop from calculated limit to batch release.
Explainable risk rationale, protocol drafting, root-cause and CAPA assistance, audit-trail integrity monitoring — a phased path from AI copilot toward autonomous validation, with a human signature always in charge.
To turn cleaning validation from a paper burden into provable digital truth — so pharmaceutical teams spend their time protecting patients, not defending paperwork.
Every number traceable to its inputs, every record to its author, every approval to a signature. If it's in cleen, you can stand behind it.
Compliance is not the goal — it is the floor. The goal is that nothing from the previous batch ever reaches the next patient.
A focused demo with your equipment train, your worst-case product and your limits — not a canned slideshow.
Request a DemoOn-premise pilot · Your data stays on your site