Every Batch Traceable. Every Deviation Documented.
Every Audit Defensible.
Continuous monitoring for pharmaceutical manufacturing — 21 CFR Part 11 audit trails, batch genealogy, environmental monitoring, deviation / CAPA workflows, and serialization-ready records on every line.
One avoided batch rejection ($100,000+ in WIP value) pays for years of monitoring.
Built for GxP Realities
The regulatory work doesn't compress. But the manual, error-prone parts do — replaced by continuous, attributable, audit-ready records.
21 CFR Part 11 audit trail.
Every record carries an immutable timestamped, user-attributed audit trail. Electronic signatures, role-based access, and tamper-evident history meet the predicate-rule expectations.
Batch genealogy, end-to-end.
Every lot ties back to raw materials, equipment, environmental conditions, deviations, and operator actions. Pull a batch record in seconds — same data the regulator would ask for.
Deviation & CAPA workflows.
Deviations captured the moment they happen, with the data that caused them attached automatically. CAPAs flow through investigation, root cause, effectiveness check, and closeout — all e-signed.
Environmental monitoring.
Continuous EMS for temperature, humidity, differential pressure, and particulate counts in ISO Class 5/7/8 areas. Excursion alerts, automatic incident creation, and qualified-system records.
Serialization-ready data.
Lot, batch, and unit-level records reconcile against your serialization system (TraceLink, Movilitas, SAP ATTP). DSCSA / EU FMD compliance gets the upstream evidence it needs.
GxP-designed from day one.
Validation packages (URS, IQ, OQ, PQ templates), risk assessment artifacts, and Annex 11 / Part 11 checklists shipped with the platform. Your QA team starts validation, not from scratch.
Built for QA, Not Marketing.
Your QA team talks in batches, lots, deviations, CAPAs, and out-of-spec investigations. The dashboards and records are organized that way — not as a generic SaaS time-series chart with vendor jargon on top.
Your manufacturing team talks in unit operations, in-process controls, and process parameters. Each PP gets continuous data, each in-process control gets automatic excursion handling, each unit operation gets a clean record per batch.
Your validation team talks in URS, IQ, OQ, PQ, and CSV reports. We ship templates aligned to GAMP 5 Category 4 so validation starts from a known baseline, not from scratch on a generic IT platform.
Common Questions From QA & Validation
Is the platform a validated system?
We supply validation lifecycle artifacts (URS, IQ/OQ/PQ templates, risk assessments aligned to GAMP 5 Category 4) so your QA team can complete validation against your SOPs. We don't claim to be pre-validated for your specific intended use — that's not how validation works.
How does the audit trail meet 21 CFR Part 11?
Every record write is immutable, user-attributed via Clerk identity, time-stamped with NTP-disciplined clocks, and includes the reason for change. Signatures are linked to the user identity and the meaning of the signature. Audit trail data is retained for the configured retention period and can be exported for FDA inspection.
What about Annex 11 (EU GMP)?
Same controls as Part 11 with the additional Annex 11 expectations: business continuity (data resilience via store-and-forward at the edge), supplier qualification documents, and explicit data integrity / ALCOA+ language in our SOPs. Available under MNDA before validation.
Can it run in our Class 7 cleanroom?
Yes. Cleanroom-rated sensors and stainless mounts, with intrinsically-safe / explosion-rated options for solvent areas. Edge gateways live outside the cleanroom on the gray side; only the sensors are in classified space.
How do you separate data per customer / per site?
Hard tenant isolation: every record is filtered by enterprise/site/area in every query, not just by URL. Cross-site data exposure is structurally impossible — not a policy that could be bypassed by a misconfigured query. We have a security review available under MNDA.