Pharma & Life Sciences
GxP-ready MRO data for 21 CFR Part 11 and Annex 11 environments
Fragmented spare-parts and equipment data is an audit risk in a validated plant. Mōksana turns your MRO records into one clean, canonical, fully-traceable source of truth — standardized, enriched, and governed against a 3M+ SKU knowledge graph, delivered through a validated API.
Built for validated, regulated environments
In pharma, MRO data quality is a compliance problem, not just an efficiency one. Mōksana is designed to support the standards your quality team already answers to.
21 CFR Part 11
Electronic records you can defend in an FDA audit
Every standardization, enrichment, and match decision is captured with an attributable, time-stamped audit trail. Records stay traceable to source, so the MRO master that feeds your CMMS and procurement holds up under Part 11 scrutiny.
EU GMP Annex 11
Validated, governed computerized data
Annex 11 expects accuracy, risk-based controls, and lifecycle governance over computerized systems. Mōksana governs part data continuously against a shared knowledge graph — not a one-off cleanse that drifts out of a validated state between projects.
GxP MRO data
One canonical source across GMP sites
Duplicate part names, missing OEM references, and inconsistent descriptions undermine GxP data integrity (ALCOA+). Mōksana resolves them to a single canonical record, so maintenance, calibration, and spares data reads the same across every validated site.
Mōksana supports your validation and data-integrity obligations as the system of record for MRO master data; it does not replace your own computerized-system validation (CSV) or quality processes.
In delivery — global top-10 pharma
A global top-10 pharmaceutical manufacturer is running a live 3-site proof of concept with Mōksana — standardizing and enriching spare-parts and equipment data across three validated facilities against one shared canonical master.
One-off cleansing vs. a governed data utility
A scoped cleansing project leaves your validated master data to drift the moment it ends. Mōksana keeps it compliant continuously.
| Capability | Project-based cleansing | Data utility (Mōksana) |
|---|---|---|
| Standardizes & enriches existing spare-parts data | ||
| Attributable, time-stamped audit trail per record | ||
| Stays compliant continuously as parts and sites come online | ||
| Delivered through a validated, real-time API | ||
| One integration covers every validated site | ||
| Governed against a shared 3M+ SKU knowledge graph | ||
| Continuous governance, no repeat cleansing-project cost |
Frequently asked questions
How does Mōksana support 21 CFR Part 11 for MRO data?+
Mōksana captures an attributable, time-stamped audit trail for every standardization, enrichment, and match decision and keeps records traceable to source. That gives your quality team the electronic-record controls and traceability they need to defend the MRO master data that feeds CMMS and procurement under 21 CFR Part 11. You remain responsible for your own computerized-system validation and quality procedures.
Is Mōksana aligned with EU GMP Annex 11?+
Yes. Annex 11 expects accuracy, risk-based controls, and lifecycle governance over computerized data. Rather than a one-time cleanse that drifts out of a validated state, Mōksana governs part data continuously against a shared 3M+ SKU knowledge graph, keeping the MRO master consistent and controlled across the system lifecycle.
What is GxP MRO data and why does it matter?+
GxP MRO data is the maintenance, repair, and operations data — spare parts, components, and equipment records — used in GMP/GxP-regulated facilities. Inconsistent descriptions, duplicates, and missing attributes undermine data integrity (ALCOA+) and create audit and downtime risk. Mōksana resolves these records to one canonical, enriched master so the data reads the same across every validated site.
Can Mōksana work across multiple validated pharma sites?+
Yes. One integration extends the canonical MRO master to every site. A global top-10 pharmaceutical manufacturer is currently running a live 3-site proof of concept with Mōksana, standardizing and enriching spare-parts data across three validated facilities against a single shared master.
Make your MRO data audit-ready
Book a GxP data assessment and see how Mōksana turns fragmented spare-parts and equipment data into one clean, canonical, compliant source of truth across every validated site.
Book a GxP data assessment