The "Validation" Barrier: Generic maintenance tools often fail in Pharma because they lack 21 CFR Part 11 compliance (Digital Signatures & Audit Trails).
The "Calibration" Link: Your CMMS must handle calibration tolerances as strictly as it handles repairs.
The Top Contenders: We review Fabrico, Blue Mountain, MasterControl, and others to find the best fit for GMP (Good Manufacturing Practice) environments.
Maintenance in the Pharmaceutical industry is not just about keeping machines running. It is about proving—with absolute certainty—that the machine ran within validated parameters.
If a tablet press stops, it costs money. But if the press runs out of calibration and you don't have a digital record of the fix, you risk a Form 483 from the FDA or a non-conformance from the EMA.
Most "easy-to-use" CMMS tools (like UpKeep or Limble) struggle here.
They allow users to delete records or edit history without a trace, which is a compliance nightmare.
If you need software that balances Usability with Data Integrity (ALCOA+), here are the 5 best CMMS options for Pharma in 2025.
Best For: Manufacturers who need GMP compliance without the "Enterprise" complexity.
Fabrico bridges the gap between modern usability and strict compliance. It is designed to be validated quickly, allowing you to modernize your maintenance without a 12-month implementation project.
21 CFR Part 11 Ready: Fabrico supports Digital Signatures and Immutable Audit Trails. Every change to a record (who, when, what) is logged and cannot be deleted.
Integrated Calibration: Unlike general tools, Fabrico handles quantitative calibration checks. You can set Min/Max tolerances for sensors. If a reading is out of spec, the system flags it immediately.
OEE for Pharma: Fabrico tracks OEE Quality in real-time. If the reject rate on a blister line spikes, the system triggers a maintenance check, helping you save high-value batches.
Digital Logbooks: Replace your paper cleanroom logs with tablets. Fabrico acts as a "Digital Logbook" for equipment status, ensuring ensuring "Status Labels" (Clean / In Use / Dirty) are tracked digitally.
The Verdict: If you want to pass your audit without fighting clunky software, Fabrico is the modern choice.
Best For: Dedicated Regulatory Asset Management.
Blue Mountain is the industry veteran. It is designed exclusively for Life Sciences (Biotech, Pharma, Med Device).
Pros: It is the gold standard for validation. It comes with pre-validated templates that speed up the IQ/OQ/PQ process. It handles calibration standards hierarchy perfectly.
Cons: It is heavy. The interface feels like a database, not an app. Technicians often find it slow and difficult to navigate for simple mechanical repairs.
The Difference: Blue Mountain is for the Quality Department; Fabrico is for the Maintenance Team (with Quality oversight).
Best For: Quality Management System (QMS) integration.
MasterControl is primarily a QMS (handling CAPA, Change Control, Documents) that also offers equipment calibration and maintenance features.
Pros: Total integration with your quality system. If a maintenance event triggers a CAPA (Corrective Action), it happens in one ecosystem.
Cons: The maintenance module is secondary to the quality module. It lacks the deep operational features (Spare Parts Optimization, OEE, shift handovers) that a dedicated maintenance platform offers.
The Difference: Use MasterControl for documents; use Fabrico for machines.
Best For: Large Pharma conglomerates.
If you are a Pfizer or a GSK, you likely run SAP.
Pros: Global standardization. It integrates maintenance costs directly with the general ledger and supply chain.
Cons: Usability. SAP PM is notoriously difficult for shop-floor technicians. This leads to "Shadow Systems" (paper logs) which create compliance risks during audits.
The Difference: SAP is the financial system of record; Fabrico is the operational system of record (integrated with SAP).
For smaller contract manufacturers (CMOs), heavy tools are too expensive.
Some smaller labs try to use Limble or MaintainX.
Warning: While these tools are great for general industry, be very careful with Data Integrity. Ensure they offer a specific "21 CFR Part 11" module before buying, or you will fail your validation audit. Fabrico offers this natively while maintaining the ease of use of these lighter tools.
| Feature | Fabrico | Blue Mountain | MasterControl | SAP PM |
| Primary Focus | Maintenance & OEE | Calibration/Asset | Quality (QMS) | Finance/ERP |
| 21 CFR Part 11 | ✅ Native | ✅ Native | ✅ Native | ✅ Native |
| User Experience | Modern | Complex | Complex | Complex |
| Calibration | ✅ Integrated | ✅ Advanced | ✅ Basic | ✅ Basic |
| Setup Speed | Fast | Slow | Slow | Slow |
In the past, Pharma companies had to buy ugly, difficult software to stay compliant.
In 2026, you don't have to choose.
Stick with Blue Mountain if: You are running a pure Metrology Lab.
Choose SAP if: You are mandated by Corporate IT.
Choose Fabrico if: You want a system that technicians actually like using, which ensures the data is entered correctly the first time. Good data is the best defense against an auditor.
Modernize your GMP maintenance.
Book a Demo with Fabrico to see our audit-ready workflows in action.
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