In pharmaceutical and biotech manufacturing, maintenance data has traditionally been treated as an operational necessity—but not always a compliance priority. That’s changing—fast.
Global regulators like the EMA, FDA, and TGA now expect the Enterprise Asset Management or EAM system to uphold the same standards of data integrity as batch records, lab results, and quality assurance systems. Maintenance is no longer separate from compliance—it’s central to it.
The Cost of Poor Maintenance Data Integrity
Regulators continue to spotlight data integrity and traceability as core pillars of GMP—not just in QA, but across maintenance, calibration, and environmental control systems.
Inspection findings increasingly point to weak EAM system as a source of risk. Missing logs, unclear ownership, and legacy platforms unable to deliver audit trails can all result in major observations—even if the actual equipment is performing correctly.
Real-World Scenario: Missing Calibration Records in a Legacy CMMS
A biotech manufacturer using an outdated CMMS failed to log calibration details for a critical piece of sterile manufacturing equipment.
During an inspection, the system could not show:
- Who performed the calibration
- When it was last verified
- What reference standards were used
Despite the equipment passing spec, the absence of traceable records triggered:
- A major observation
- A delayed batch release
- A CAPA requiring review of their maintenance systems
In regulated environments, if it’s not documented—and traceable—it didn’t happen.
Common Data Gaps in Pharma and Biotech Maintenance Operations
Here are four failure points often flagged in GMP audits:
- Paper-based work orders with missing timestamps or illegible entries
- Manually scheduled PMs leading to missed critical tasks
- No unified audit trail between QA and maintenance systems
- Legacy CMMS tools with no real-time access or role-based accountability
These aren’t just inefficiencies—they’re compliance red flags.
How EAM System Must Now Perform Under ALCOA+
GMP regulators apply ALCOA+ principles across all critical data, including maintenance records:
- Attributable – Who completed the task?
- Legible – Is the record clear and readable?
- Contemporaneous – Was it recorded in real time?
- Original – Is this the first, unaltered record?
- Accurate – Is the information complete and validated?
- Plus: Complete, Consistent, Enduring, and Available
Many outdated or manual systems simply can’t deliver on this standard.
How Mainpac’s EAM System Closes the Integrity Gap
Mainpac offers a purpose-built Enterprise Asset Management platform designed to meet the data integrity expectations of GMP-regulated environments.
Key Features Include:
✔ Digital Work Orders with Time & User Attribution
Every task is tracked with technician ID, time stamps, and activity logs.
✔ Automated Calibration & PM Scheduling
Ensure critical maintenance isn’t missed—with rules-based recurring schedules and alerts.
✔ Centralized, Validated Documentation
All logs, records, and asset histories live in one secure source of truth—accessible for audits.
✔ Full Audit Trails & Role-Based Access
Support Annex 11 and 21 CFR Part 11 requirements with secure logins and change controls.
Want to see how Mainpac’s EAM System supports regulatory compliance and operational control? Explore our Features – Mainpac EAM System
Trusted by Industry. Built for Compliance.
Mainpac works with pharma and biotech leaders across APAC to:
- Reduce unplanned downtime
- Improve inspection outcomes
- Eliminate manual, error-prone systems
- Integrate QA and maintenance workflows for unified traceability
Whether you’re scaling production, preparing for inspection, or replacing an outdated CMMS, Mainpac’s software EAM system gives you the visibility and control regulators now expect.
Strengthen Your GMP Compliance
Mainpac helps maintenance teams strengthen GMP compliance, drawing on real-world audit findings and proven results with other customers. Our approach can assist benchmark your current practices against regulatory requirements and highlight key areas for improvement.
Start your free trial or book a demo today to see how your current systems compare—and how to close the gap.
For more information, visit www.mainpac.com, call us on 02 8404 8800, or email info@mainpac.com—we’re here to help.
Frequently Asked Questions
Q: What makes an EAM system different from a CMMS?
A CMMS typically handles basic work orders and scheduling. An EAM system goes further—managing the full asset lifecycle, audit trails, calibration records, and integration with other business systems.
Q: Can an EAM platform help during inspections?
Yes. With digital records, audit trails, and access logs available instantly, you save time during inspections and reduce the risk of findings.
Q: What’s the role of ALCOA+ in maintenance?
ALCOA+ ensures that asset records are Attributable, Legible, Contemporaneous, Original, and Accurate—with added principles like Complete, Consistent, Enduring, and Available. EAM systems enforce these principles through automated logging and validation.
Q: Is it hard to implement an EAM system in a pharma facility?
With the right vendor and phased approach, EAM implementation can be smooth. Mainpac supports validation-ready deployment tailored to your team, systems, and documentation needs.
