By Mainpac | Built for Compliance. Trusted by Industry.
Still relying on legacy systems, paper logs, or disconnected tools to manage GMP-critical assets? In 2025, your outdated GMP maintenance system could quietly become your biggest compliance risk.
In tightly regulated industries like pharmaceuticals, biotech, and biomedical manufacturing, the mindset of “if it ain’t broke, don’t fix it” no longer holds. What once passed internal checks can now lead to costly observations, halted production or worse, product recalls that impact patients.
Over the years, we’ve seen many operations that follow general manufacturing practices rely on processes that seem to work—until they don’t. Spreadsheets that miss version tracking. Legacy systems are no longer supported. Site-to-site variation that raises red flags with auditors. These issues don’t always scream, they whisper. But the consequences? Loud and expensive.
This article breaks down the hidden costs of outdated GMP maintenance systems—and shows why leading pharma and biotech teams are making the smart shift to future-ready, audit-proof solutions in 2025.
1. “Good Enough” Isn’t Passing Audits Anymore
Spreadsheets, tribal knowledge, and outdated CMMS software are still the norm in many regulated facilities. They’re quick. They’re familiar. And on the surface, they seem to get the job done.
But regulators now expect more and they’re looking deeper.
A missing calibration record. A forgotten work order. A handwritten log that can’t be verified.
These seemingly small gaps often lead to:
- FDA 483 observations
- EU Annex 11 non-compliance
- CAPA delays and production holds
Hidden Cost: Rework, wasted batch production, inspection delays, and audit escalation.
Better Way: Switch to a validated, centralised EAM system with audit trails, automated alerts, and secure asset histories. Mainpac’s platform is built for 21 CFR Part 11, GxP, and TGA compliance—so you’re always inspection-ready.
2. Manual Calibration Tracking = Compliance Minefield
In life sciences, missing a calibration doesn’t just mean rescheduling, it can mean regulatory violations, rejected product, and increased audit attention.
Yet many teams still track calibrations using:
- Excel files buried in folders
- Sticky notes and whiteboards
- Email chains between departments
This manual approach creates risk and it’s often invisible until it’s too late.
Hidden Cost: Failed audits, rejected batches, unplanned downtime, and potential product recalls.
Better Way: Automate calibration scheduling, tracking, and documentation within your GMP maintenance system. Mainpac’s calibration module is GxP-friendly and ensures full traceability for every critical asset.
3. Inconsistent Documentation Across Sites
One plant uses Google Sheets. Another still logs data in paper binders. A third relies on a legacy CMMS that no longer updates. Sound familiar?
This site-by-site variation makes it incredibly hard to demonstrate control especially during centralised audits or multi-site inspections.
Hidden Cost: Incomplete records, slower CAPA implementation, internal confusion, and increased risk of non-compliance.
Better Way: Standardise your documentation workflows across all locations. Mainpac supports both SaaS and on-prem deployments, helping teams stay aligned regardless of geography or infrastructure.
4. Reactive Maintenance = Shorter Lifecycles & Lost Production
Fixing assets only after they fail might seem like a cost-saving move. But in GMP-regulated environments, it’s often a false economy.
Without visibility into early failure signs, you’re always one step behind—and one step away from:
- Line stoppages
- Cold-chain failures
- Uncontrolled deviations
- Technician scramble during audits
Hidden Cost: Emergency repair fees, lost production time, reduced asset lifespan, and risk to product integrity.
Better Way: Move from reactive to predictive maintenance. Mainpac uses condition data, asset history, and trend analysis to help you take action before problems become critical.
5. You Can’t Improve What You Can’t See
The most dangerous gaps in your GMP maintenance system are the ones you don’t even know exist.
Without real-time visibility across facilities, assets, and maintenance history, your team can’t:
- Prioritise based on risk
- Identify compliance blind spots
- Justify decisions during inspections
Hidden Cost: Missed warnings, duplicated effort, and audit findings you didn’t see coming.
Better Way: Mainpac unifies your maintenance data into a single, audit-ready dashboard—helping you make informed, risk-based decisions and demonstrate control with confidence.
If you’re navigating these challenges, it may be time to re-evaluate your asset maintenance approach especially in GMP-regulated environments where traceability and accountability are non-negotiable.
Frustrated by unreliable maintenance systems? Let’s help you regain control and compliance. Contact the Mainpac team to start the conversation.
ALCOA+ and Smarter Compliance with Reliability Centred Maintenance
The ALCOA+ principles guide how data should be managed in GMP environments:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Complete, Consistent, Enduring, and Available
But following ALCOA+ isn’t just about recordkeeping. It requires a proactive, systems-driven approach that’s fully aligned with reliability centred maintenance practices.
Mainpac supports ALCOA+ by enabling accurate, timely, and standardised maintenance documentation across assets and facilities. You can’t apply ALCOA+ effectively without the right tools and that’s exactly what Mainpac delivers.
Real-World Scenario (Shortened)
A global biotech firm missed one calibration after a spreadsheet version was overwritten.
The result? A failed audit, $320k in lost product, and three weeks of production downtime.
Today, they rely on Mainpac for automated calibration tracking and audit-ready compliance.
Why 2025 Demands a New Standard
Audit expectations are evolving fast. Regulators are tightening documentation requirements. And the margin for error is disappearing.
What worked five years ago is now seen as a vulnerability. And “good enough” is often the weak link that brings everything else down.
We’ve seen the shift:
- Audits are more rigorous
- Follow-ups are less forgiving
- Teams relying on outdated tools are under pressure
That’s why leading teams, like Phebra and Blackmores aren’t waiting for a crisis to modernise. They’ve already upgraded to validated, compliant, and scalable systems with Mainpac—future-proofing their operations against regulatory pressure and internal inefficiencies.
In this environment, you don’t just need a better maintenance tool: you need a smarter, more strategic system.
The Cost of “Later” Is Rising
Every audit, every production cycle, and every missed calibration adds up.
The choice isn’t whether to modernise your GMP maintenance system—it’s whether to do it now, or after a compliance issue forces your hand.
Book your GMP Maintenance Health Check today
The GMP Maintenance Health Check is built into the Mainpac EAM system—helping pharma and biotech teams identify compliance risks, streamline maintenance, and stay audit-ready.
Start your free trial or book a demo today to see how Mainpac supports GMP standards from the ground up.
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
What is GMP in maintenance?
GMP (Good Manufacturing Practices) in maintenance refers to ensuring that all maintenance activities, records, and systems meet regulatory standards to ensure consistent product quality and patient safety.
What is ALCOA+?
ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate—and Complete, Consistent, Enduring, Available. It’s a data integrity framework used in GMP environments to ensure audit-proof recordkeeping.
How does EAM software support compliance?
EAM software like Mainpac supports GMP compliance through automated maintenance scheduling, calibration tracking, centralised documentation, audit trails, and real-time insights across assets and facilities.
