The Hiddden Complexities of Maintaining GMP Compliance
GMP compliance is non-negotiable for manufacturers in industries like pharmaceuticals, food production, and medical devices. It ensures product safety, quality, and consistency.
For many manufacturers, GMP record-keeping is a frustrating maze of spreadsheets, paper logs, and scattered files. Compliance touches multiple departments—tracking contractor certifications, controlling access to restricted areas, maintaining emergency protocols, and ensuring proper shipment handling. When these processes are disconnected, they can lead to errors, inefficiencies, and unnecessary stress during audits.
Data management is a major culprit. 91% of companies struggle with operational issues caused by data quality problems, while nearly half of employees say their company’s filing system is ineffective and disorganized (Source). When compliance documentation isn’t accessible, audits become a scramble, and regulatory risks increase.
Beyond inefficiencies, failing to meet GMP requirements can have serious financial consequences. Companies face potential fines, product recalls, and reputational damage that can be difficult to recover from. (More on GMP non-compliance risks)
Instead of treating GMP compliance as a reactive, box-checking exercise, manufacturers can take a proactive approach with cloud-based software.
5 Smarter Strategies for Maintaining GMP Compliance
1. Make Documentation Effortless with Centralized Record-Keeping
One of the most time-consuming aspects of GMP compliance is documentation. Managing visitor logs, signed GMP agreements, records of induction training on GMP practices, contractor compliance documents, and access control records for visitors and contractors in GMP-controlled areas can quickly become overwhelming. When facility records are scattered across multiple systems or, even worse, stored in physical binders, it can be challenging to stay audit-ready.
Cloud-based facility management software simplifies this process by centralizing all facility operation records in one digital location. It means manufacturers no longer have to waste time searching for files; they can access real-time compliance data in seconds. Additionally, audit trails are automatically maintained, minimizing the risk of missing documentation or outdated records.
Imagine a facility preparing for an unannounced GMP audit. Instead of scrambling to pull training records from one system, visitor logs from another, and shipment receipts from email chains, how simple would it be for the operations team if they could access everything from one centralized platform. With FacilityOS’s modular facility, asset and visitor management platform, captured compliance-related documentation is centrally stored and easily accessible:
- VisitorOS, the visitor management module tracks visitor sign-ins and GMP agreement acknowledgments,
- ContractorOS, the contractor compliance management module maintains up-to-date contractor compliance records,
- EmergencyOS, the emergency and evacuation management module logs safety and evacuation drills and emergency events,
- LogisticsOS, the logistics management module provides a complete digital trail of assets,
- SecurityOS, the physical identity and access management module, tracks visitors who have been granted physical access to GMP-regulated areas.
A connected, cloud-based system like FacilityOS saves time and empowers teams with the confidence that they’re always audit-ready.
2. Control Who Enters GMP-Regulated Areas
Controlling access to sensitive areas within a facility, such as cleanrooms, production zones, and storage facilities, is crucial to GMP compliance. Without a dependable method to enforce access policies, manufacturers face risks of cross-contamination, compliance violations, and security breaches.
A way to streamline this would be to consider a visitor management system that can help verify whether contractors and visitors meet GMP requirements before granting entry. When combined with a physical access control system, companies can automatically validate if an individual has completed the necessary training and certifications before granting physical access to restricted areas.
Consider a scenario where a third-party contractor arrives on-site to perform maintenance near a GMP-regulated production line. Instead of relying on a clipboard sign-in or manually checking their credentials, the facility uses a cloud-based visitor management system integrated with access control.
With FacilityOS, when the contractor checks in, VisitorOS verifies their identity, confirms completion of required GMP training, and captures digital acknowledgment of GMP protocols. SecurityOS leverages rule-based workflows to streamline and automate building access for the contractor to the approved zone—automatically logging the entry for compliance tracking. It’s a seamless process that ensures only qualified personnel enter GMP-sensitive areas without creating extra work for staff.
3. Streamline Contractor Compliance and Visitor Check-Ins Under One System
Manufacturers frequently depend on contractors for specialized tasks, but monitoring their compliance status can be challenging. Are their GMP certifications current? Have they completed the necessary safety training?
One way to simplify this process—especially for EHS managers tasked with overseeing compliance—is to implement contractor compliance management software that centralizes documentation like GMP certifications. This software gives teams a clear, up-to-date view of contractor compliance status and helps ensure that no one without proper credentials enters GMP-controlled areas. It also reduces the administrative burden of manually tracking these requirements across disconnected systems.
Complementing this, a visitor management system adds another layer of control at the entry point. It logs every contractor sign-in, enforces compliance screenings, and can deliver site-specific GMP or safety training during check-in.
Both of these tools are valuable, but here’s the catch: if they don’t integrate, you’re just creating a new set of silos. One system holds compliance records, and the other tracks check-ins—but data can fall through the cracks without a connection. For EHS managers, that means more manual reconciliation and less confidence in the accuracy of compliance tracking.
That’s why it's important to look for solutions that work together out of the box. With FacilityOS, for example, ContractorOS and VisitorOS are designed to sync seamlessly, ensuring contractor compliance data is automatically verified during check-in and every step is logged for a complete, centralized audit trail. It's a more connected approach that helps EHS leaders stay ahead of regulatory requirements while keeping the facility safe and compliant.
4. Modernize Emergency Preparedness for GMP-Regulated Facilities
GMP compliance involves more than production quality; it necessitates a well-documented emergency management plan. Facilities must demonstrate that evacuation procedures are established, drills are regularly conducted, and personnel safety is prioritized. Traditional paper-based or basic spreadsheet emergency response plans can be challenging to update and even more complex to execute during an emergency event.
A fire alarm goes off during a shift change, and several contractors and visitors are on-site. Paper rosters can’t keep up, and spreadsheets aren’t much help in knowing who has evacuated and who’s still inside in real-time. For facilities operating under GMP standards, that uncertainty doesn’t just pose safety risks—it can also put compliance at risk.
A cloud-based emergency management system can make a real difference. For example, in FacilityOS's module EmergencyOS, every stage of the evacuation and emergency response is digitized and logged. EHS and safety teams can digitally track emergency drills, log incidents, and access up-to-date evacuation procedures immediately. During an emergency, the module offers real-time visibility into personnel accountability through digital mustering and roll calls. EmergencyOS’s Emergency Profiles capability enables the creation of multiple custom profiles tailored for different emergency scenarios.
5. Ensure Traceability and Compliance in Shipment Handling
Another critical area of GMP compliance is logistics and asset tracking. From raw material intake to outbound product shipments, manufacturers must ensure that every movement is traceable, documented, and meets defined handling requirements. For industries dealing with temperature-sensitive pharmaceuticals, perishable food products, or regulated medical devices, even minor deviations during transit can pose serious compliance risks.
If a facility is distributing temperature-sensitive pharmaceuticals to multiple sites, the operations or EHS lead isn’t just tracking whether the shipment arrived—they need to confirm that it maintained the correct environmental conditions, that every handoff was documented, and that any deviations were flagged immediately. Without that visibility, even a minor disruption could become a compliance risk.
LogisticsOS, part of the FacilityOS platform, helps close that gap. It gives manufacturers complete visibility into the movement and condition of shipments—from departure to final delivery. Real-time monitoring, automated record-keeping, and proof-of-delivery logs ensure that every product moves through the supply chain safely, efficiently, and fully aligns with GMP regulations.
Make GMP Compliance Work Smarter, Not Harder
GMP compliance is complex because it encompasses many aspects of facility operations, including training, documentation, visitor access, contractor oversight, emergency preparedness, and logistics. Managing these areas in isolation often leads to gaps, missed updates, and added pressure during audits.
Connecting these components through a unified, cloud-based system is a more effective approach. By integrating compliance tools, from sign-ins and certifications to drills and shipment tracking, facilities can streamline processes, reduce manual work, and enhance visibility overall.
This shift benefits the teams responsible for ensuring compliance daily while providing a smarter, more sustainable way to stay aligned with evolving GMP requirements.
