Maintaining compliance amid tens of thousands of regulatory standards can be a major challenge for companies in the life sciences sector, which remains among the most-regulated industries. From over-the-counter medications to medical devices and equipment, people’s lives can depend on these products, which necessitates strict standards to ensure safety.
Maintenance technicians in the life sciences are no exception to these standards. It is critical for maintenance professionals to maintain thorough, accurate records for compliance with local, state, federal, and international regulations. In addition, managers must be able to track their team’s maintenance activities and give workers centralized access to processes and procedures, while ensuring accurate records in the event of an audit. This is where a computerized maintenance management system, or CMMS, comes into play.
Historically, many maintenance operations have relied on paper records and binders; however, this method is time consuming and prone to error. Now, with advances in automation, there are much easier ways to track compliance. A CMMS is a powerful tool to streamline maintenance management, comply with regulatory standards, and effectively migrate from paper records to electronic documentation.
What is 21 CFR Part 11?
One of the most important regulations that applies to electronic recordkeeping for the life sciences is 21 CFR Part 11, which establishes U.S. FDA regulations on electronic records and signatures. It governs how FDA-regulated companies must handle their electronic records and quality review processes to be considered trustworthy.
21 CFR Part 11 confirms that a life sciences company has sound business practices. It requires changes made to the program to be recorded in a clearly-documented audit trail. It demands documentation of who has the authority to make those changes via electronic signature. And it expects the ability to demonstrate that the system is operating within a validated state.
This ensures that the data is accurate, reliable, authentic, and equivalent to handwritten approvals.
The right CMMS software supports 21 CFR Part 11 requirements by creating a digital paper trail, increasing reliability and repeatability, and enabling digital signatures.
21 CFR Part 11 Compliance with CMMS Software
Maintenance and engineering teams in the life sciences sector should be aware of a handful of critical areas covered by 21 CFR Part 11. Some of those include the analysis of procedural documentation, computer system validation, and audit data.
In the life sciences, especially, maintenance management software needs robust reports and dashboards, plus quick asset history access and preventive maintenance tools that help with compliance. Having a tool with configurable reports and dashboards can make the difference between a dreaded audit and a company passing with flying colors.
That will include easy electronic documentation for modern maintenance basics like completing work-orders, scheduling equipment, cataloging spare parts, managing maintenance storerooms, and tracking technicians’ maintenance activities. In the past, only paper records could be provided to an auditor for an FDA inspection. Today, maintenance software can make it much easier to display digital documents on a ready-to-view dashboard.
So, when it comes to industry best practices, life sciences CMMS software should have the necessary requirements for compliance. Yet it still must empower maintenance teams to quickly complete their day-to-day tasks.
Beyond simply having an easier, more efficient system, maintenance teams also can reduce errors, lower overall costs, and improve safety. The below four areas highlight some of the most common improvements for maintenance teams looking to be better prepared for 21 CFR Part 11 software requirements.
4 Ways to Use CMMS for 21 CFR Part 11 Compliance
1. Automatic Work Order Tracking
Work orders are the heart of any maintenance team. A large MRO team could complete tens of thousands — or even hundreds of thousands — of work orders in a year.
That’s why comprehensive compliance evidence is crucial for maintenance teams. An auditor should be able to track work orders from creation to completion. Every stage should be documented and digitally verified by a staff member. We’d love to take Johnny Appleseed’s word, but it’s also essential to be capable of running reports for compliance that show on-time work order completion.
For maintenance teams stuck using pen and paper, this is a daunting task. However, once those records are digitized into a CMMS, organizations can reduce their audit stress thanks to easily available data. Of course, they can also eliminate hours spent logging work by hand or running back to a shop.
2. Documented Maintenance Best Practices
Within a CMMS, maintenance managers can also attach relevant regulation-specific documents to their work orders for reference. That may include anything from safety documents such as lock out, tag out (LOTO) to instruction and OEM manuals, or helpful diagrams. Organized facility and asset records can ensure work will be completed safely, efficiently, and according to the manufacturer’s recommendations (not to mention the time savings of walking back to check a binder).
As a result, the system is well-positioned to improve accuracy, as technicians follow standardized processes and procedures, like mandated work order signoffs that show a quality review. Looking beyond compliance, a complete asset work-order history also gives maintenance teams a comprehensive picture of asset health.
3. Immediate Proof of Compliance
If you’ve ever spent hours in spreadsheets manipulating data, this is for you. KPIs are vital to maintenance teams so they can turn current and historical CMMS data into the kinds of insights that enable future data-driven decisions.
Whether it’s customer audits, FDA audits, or performance reviews, maintenance leaders often rely on personalized dashboards and reports for visibility. A life sciences CMMS should offer pre-loaded reports in addition to configurable and flexible report creation that help provide proof of compliance to auditors and inspectors.
4. Real-Time Alerts and Automation
In addition to routine maintenance tasks, a technician’s day is typically filled with firefighting, work-order backlogs, and new requests. Real-time alerts help organizations stay on top of compliance tasks and ensure audit readiness.
It’s tough to remember to update every individual record at the end of the day. Enabling technicians to be mobile while responding to live alerts reduces turnaround time while maintaining compliance. The documented work-order processes and procedures maintain compliance with FDA regulations by providing a time and date stamp of the updates.
