FDA regulations guide today’s practices for maintenance technicians in the life-sciences industry. Choosing and properly using the right CMMS software can make a world of difference.
By Tara Acree
For many companies, it can be tough to maintain compliance amid tens of thousands of regulatory standards. The nature of the life sciences sector has made it among the most-regulated industries. From our daily vitamins to critical hospital equipment, people’s lives can depend on the products, which leads to strict oversight. As a result, maintenance technicians in the sector must have documented records for compliance with local, state, federal, and international regulations. Managers need to track their team’s maintenance activities and give workers centralized access to processes and procedures, while ensuring accurate records for audit time. Enter: computerized maintenance management system (CMMS).
Historically, many maintenance managers have used paper records and binders to keep up with compliance. However, the push toward automation has caused life science organizations to seek a streamlined way to manage maintenance best practices while complying with regulatory standards. This has led to the migration from paper records to electronic documented standards.
When it comes to software utilized by life sciences organizations, one set of guidelines draws outsized attention. Part 11, Title 21 of the Code of Federal Regulations establishes U.S. FDA regulations on electronic records and signatures. It governs how medical device, pharmaceutical, and other FDA-regulated companies should handle their electronic records and quality review processes.
21 CFR Part 11 outlines the standards that FDA-regulated organizations must meet for their electronic records to be considered trustworthy. It confirms that a life sciences company has sound business practices by recording changes made to the program in an audit trail, documenting the authority to make those changes via electronic signature, and demonstrating that the system is operating within a validated state. These documented processes certify the data is accurate, reliable, authentic, and equal to paper and handwritten approvals.
21 CFR Part 11 regulations empower maintenance and engineering teams to advance from time-consuming paper records to the digital world. That’s why a maintenance software can either be an asset or a liability. 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 in 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, including the analysis of procedural documentation, computer system validation, and audit data.
In life science, especially, maintenance management solutions should have features like robust reports and dashboards, as well as quick access to equipment history and preventive maintenance tools that can help with compliance standards. 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, a life sciences CMMS software should have the necessary requirements for compliance while still enabling 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.
Tracking Work Orders in the CMMS
Work orders are the backbone of any maintenance operation. In any given year, an organization may complete hundreds of thousands of work orders. To make life easier at audit time, maintenance teams need to have in-depth evidence for compliance. One crucial area is to be able to follow work orders from submission to finalization, with each stage well-documented and digitally verified by personnel. While we would love to take Johnny Appleseed at his word, it’s also essential to be able to run reports for on-time work order completion as proof of compliance.
This is a daunting task for maintenance teams with paper-based maintenance work. By digitizing those records into a CMMS, companies can reduce the stress of an upcoming audit through readily available data. Of course, they can also eliminate hours spent logging work by hand or running back to a shop.
Documenting 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.
Generating Maintenance Reports
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.
Facilitating 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.
Tara Acree is an enterprise account executive for the life sciences and automotive industries at www.emaint.com, a Fluke Reliability company. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at [email protected].
