Medical device manufacturers are required to follow Good Manufacturing Practice (GMP) procedures to ensure that their products are safe, reliable, and effective. The US Food and Drug Administration (FDA) details specific GMP regulations in Title 21 of the Code of Federal Regulations, commonly known as 21 CFR. Many of those regulations, especially in 21 CFR Part 820, directly concern asset and facility maintenance in medical device manufacturing.

21 CFR Part 820 defines quality standards for medical device manufacturers, mandating preventive maintenance and calibration tasks, facility management, and personnel training. We’ll talk about how to stay compliant with Part 820, and how to use a validated computerized maintenance management system (CMMS) to automate and document compliance workflows.

What Is 21 CFR Part 820?

21 CFR Part 820 regulates quality systems for medical device manufacturers who manufacture or sell their products in the United States. It mandates thorough design and quality controls throughout the production process, with the purpose of ensuring that manufacturers deliver consistently safe, high-quality products.

Not everything in 21 CFR Part 820 relates directly to maintenance operations; the regulations also cover design, packaging, and other activities, covering the entire lifecycle of the medical device. This article focuses on the maintenance, calibration, and servicing required by Part 820.

What Does 21 CFR Part 820 Mean for Maintenance Operations?

The regulation requires organizations to demonstrate that they have clear and effective systems for asset and facility management, as well as staff training and documentation processes. Here’s what that looks like.

Calibration and Preventive Maintenance

Part 820 requires organizations to regularly calibrate, inspect, and maintain their production equipment. The regulation calls for routines, schedules, and preventive actions designed to keep critical assets in optimal condition. Assets must also be correctly handled and stored so that they remain fit for purpose.

All calibration, maintenance, handling, and storage processes must be correctly documented, and the calibration standards used should be aligned with national or international standards.

Facility Management

Organizations must regularly clean and sanitize their production facilities to prevent contamination or quality issues. Equipment and tools must also be regularly cleaned and inspected.

When environmental changes like temperature, humidity, and pressure are likely to have an effect on product quality, manufacturers are required to put procedures in place to control these variations throughout the facility.

Organizations must thoroughly document cleaning, inspection, and environmental controls.

Training

All production and maintenance teams must be trained in relevant operating procedures and methodologies for their field. Personnel must be taught to spot defects that may arise during production so that they can flag errors. Training and certification should be thoroughly documented.

Corrective and Preventive Action (CAPA)

Medical device manufacturers must have a system in place to handle repairs as needed. This means pinpointing and diagnosing asset failure, taking corrective action, and implementing steps to prevent further asset faults. These steps must also be documented.

Documentation and Record Keeping

All maintenance, repair, and calibration activities must be documented, and organizations must keep records on file. Documentation must be easily accessible for inspection.

Adjacent regulations like 21 CFR Part 11, which covers the use of electronic records, requires that access be carefully managed so that unauthorized personnel can’t make changes to data. Audit trails must also be attached to all documentation.

Complying with 21 CFR Part 820

All medical device manufacturers that manufacture and distribute their products in the United States must comply with 21 CFR Part 820.

Compliance with 21 CFR Part 820 is an ongoing process; it requires meticulous attention to detail, and also an eye on the bigger picture of patient safety and product reliability.

Maintenance managers need to implement and track preventive maintenance and calibration plans. It’s important to put standard operating procedures in place and ensure that teams are fully trained to follow SOPs.

It’s also crucial to track asset performance and key health indicators like vibration levels and temperature, so that you can stay ahead of any serious equipment faults. For facility management, managers must put in place cleaning and inspection schedules. You’ll also need to monitor temperature, humidity, and pressure throughout your worksites.

Documentation is important as well; organizations need to keep careful, accurate records of all maintenance and calibration workflows, as well as inspections.

Staying compliant can be overwhelming, especially for managers tasked with overseeing multiple worksites or operating with limited resources. Fortunately, the right software can help.

Achieving Part 820 Compliance with eMaint CMMS

A good CMMS, like eMaint, can help with every aspect of Part 820 compliance as it relates to maintenance operations. Here’s how.

Preventive Maintenance and Calibration

CMMS software acts as a central repository for all your asset data, from work orders to maintenance history. Robust reporting features help you create an accurate asset hierarchy and design a customized preventive maintenance and calibration plan for your critical assets.

A CMMS automates the scheduling process so that you maximize your resources and make the best use of your planned downtime. Inventory tracking ensures that you always have the right parts on hand.

Standardizing Workflows

Work orders include checklists and built-in safety reminders, so your teams always know exactly what needs to be done. If you operate multiple sites, this feature is especially helpful for maintaining a consistent reporting process among staff.

Training

CMMS software tracks your employees’ training and certifications. That way, smart scheduling processes can ensure that the right employees are assigned to tasks they know how to complete.

Documenting Compliance

A CMMS automatically tracks and records maintenance tasks. Inspections, calibrations, and PMs are all stored in one central location, with time-stamped audit trails automatically built in. Role-based access features keep your information secure, while audit dashboards enable fast data retrieval so you’re always prepared for inspections.

Validating Your CMMS

CMMS software must be validated (and regularly re-validated) for use in 21 CFR-compliant workflows. eMaint experts can guide you through the computer system validation process and help you plan the most efficient way to use eMaint CMMS — so you can deliver consistently effective, safe, and high-quality products to all your customers.

To learn more about what eMaint can do for your organization, click here.