Like all life science organizations, medical device manufacturing companies are held to strict standards set by the United States Food and Drug Administration (FDA) to ensure patient health and safety. For many medical device manufacturers, a computerized maintenance management system (CMMS) is key to ensuring compliance with all relevant standards. The right CMMS for medical device manufacturing can help ensure the integrity and safety of the manufacturing process, manage maintenance tasks and metrics, and ultimately protect patients from harm.
Benefits of CMMS for Medical Device Manufacturers
The best life sciences CMMS software solutions can provide many benefits for medical device manufacturers. A CMMS that considers the needs of medical device manufacturers will help streamline processes and increase efficiencies throughout daily operations. For example, a CMMS provides a centralized location to schedule maintenance, track unscheduled maintenance needs and maintenance expenses, manage inventory, and maintain complete and accurate records for audit and compliance requirements.
And in recent years, adoption rates for CMMS have increased significantly as many manufacturers realize these benefits. One of the first major CMMS benefits that medical device manufacturers experience is how much easier compliance can be with the help of a CMMS, particularly compliance with relevant FDA and ISO standards.
21 CFR Part 11 Compliance for Medical Device Manufacturers
For medical device manufacturers, compliance with FDA Title 21 CFR Part 11 is fundamental. 21 CFR Part 11 governs how electronic records and digital signatures must be handled for regulators to consider them just as reliable and trustworthy as paper-based records. While many manufacturers think they are in compliance, they often find they do not have the tools in place to quickly and effectively respond to an audit of their electronic records.
To learn more about 21 CFR Part 11, you can use our checklist to see how your compliance measures up.
With a CMMS for medical device manufacturing, you will quickly begin making use of the maintenance software’s many powerful features, including the ability to demonstrate compliance by running complete and accurate reports quickly at the click of a button. Beyond reporting, the right CMMS software also lets you easily assign user permissions, find documents quickly, track work orders, log equipment and inventory, and more.
To comply with Title 21 CFR Part 11, a CMMS must provide at least the following capabilities to protect the reliability, completeness, and authenticity of electronic records:
- Ability to apply digital signatures to ensure the correct resource is updating records
- Ability to access current and archived records of maintenance activities throughout the duration of a record’s retention period, including time-stamped records of modifications and revisions
- Strict security and data privacy, including the ability to restrict user access and permissions
International Compliance with ISO 13485
Beyond FDA requirements, organizations that do business outside of the United States must also comply with international regulations established by the International Organization for Standardization (ISO). For example, the ISO 13485 standard sets the groundwork for the safe and efficacious production of medical devices.
There are also two sets of requirements for laboratory testing: Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). The intent of GLP is to protect scientific data integrity. The purpose of GMP is to demonstrate that each and every batch of a product is manufactured according to established standards.
A robust CMMS software streamlines documentation for your maintenance activities, making it easier to ensure compliance with all relevant standards and approach audits with confidence.
Medical Device Manufacturer Case Study: Excelsior Medical
Let’s take a look at the benefits of CMMS software for medical device manufacturers in action. Excelsior Medical is an eMaint customer that manufactures pre-filled saline and heparin syringes. To ensure the safety of their end product, the equipment used to produce these syringes must be maintained to the strictest standards.
Excelsior signed up with eMaint CMMS software to help them manage, retain, and access records for regulatory compliance. eMaint’s CMMS can also generate on-demand reports that provide a complete and accurate record of all activities logged in the system. This capability will allow Excelsior to quickly produce records at the request of the FDA, saving them time in the event of an audit. They can now rest assured that they can quickly respond to records request without issue.
eMaint CMMS was so transformative for Excelsior Medical that they expanded the scope of the project to include their facilities maintenance as well.
Maintain Regulatory Compliance with eMaint CMMS
Whether it’s FDA 21 CFR 11, ISO 13485, or other regulations, eMaint CMMS helps highly regulated industries like medical device manufacturers improve maintenance best practices, prepare for inspections, and approach audits with confidence.
Learn how eMaint simplifies the audit process and helps organizations ensure regulatory compliance. Sign up for a free demo.
