Life science organizations have a lot of regulations to comply with… Luckily, eMaint is here to help.
Life science industries—such as pharmaceuticals, food and beverage processing, botanicals, or biochemical —are required to have more robust reporting and auditing than other industries. Lives can depend on the quality of product created in these facilities.
What is 21 CFR 11?
The U.S. Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Office on National Drug Control Policy (ONDCP) all use Title 21 CFR to govern food, drug, cosmetic, or other public health products. While the entirety of Title 21 CFR covers health products, part 11 specifically covers the implementation of electronic signatures on required paperwork and the standards of use.
Title 21 CFR has been around for a long time. Even part 11, creating the digital paper trail, has been around since March of 1997. Establishing a digital paper trail for all work completed within facilities allows inspectors and auditors to view important information without digging through physical documents. Title 21 CFR part 11 covers hardware and software, electronic signatures for these records, and the implementation of these programs.
Previously, paper records would need to be submitted to the FDA for compliance audits. However, Title 21 CFR Part 11 provides a guide to submitting electronic records to prove compliance with federal regulations. Paper records are still allowed, but it’s much easier for organizations to send digital records for compliance audits if an electronic system is available.
Improve 21 CFR 11 compliance with a CMMS
A computerized maintenance management software (CMMS) system can help organizations maintain compliance with federal codes, whether that’s Title 21 CFR 11 or other regulations. A CMMS digitally tracks maintenance efforts and provides workers with access to standard procedures and processes, along with tracking spare parts, asset measurements, and more.
Organizations are also required to comply with production documentation accuracy, reliability, and consistency regulations. Records must be secured and protected against tampering. When documents have been altered, their electronic signatures are no longer valid and regulatory compliance could be at risk.
Luckily, eMaint is here to help. Reporting, archiving, and electronically signing documents in eMaint will help organizations remain in compliance. Some of the ways eMaint can help prove compliance include:
Tracking work orders Follow work orders from submission to finalization, with each stage well documented and digitally verified by personnel. Come audit time, organizations will have detailed evidence of compliance.
Documenting worker procedures Users can attach an array of documents to eMaint work orders, including safety procedures, asset measurements, equipment diagrams, manuals, parts orders, and more. Auditors can easily access worker processes, parts histories, and storeroom values to prove compliance.
“eMaint helps us take a look at what’s going on with equipment to help identify problems, determine more cost-effective maintenance practices, and drive good financial decisions,” said Mark E., Director of Facilities and Real Estate at Caris Life Sciences.
Verifying equipment calibration After equipment has been repaired, it should be thoroughly tested prior to returning to service. Pre-operational equipment calibration and testing can be documented in eMaint. Show auditors that all equipment is running optimally and calibrated to standards.
Generating reports eMaint allows maintenance teams to create personalized dashboards and reports. Include charts or graphs, then export reports to text or PDF. This provides compliance proof to auditors and inspectors, as well as improving KPI reporting internally.
Automating update alerts Updating older documentation can be difficult to remember without reminders. eMaint can send automatic alerts to users when compliance documentation needs to be updated or assets need safety-related inspections. This helps maintenance teams stay on top of compliance tasks before an audit.
Whether or not a facility has a digital document control system currently in place, eMaint can help organizations plan, implement, and continually improve their processes to meet regulatory compliance. Be prepared for the next audit with eMaint CMMS.