In some industries, a defective product can only seriously harm the organization producing it. When quality starts to slip, proactive maintenance teams can spring into action to make a fix, idling keeping downtime and its costs to a minimum.
For industries like the pharmaceutical and medical defective sectors, however, a defective product can do much worse than disappoint a customer or bring production to a brief halt. These products can hurt or even kill customers if they fail to meet rigorous quality standards.
That’s why the Food and Drug Administration imposes regulations on the organizations under its management. These hold organizations accountable, promote product quality, and help guide the FDA when it needs to investigate incidents to identify their root cause.
21 CFR explained
21 CFR is the common name for Title 21 of the Code of Federal Regulations. The term refers to a broad range of requirements an FDA-regulated organization must meet to ensure its products are safe and effective.
Of 21 CFR’s many sections, two are especially relevant to maintenance teams. An appropriately proactive and strategic approach to managing assets and facilities will simplify compliance with 21 CFR Parts 11 and 820.
- Part 11 – Electronic Records and Electronic Signatures
- Part 820 – Quality System Regulation (QSR)
What is 21 CFR Part 11?
Part 11 of 21 CFR includes requirements for ensuring the safety and reliability of electronic signatures and record-keeping processes. In addition to protecting sensitive data, the regulations help organizations to minimize their use of paper by ensuring digital documents offer equivalent security.
This section also deals with software solutions used to manufacture, store, and test pharmaceuticals and regulated products. All systems must be validated appropriately. Validation is not a one-time initiative, but an ongoing process to ensure systems never deviate from their intended purpose or fail to produce accurate records.
21 CFR compliance checklist
Need help conducting an internal review? This handy checklist should make it simple to grade your operations against 21 CFR’s requirements and, if necessary, address sources of non-compliance.
Do you meet 21 CFR Part 11’s validation requirements?
- Our current system is validated and all of the approved validation documents are easily accessible.
- We can recognize invalid records or records that have been altered.
- Our records are easy to retrieve throughout their retention period.
- Our system limits access to authorized personnel.
- Our system includes user-based permissions for features like signing or altering records.
- Our system enforces process control.
- We have documented training processes for employees who use the system.
Do you meet 21 CFR Part 11’s requirements for audit trails?
- Our system includes version control.
- Our audit trail is accessible throughout the record’s retention period.
- Our signed records include the following information:
- The name of the signer
- The date and time of the signing
- The type of signing (approval, review, etc.)
- This information is displayed on all copies of the electronic record.
- Electronic signatures are unique to specific individuals.
- Our change control procedure for system documentation includes its own audit trail for all changes.
Record retention
- User passwords periodically expire.
Tips for 21 CFR Part 11 compliance
Enhance your audit preparedness with these best practices for strategic, forward-looking maintenance and document management.
- Keep your records organized and detailed: Whether you’ve got a Computerized Maintenance Management System (CMMS), a spreadsheet, or packed filing cabinets, ensure relevant records are always easily accessible and appropriately formatted. Never skimp on detail related to your maintenance and quality control activities.
- Build a strong training program: Personnel from across your maintenance department have a role to play in keeping your organization compliant with FDA regulations. Ensuring they understand all relevant policies and procedures will keep them prepared to execute their duties.
- Review and update your standard operating procedures: Your SOPs should be dynamic documents, evolving to reflect current requirements and best practices. Regular assessments and updates will ensure you’ve got the right workflows in place and can always stay prepared.
- Conduct random audits: Proactively assessing your operations could help you identify potential compliance issues well ahead of time to address them before FDA investigators come knocking.
Download our 21 CFR compliance kit
Meeting Part 11’s requirements is just one part of staying 21 CFR compliant. Our downloadable compliance kit includes more checklists and resources to ensure you meet every requirement and take the stress out of regulations. You can even download the document and customize it to your organization’s unique systems and assets. Check it out.
Simplify and digitize 21 CFR compliance
FDA-regulated companies trust Limble to help them pass audits with ease and stay in compliance with 21 CFR.
- Every Limble user has unique login credentials and users can configure platform settings to ensure passwords meet security standards.
- Limble offers access control with more than 200 unique permissions.
- Maintenance and asset performance history data are automatically stored with crucial info like assigned personnel and timestamps.
- Once users create preventive maintenance schedules they can automate task creation and store records of completed work.
- Approval requests and other workflows include an electronic signature feature.
Hear what Spectrum Solutions says about Limble
When the COVID-19 pandemic hit, Spectrum Solutions was the very first organization to obtain Emergency Use Authorization to produce saliva-based tests. With such a high-impact workload, they could not afford to fail an audit and experience shutdowns. An error-prone, antiquated system tended to make audits stressful, inspiring them to pursue a CMMS.
Limble quickly emerged as the ideal candidate to support daily maintenance needs and streamline audit preparation. The platform offers a single source of truth which has so far made it possible to satisfy FDA investigators more quickly than ever.
Check out the full case study from Spectrum and learn more about Limble’s compliance-promoting features in our guide to 21 CFR and CMMS FAQs.
