Title 21 CFR Part 11 Compliance for Medical Device Manufacturing

When developing and manufacturing electronic devices intended for medical use, strict record-keeping is essential to ensure compliance with United States Food and Drug Administration (FDA) regulations. These regulations, known as "Title 21 CFR Part 11", are part of the Code of Federal Regulations and specify the criteria under which electronic records are considered legally equivalent to paper records.

Strict Requirements for Electronic Records

To meet the stringent requirements of Title 21 CFR Part 11, an electronic record-keeping system must provide:

1. A secure, computer-generated, time-stamped audit trail that tracks all actions and changes.
2. Protection against unauthorized alteration or deletion of records.
3. Unique user identification and electronic signatures for each individual accessing the system.
4. Validation of the system to ensure accuracy, reliability, and consistent performance.

These requirements ensure the integrity, authenticity, and confidentiality of electronic records throughout the product lifecycle.

Lot Tracking and Traceability

In addition to the electronic record requirements, Title 21 CFR Part 11 mandates lot tracking (also known as lot control) for medical device manufacturing. Lot tracking provides bi-directional traceability:

1. Forward Traceability: The ability to identify all production batches and devices that used a specific manufacturer or distributor lot number. This is crucial for locating and recalling potentially faulty devices.
2. Backward Traceability: The ability to trace a device's serial number back to the specific manufacturer or distributor lot numbers of the components used in its production. This allows for parts to be tracked to their source in case of issues.

Implementing a comprehensive lot tracking system is essential for maintaining compliance and ensuring patient safety.

Challenges for Hardware Startups

Meeting the requirements of Title 21 CFR Part 11 can be challenging for hardware startups designing and manufacturing medical devices. Few electronics inventory tracking systems claim to be compliant with these regulations, and even fewer actually meet all the necessary criteria.

Developing a compliant system in-house requires significant resources and expertise in both software development and regulatory compliance. Non-compliance can result in costly penalties, product recalls, and damage to the company's reputation.

PartsBox: Your Partner in Title 21 CFR Part 11 Compliance

PartsBox understands the unique challenges faced by medical device manufacturers in achieving Title 21 CFR Part 11 compliance. Our inventory management system is designed to meet the strict requirements for electronic records and lot tracking, providing you with a reliable and compliant solution.

With PartsBox, you can:

• Maintain secure, time-stamped audit trails for all actions and changes
• Protect records against unauthorized alteration or deletion
• Implement unique user identification and electronic signatures
• Validate the system for accuracy, reliability, and consistent performance
• Establish comprehensive lot tracking for forward and backward traceability
• Streamline your inventory management processes while ensuring compliance

If you need a Title 21 CFR Part 11 compliant solution for your medical device manufacturing, contact PartsBox today.