Alleviating Headaches From 21 CFR 820 Design Control Compliance

Speaking from experience, it is excruciating for the technical lead to be unable to find the exact document and information required by the regulator. Even worse, is to find a document that has not been properly signed and dated. - Matt Lowe, Chief Product and Marketing Officer, MasterControl

Aligning Design Control With 21 CFR 820

The U.S. Food and Drug Administration (FDA) requirements for design control processes are outlined in 21 CFR Part 820. Good design focuses on safe, compliant, and competitive outcomes. It implies congruence with standards, regulations, and markets. Yet, medical device design is a creative and collaborative process that doesn’t always follow linear patterns. It resembles more closely a spinning wheel, passing through many reiterative cycles. Are you seeing stars yet?

The FDA’s Perspective on Medical Device Design Controls

The FDA’s Division of Industry and Consumer Education (DICE) defines design control as a subsystem of quality control practices within the larger system of design and development. ¹ A general overview follows:

• Define device requirements and specifications.
• Review and get signoff from all involved parties.
• Verify that design specifications match design requirements.
• Validate specifications align with the original user needs and intended uses.
• Transfer design specifications in preparation for production.
• Change any component of the design at any point in the device life cycle.

The primary purpose of any design control system is to identify, document, validate, verify, review, and approve the design and any changes before they are implemented, all the while ensuring readiness for an FDA inspection. This easily adds up to thousands of documents that must be recorded, organized, and reviewed. Medical device manufacturing software can simplify this process.

Efficient Design Controls Are Integral to Quality Medical Device Manufacturing

According to the FDA, many recalls stem back to a lack of efficient design controls and are preventable. Consequently, design controls were added to the current Good Manufacturing Practice (cGMP) requirements under the Safe Medical Device Act of 1990.

The design control section of the Guide to Inspections of Quality Systems (QSIT) identifies 15 steps for compliance with the 21 CFR 820 design control components outlined above. ² This guide can help you be prepared, but for any audit to be successful, your inspector must be able to verify your compliance. That’s where the DHF comes into play.

Your Rx: A Complete and Connected DHF 

The design history file (DHF) is a repository of all documents related to your medical device design. It’s a collection of all specifications, decisions, and actions. The design history file shows you the whole picture through medical device design definitions to design specification transfer. It also records any design changes from any phase of the product life cycle. The DHF in turn serves as the basis for FDA inspections. An automated design control system, including an electronic DHF, facilitates compliance and lets you be prepared for inspections on the spot.

The FDA targets specific details of the medical device design history file as the following language frequently used in their warning letters shows:

“The Design History Files for XXX did not include documentation that the device had ever been validated before production and marketing. When requested, the firm was unable to provide documentation that validation and risk analysis had been performed.” ³

A digitized DHF allows you to manage what can seem unmanageable. This is ideal for startups, years into research and development, as well as established, frequently audited enterprise companies.

Top Six DHF Pain Points: Critical Insight from an Industry Veteran

Medical device industry veteran and MasterControl Chief Product and Marketing Officer Matt Lowe outlines six notable challenges of paper or hybrid DHF processes that he has regularly met in the trenches of medical device design and development. As a holder of several patents for various medical devices, he speaks from experience about the difficulties the following issues can cause:

1. Being unprepared for an audit opens the door for compliance failures.
2. The design review process is sprawling.
3. Getting signatures from top executives can be challenging.
4. Change control and corrective action/preventive action (CAPA) are difficult from a postmarket position.
5. Human gatekeepers are inefficient.
6. Preparing both a U.S. DHF and a foreign market dossier requires staff duplication.

He identifies design review as one of the most challenging parts of design control that directly impacts the DHF. The scattered and painful nature of “sign-off parties” can remind you of a migraine that goes on for days.

Key features of the Quality Excellence software solution target the review components of the DHF as part of a comprehensive system. MasterControl’s DHF management tools let you immediately visualize where you are in your design process, determine whose input you need, and provide all pertinent documentation with a time-stamped audit trail. You can trust in automated document routing for signatures, follow-up, and escalation and collaborate through secure and signal communication. Signatures are electronic, compliant with 21 CFR Part 11, and remotely available 24/7. Executives can sign off anytime and anywhere because it’s based in the cloud. You can rest easy while managing the symptoms of FDA inspection or audits.

The Best Medicine of All: Streamlined Compliance

Congratulations! It’s a design history file that meets 21 CFR 820 and passes FDA inspection! Evaluate your current design control process and compare it with new, trending, and improved processes and tools. You may find you need to pace your adoption of automated design control. The modular nature of MasterControl enterprise quality management system (EQMS) software gives you options to treat your symptoms one at a time or all at once. MasterControl offers much more than a placebo. Our medical device manufacturing software encapsulates best-practice workflows that help you manage design processes more efficiently. Take a dose of our DHF solution and call me in the morning. I can’t wait to see how much better you feel.

References:

1. “Design Controls,” FDA Small Business REdI presentation by Stanley Liu, June 16, 2014.
2. “Guide to Inspections of Quality Systems – Quality System Inspection Technique,” FDA, Aug. 1999.
3. Supra note 1.
4. “How to Address the Top 6 Pains in DHF Management,” by Matt Lowe, MasterControl.