Thinking about Medical Device Regulations in Four Parts: Making Compliance Simplistic with a Document Control Software System

Some of the ancient Greek philosophers adhered to the unscientific view that our planet was composed of four main elements: fire, air, water and earth. Sometimes the more thoughtful of the "thinking Greeks" included aether into the mix but since modern day man can hardly comprehend the term in his everyday vocabulary we'll stick with the four elements that are familiar. The fire, air, water and earth theory may not be scientific but it's thoughtful--and best of all--it's simple. In fact, it was this theory/idea that probably led "real" scientists to consider the physical make up of the things around them---thus the discovery of atoms and----thus the discovery of quarks, etc. At any rate, "starting simple" is a wise bit of wisdom to remember even if everything that needs to be comprehended isn't comprehended all at once. Take for example the regulations and standards that govern the medical device industry. There are certainly a lot of them and they can be intimidating. In the U.S. and in Europe (Japan as well) the big ones include 21 CFR Part 820 (enforced by the FDA) and ISO 13485. Both of these standards have their own emphases but it's easy to see what the current focus of compliance in the medical device industry is by noting their similar emphases. These include:

• Planning
• Personnel Awareness/Training
• Validation
• Documentation

Enter Document Control
It's important to realize at this point that document control plays an integral part in all regulations and standards that medical device companies are required to adhere to. Document control is literally the lifeblood of compliance. In other words it's the lifeblood of tracking, trending, proving and safeguarding the medical device products of tomorrow.

A Document Control Software System for Planning
If you read between the lines of almost every current medical device regulation or standard you'll notice that the idea of planning, planning, planning is foremost on the minds of regulators and standards authors. It's no surprise; they simply want to ensure that medical device engineers and developers are thinking before jumping into the pool. Planning always costs more up front, but far, far less in the future. A document control software system is absolutely necessary during the planning phase of a medical device. Of course it's important to be selective; the document control software system would need to be able to manage, route and store CAD drawings and any other type of files common to the medical device environment but that shouldn't be difficult considering the vast array of products on the market for both small and large medical device companies today.

A Document Control Software System for Personnel Awareness and Training
Another emphasis that the regulators will never let go of is whether or not a company's personnel has been made aware of their responsibilities and has been trained to accomplish them. It's a simple requirement but in most realistic scenarios ends up in nothing short of chaos. Medical device quality managers need a document control software system that manages learning management in addition to document control. The training/learning management module should automate planning, scheduling, invitation routing, online exams, grading, escalations, tracking, etc. Without a learning management component a document control system is lacking the functionality to comply with a very large emphasis of the Part 820 requirements and the ISO 13485 standards.

A Document Control Software System for Validation
Any aspect of a medical device regulation or standard is likely to require some type of validation at some point during the product lifecycle management process. Let's talk purchasing for example. If the purchasing department is discussing the parts needed for the future big-money-making-device then they better be sure that several qualified individuals throughout the organization have validated the purchase of those parts and that all BOMs (Bill of Materials) are up-to-date. These precautions would seem obvious but it's common for the purchasing process to become a purchasing nightmare. However, with an online document control system that can integrate BOM collaboration, documentation collaboration and the online approval and escalation of purchasing tasks, a purchasing nightmare becomes just another simple responsibility that purchasing can handle in a fraction of the previous purchasing time online.

A Document Control Software System for Documentation
When all is said and done a document control software system was primarily developed to manage and control mass quantities of documentation. All regulations and standards require significant quantities of documentation throughout the product lifecycle. The DHFs, DHRs and other required medical device documentation are enough to keep the heads of the regulatory department spinning. However, there are systems available that not only provide simple online document control and management but also provide BOM control, online routing for quick validation, training management modules and functionality that streamlines the planning process. Why should medical device companies accept anything less than the simple intelligent facts?

.