| Some of the ancient Greek philosophers adhered | | | | companies today. |
| to the unscientific view that our planet was | | | | A Document Control Software System for |
| composed of four main elements: fire, air, water | | | | Personnel Awareness and Training |
| and earth. Sometimes the more thoughtful of the | | | | Another emphasis that the regulators will never |
| "thinking Greeks" included aether into the mix but | | | | let go of is whether or not a company's personnel |
| since modern day man can hardly comprehend | | | | has been made aware of their responsibilities and |
| the term in his everyday vocabulary we'll stick | | | | has been trained to accomplish them. It's a simple |
| with the four elements that are familiar. The fire, | | | | requirement but in most realistic scenarios ends |
| air, water and earth theory may not be scientific | | | | up in nothing short of chaos. Medical device quality |
| but it's thoughtful--and best of all--it's simple. In | | | | managers need a document control software |
| fact, it was this theory/idea that probably led | | | | system that manages learning management in |
| "real" scientists to consider the physical make up | | | | addition to document control. The training/learning |
| of the things around them---thus the discovery of | | | | management module should automate planning, |
| atoms and----thus the discovery of quarks, etc. | | | | scheduling, invitation routing, online exams, grading, |
| At any rate, "starting simple" is a wise bit of | | | | escalations, tracking, etc. Without a learning |
| wisdom to remember even if everything that | | | | management component a document control |
| needs to be comprehended isn't comprehended all | | | | system is lacking the functionality to comply with |
| at once. Take for example the regulations and | | | | a very large emphasis of the Part 820 |
| standards that govern the medical device industry. | | | | requirements and the ISO 13485 standards. |
| There are certainly a lot of them and they can be | | | | A Document Control Software System for |
| intimidating. In the U.S. and in Europe (Japan as | | | | Validation |
| well) the big ones include 21 CFR Part 820 | | | | Any aspect of a medical device regulation or |
| (enforced by the FDA) and ISO 13485. Both of | | | | standard is likely to require some type of |
| these standards have their own emphases but it's | | | | validation at some point during the product |
| easy to see what the current focus of | | | | lifecycle management process. Let's talk |
| compliance in the medical device industry is by | | | | purchasing for example. If the purchasing |
| noting their similar emphases. These include: | | | | department is discussing the parts needed for the |
| - Planning | | | | future big-money-making-device then they better |
| - Personnel Awareness/Training | | | | be sure that several qualified individuals throughout |
| - Validation | | | | the organization have validated the purchase of |
| - Documentation | | | | those parts and that all BOMs (Bill of Materials) are |
| | | | up-to-date. These precautions would seem |
| Enter Document Control | | | | obvious but it's common for the purchasing |
| It's important to realize at this point that | | | | process to become a purchasing nightmare. |
| document control plays an integral part in all | | | | However, with an online document control system |
| regulations and standards that medical device | | | | that can integrate BOM collaboration, |
| companies are required to adhere to. Document | | | | documentation collaboration and the online |
| control is literally the lifeblood of compliance. In | | | | approval and escalation of purchasing tasks, a |
| other words it's the lifeblood of tracking, trending, | | | | purchasing nightmare becomes just another |
| proving and safeguarding the medical device | | | | simple responsibility that purchasing can handle in a |
| products of tomorrow. | | | | fraction of the previous purchasing time online. |
| A Document Control Software System for | | | | A Document Control Software System for |
| Planning | | | | Documentation |
| If you read between the lines of almost every | | | | When all is said and done a document control |
| current medical device regulation or standard you'll | | | | software system was primarily developed to |
| notice that the idea of planning, planning, planning is | | | | manage and control mass quantities of |
| foremost on the minds of regulators and | | | | documentation. All regulations and standards |
| standards authors. It's no surprise; they simply | | | | require significant quantities of documentation |
| want to ensure that medical device engineers and | | | | throughout the product lifecycle. The DHFs, DHRs |
| developers are thinking before jumping into the | | | | and other required medical device documentation |
| pool. Planning always costs more up front, but far, | | | | are enough to keep the heads of the regulatory |
| far less in the future. A document control | | | | department spinning. However, there are systems |
| software system is absolutely necessary during | | | | available that not only provide simple online |
| the planning phase of a medical device. Of course | | | | document control and management but also |
| it's important to be selective; the document | | | | provide BOM control, online routing for quick |
| control software system would need to be able | | | | validation, training management modules and |
| to manage, route and store CAD drawings and | | | | functionality that streamlines the planning process. |
| any other type of files common to the medical | | | | Why should medical device companies accept |
| device environment but that shouldn't be difficult | | | | anything less than the simple intelligent facts? |
| considering the vast array of products on the | | | | . |
| market for both small and large medical device | | | | |