Building a Foundation Now
With ideas and products that may create a difference, begin-up medical device companies have a story to inform and are aren't afraid to inform it. Despite their brilliance, but, many start-up medical device corporations frequently fail to form the essential foundation that is usually required for the creation of an organization that one) attracts potential mergers, or that 2) smoothly transitions into enterprise-level growth. This foundation, though easy in nature, typically becomes a haul--a "boring" endeavor--clearly not enjoyed by engineering and/or most management executives.
Net Document Management as a Foundation for a Quality Management System Roll-Out
For begin-up medical device companies that always exist without a high quality management team or maybe for those that DO have a high quality management representative, quality assurance is NOT a top priority. Qc are often implemented so as that a final product be deemed successful but quality assurance and its associated proofs, documentation, and pre-style documentation requirements are simply not possible for an organization within the race to plug a first-time product.
A Question
What if, however, medical device begin-up companies may effectively (and very quickly) founded the inspiration for an entire FDA-compliant quality management system without spending a fortune or hiring a team of quality management professionals?
The answer is that with new technology enablers, start-up companies will do exactly that.
Enablers: Internet Document Management, etc.
With the right web document management resolution, begin-up medical device corporations will simply afford hosted web document management solutions that streamline, control, manage and effectively archive all documentation that will, upon subsequent growth of the company, be able to evolve into a good quality management system (i.e., Design Management, Audits, Change Control, CAPA management, bill of materials management, provider management, etc).
Searching for a Net Document Management System
Begin-up firms should look for a net document management answer that not solely provides document control and management but which will conjointly be doubtless rolled out into a complete quality management and/or product lifecycle management solution.
When looking out for this kind of internet document management resolution, medical device "shoppers" ought to contemplate the subsequent potential features:
? A web document management resolution that can manage and control all essential documentation agnostically (i.e., will accept all document sorts);
? Can remain in an exceedingly price range that makes ROI potential within a brief time period (i.e., not many years);
? Will be internet-primarily based and hosted;
? Will be easily rolled out into a full-scale quality management system;
PLUS...
? A net document management answer that can allow users to utilize their own style input templates;
? Can offer a purposeful user-interface via MS Word, Outlook or SharePoint;
? Will automatically route appropriate documents to a centralized DHF file location;
? Can be configured to route documents through a collaboration part (i.e., a virtual meeting space);
PLUS...
? A net document management solution that can notify users (via email) when a document has been redlined;
? Will enable users to include attachments with routed documents;
? Can permit users to effectively manage the roles and rights of users;
? Can offer preconfigured reports and customizable report options;
PLUS...
? A net document management resolution that will permit users (once they need their products out there) to regulate documents such as SOPs, basic CAPAs, coaching records, etc.;
? Will permit users to work out their own approval process;
? Will require signatures (21 CFR Half eleven);
? Will manage 3D drawings in a very centralized archive (managed and routed as 2D renditions);
? Can provide the ROI data necessary to convince senior management that the solution is worth the effort.
Conclusion
Most start-up medical device companies refuse to take a position in ERP systems or pricy document management systems and are smart for doing so. Begin-up medical device firms ought to contemplate the net document management and quality management solutions that grow as their company does.
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