It is said that Medical Device Producer today have to chose between keeping a large quality bureaucracy in place to cope with abundant and complex regulations or to leave the industry all together.
“Every R&D manager I have talked to agrees that an un-proportional amount of valuable R&D resources is locked up in the documentation and administration of Design History Files. They also agree that their innovation capability is severely restrained by this situation. “- claims Karl Larsson, Marketing Director at Aligned AG.
Some of these burdens can be lifted by applying the adequate processes and support tools. “What keeps surprising me is that so many Medical Device Producers use applications like Word and Excel to manage their Design History Files, applications which are clearly inadequate for handling the challenges involved.” – Mr. Larsson continues. “It is like requiring a Mechanical Engineer to use MS Paint to produce high-quality mechanical drawings. The drawbacks are obvious.”
"The current situation in many firms uncovers a strong desire for a structured, automated and software supported DHF Management, targeted to significantly cut the resources spent on the administration of DHFs. Aligned Elements is our solution to that problem."
Aligned Elements is a dedicated system for managing Design History Files to ensure exceptional transparency, consistency and control using a minimal effort. Aligned Elements integrates the processing of Requirements, Specifications, Risks, Tests, Design Reviews and Defect Tracking with Traceability Management, automated Consistency Checks, bi-directional integration with Microsoft Word, Digital Signatures and much more.
“We have made Aligned Elements V1.6 even more attractive for the Medical Device industry by making Industry Regulations an integral part of the system. You can now check how well your DHF content matches the rules of given norms and regulations. Furthermore, we have managed to seamlessly integrate Defect Tracking Items from external systems such as Altassian’s “Jira” and the Open Source System “Trac”. These Items can now be managed and traced from within the Aligned Elements Client.
Aligned Elements V1.6 is available as of 12th March 2009.
Aligned (aligned.ch) has set out to become the leading player for ensuring and documenting the compliance of products in highly regulated markets. We assist our clients in developing, manufacture and market regulatory compliant products with higher confidence, to lower costs and within shorter timeframes.
Our clients are users, manufacturers and suppliers in the medical device industry, companies who develop, manufacture, market and use products which are subject to regulatory guidelines such as the FDA Quality Systems Regulations, the EU In Vitro Diagnostic Directive and the EU Medical Device Directive. Aligned was founded in 2006 with headquarters in Zurich, Switzerland.