mdi Consultants, Inc. and FDAAware Enter into Partnership to Implement FDAAware in the Life Science Industry
mdi and FDAAWARE have entered into a partnership to make the Life Science Industries familiar with the newly developed cloud-based database to assist with reducing the risk of regulatory issues during upcoming FDA inspections.
NY mdi CONSULTANTS, INC (mdi) and NJ FDAAWARE April 5, 2016 – mdi, the leader in FDA regulatory consulting since 1978, and FDAAWARE have entered into a Partnership to make the Life Science Industries, regulated by the FDA, familiar with the newly developed cloud-based database...
NY mdi CONSULTANTS, INC (mdi) and NJ FDAAWARE April 5, 2016 – mdi, the leader in FDA regulatory consulting since 1978, and FDAAWARE have entered into a Partnership to make the Life Science Industries, regulated by the FDA, familiar with the newly developed cloud-based database to assist with reducing the risk of regulatory issues during upcoming FDA inspections.
FDAAWARE is the ONLY cloud-based risk management platform fully integrated with FDA FOIA gathering compliance intelligence to assist companies in understanding and evaluating the most up to date FDA regulatory stance allowing companies to potentially reduce the likelihood/severity of 483s. FDAAWARE uses a unique algorithm, combined with client-specific inputs, to identify potential risk areas, assist in significantly reducing clients’ compliance risk, and better prepare them for future inspections.
In over 38 years in business, mdi has been very careful in partnering and promoting “new” items to their clients and industry. After mdi had a chance to review and use the FDAAWARE database, we determined this platform could be a very valuable tool to the Life Science Industries in developing a better understanding of what is being keyed in on by the FDA investigators. The FDAAWARE database not only supplies the inspectional 483s and warning letters, the database also sorts the observations via their corresponding regulatory statue to demonstrate the areas of major FDA concern. As a database user, you would also be able to sort the information by a particular FDA investigator (which is a very useful function when preparing for a scheduled FDA inspection). This FDAAWARE database can save a company a lot of time and effort in trying to prioritize the risks associated with an upcoming inspection, down to the investigator’s pet peeves. The information collected in the database could also serve as a great training tool for strengthening your Quality System.
mdi will be able to provide companies who use the FDAAWARE database with assistance on interpreting the significance and associated risk of the regulatory issues found with past inspectional 483s / Recall / Warning Letters / EIR database.
The developer of FDAAWARE, cResults company has entered into partnership with mdi to market, promote and implement FDAAWARE in the life science industry. mdi is a leader in providing consulting services to the healthcare industry worldwide. mdi Consultants provide unparalleled expertise in assisting medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations.
Mr. Alan Schwartz, mdi Executive Vice President, who has been working in the life science industry for over 40 years, said “After seeing what FDAAWARE is capable of providing to our clients in a couple of clicks, it was very impressive; utilizing FDAAWARE information while auditing our clients enables us to augment our experience with factual data based on the FDA historical activities. This will provide our customers with access to the most accurate and up-to-date compliance related data, which they can leverage to improve their quality in general and FDA inspections readiness in particular.”
Mr. Rafi Maslaton, Co-Founder and President of cResults, stated “This is a win-win situation. Leveraging the synergies between mdi’s presence in the industry & vast experience in the compliance space and FDAAWARE’s unique capabilities, provides an exceptional opportunity to immediately add value to mdi & cResults’ clients and support new upcoming installations.”
Mr. Eyal Maor, Co-Founder and COO of FDAAWARE, added that “the robustness of the FDAAWARE platform is common to other SQX solutions that are used by 1000s of users worldwide.”
About cResults: cResults, an IPS affiliate, develops software solutions for the Life Sciences and High Tech industries. Founded in 2005, owned and managed by industry-trained and experienced professionals, cResults' mission is to improve the overall operational performance of its clients by reducing compliance risk and overall costs, increasing productivity and improving overall organization efficiency. cResults’ software solutions are now implemented in some of the largest Pharmaceutical, Medical Devices and Biotech companies worldwide and have proven to provide value and benefit customers for the past decade. cResults headquarters are located in NJ.
About mdi: mdi is a leader in providing consulting services to the healthcare industry worldwide. mdi Consultants provide unparalleled expertise in assisting medical device, pharmaceutical, nutritional supplements, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations. mdi Consultants utilizes its unique and innovative three-part approach to provide high quality services to its clients. This includes: (1) Unsurpassed consulting experience – identifies and recruits only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to its clients, (2) Up-to-date systems and processes – utilizes highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment. Finally, (3) involvement in regulation development – stays ahead of policies by participating in the development of regulations (e.g. HACCP, Scientific Advisor to U.S. Congressmen)
For more information contact MDI Consultants, Inc.