In a regulated industry like the Life Sciences Industry which covers Pharmaceutical, Biologics, Biotechnology Drugs, Medical Devices, Medical Device/Drug Combination Products, Diagnostics and Tissue Therapies, adherence to strict regulatory& quality compliance principles is a given. However, over killing what you are doing can be very costly and may be forcing cuts in other vital areas of the commercial operation. That’s why using Risk Assessment Techniques to develop a Lean Compliance strategy is a must today. This type of approach helps to define exactly what’s required to provide the appropriate level of coverage to assure compliance and meet the needs of ICH/FDA and other international regulations & guidance’s as well as maintaining a competitive edge to assure your company’s leadership position in the market place.
Through the application of Lean Compliance, you can meet your regulatory obligations and maintain your competitive edge!
A good example to illustrate this is the Risk Assessment of environmental monitoring plans to determine the appropriate level of sampling required to assure environmental control while staying within the requirements to operate an effective program.
Studies indicate that savings for modern biotechnology production facilities can be in the millions of dollars per annum due to the reduction in testing materials, testing and labor required to collect and test the samples.
Determining sample plans using a simple Risk Assessment Matrix can have a dramatic effect on this process which in turn has a material effect on the ROI for the plant.
This is an example of how Risk Assessment as part of an n overall Lean Compliance Strategy can impact the competitiveness of a modern manufacturing process. Pharmaceutical constants that are knowledgeable in Lean Management and Compliance Risk Assessment are a good resource to help initiate these types of programs so you can reduce that burden immediately without jeopardizing compliance.
