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 Pharma & Healthcare

Changes in the economic environment as well as lobbying from customers have led the Food and Drug Administration to promote the adoption of a risk-based approach to Regulatory compliance.

In early 2002 the FDA announced it's "Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk-Based Approach". Active Risk Manager supports the development of Risk Management Plans (RMP) through identifying possible risks associated with both the product and process used to develop, manufacture and distribute healthcare products.

In an industry where getting a new and original product to market is comparable to locating a needle in a haystack, working out how to reproduce it, testing it on all the straw in the haystack to ensure there are no unwanted side effects, and then selling it to every piece of hay before everyone else copies it and sells it to the hay for less, completing projects on time is of paramount importance. Planned and scheduled arrival of a product in the market place is critical to the profitability of that product.

A formal risk identification and mitigation process is now accepted as a basis for prioritizing compliance actions and remediation. Active Risk Manager will assist FDA regulated organisations to demonstrate compliance in the identification, assessment, communication and control of the specific risks faced by the organization and the steps taken to ensure that each one is adequately managed.

Healthcare manufacturers need to employ best practice in risk management principles to respond to the challenges of new discoveries and ways of doing business. Active Risk Manager can play an important part in helping companies stay ahead in terms of competitiveness and compliance in an ever more regulated and fiercely competitive sector.