Tuesday July 16, 2013
The concept of analytics has been a buzz worthy topic for the past decade, and for good reason. Analytics harvests data and information that is being produced by routine business transactions and transforms it into usable information.
Analytics have been used to fuel big-picture direction in a company. Analytics in the realm of a regulatory environment is referred to as Compliance Analytics. Compliance Analytics can be leveraged to meet FDA reporting requirements. Consequently, risk is also reduced. Typical areas that life sciences companies utilize Compliance Analytics are as follows:
• DEA Suspicious Orders – Automatic identification prior to fulfillment
• Return Credit Verification – Monitor and Verify return transactions
• Post-Market Surveillance – Reduce reputational harm and potential cost of rework and recalls
• Product Discovery – Identify product feasibility prior to launch
• Risk Evaluation and Mitigation Strategies (REMS) – enhance evaluation methodologies and reduce risk
• Aggregate Spend – Automatic compilation for disclosure compliance
• Supplier Performance – Dashboards to optimize spend, efficiency, and compliance
• CAPA and Root Cause Investigation – Simplify CAPA identification of discrepancies
• Product and Portfolio Management – Visualize aggregate data for investment decisions
Compliance analytics can explore unused data and make it useful to the business. The emerging trend is to use compliance analytics to leverage unused data ultimately to increase compliance measures, decrease regulatory susceptibility, expand quality reach, boost product quality and assure patient safety.
Posted by: Derek Jager, Validation Analyst