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Pharmaceutical R&D compliance - Addressing compliance issues through commitment tracking

Efficiency can be a lost art in Pharma, a reality that reveals itself every day through the R&D compliance process. Pharma leaders will recognize that significant time, energy and budget is spent chasing their proverbial regulatory tails.

Get the full article on addressing compliance issues through commitment tracking.

Even with Herculean administrative efforts, crucial mandates are missed that result in delays – and in some cases, in clinical trials or critical marketing materials being sent back to the drawing board.

Considering the fallout from a late-stage trial or product promotion that is set back due to documentation errors, identifying and correcting trouble spots can have a positive impact on pipeline and ultimately on shareholder value.

Commitment tracking is a key step towards a healthy compliance process, as traditional metrics gauged by quality management systems (QMS) can become too complex to offer a reliable, rapidly delivered snapshot that can lead to action.

Current QMS measures incorporate as many as 70 interrelated metrics, often only captured by audit, post hoc with values that can be erratic and with a wide window for error.

These elements make the measurements difficult to understand at a glance.

 

To find out more about addressing compliance issues through commitment tracking, please contact us now.