Posted by: Ethan Smith on: July 26, 2011
It’s no secret that Life Sciences is one of the most highly regulated industries with ever-increasing obligations and scrutiny. As these requirements increase it is essential that you are prepared for changes that you can expect will continue to come. Life Sciences companies should build into their operational structure a plan for continuous change and the technical agility to respond quickly to new requirements. The motivation is clear, without it, your company will not only face major financial penalties, but suffer massive blows to your image and credibility in a highly criticized marketplace.
Many companies today have handled regulatory requirements by leveraging a business process management (BPM) tool to help them understand and improve their processes. At the same time, some companies believe they’re solving their regulatory compliance problems by using an enterprise content management (ECM) tool to help them capture, manage and store highly valuable documents.
While both of these tools are helpful in managing specific components of regulatory burdens, the power of marrying the capabilities of BPM and ECM can help your organization ensure compliance on both existing and new regulatory requirements. By using BPM and ECM, you can design your process improvements to be integrated with critical content that can be accessed by users anywhere in your enterprise. You can imbed content directly into a process, ensuring all documents are up-to-date and in the correct place for users to obtain. With access directly into process and content, it is easier to monitor, track and provide audit trails to meet regulatory requirements. Systematic alerts allow you to stop relying on individuals to manually initiate next steps, such as knowing when clinical data is available for medical writing to complete a submission. By combining these two powerful technologies, you can ensure processes are completed as efficiently as possible, while also maintaining the content in the validated document management application and having a consolidated Part 11-compliant audit trail documenting every step.
The integration of process and content isn’t easy, but when viewed holistically it can put your company ahead of the curve and allow you to successfully answer any new regulatory pressures on the horizon. Our conversation around this topic doesn’t end here. Let’s continue the conversation. Join us this Thursday, July 28th at 11:00 a.m. EST for our live webinar, Compliance for Life Sciences: Improving business process and content management to deliver results.
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