Regulatory Document Submission is one of the most time consuming, yet critical steps pharmaceutical, biotechnology and medical device companies must take to meet government requirements, ensure patient safety, and get a new product introduced to the market. While it is essential to the health of a pharmaceutical company to get its submissions issued efficiently, many companies are still unaware of the dramatic benefits they can reap from utilizing a business process management suite to handle these submissions and greatly improve the utility of its existing document management system(s).
Five reasons you should start using BPM for regulatory submissions
1. Reduce cycle times and increase efficiency
There’s no need for the last-minute rush to get documents completed and submitted on time. In fact, you would be surprised by how many companies have very little understanding of how their documents are produced, reviewed and approved before they are submitted. BPM helps companies capture, analyze, understand and optimize critical submission process data, letting you get the job done faster and more efficiently, while ensuring you are meeting all submission deadlines.
2. Complete process visibility
With BPM, you can know exactly where you are in your process at anytime. You can pinpoint the exact process you wanted automated, understand what it does and the interrelationships of the people, systems and technologies it involves, and optimize the process in a way that gives you the best advantage. Leveraging these capabilities users are able to initiate next steps, track deadlines and set up alerts to signal when specific users must take action based on clinical data becoming available. In addition, BPM processes can be easily updated and improved without requiring revalidation of other systems (e.g., Document Management, CTMS).
3. Better manage resources and roles
Social BPM capabilities allow you to define your users and what skills, training, certifications, and capabilities they have to ensure the right task is being assigned to the best person to complete it in the shortest amount of elapsed time. Work can be routed to the most appropriate employee, keeping in mind their current workload, to ensure projects don’t pile up and deadlines are met whether they are down the hall or across the globe.
4. Establish universal metrics and standards
Real-time, personalized dashboards give you the ability to monitor and track the entire document creation, compilation and submission process. From planning, document writing, scientific review, QA and approval and issuing – you know who needs to complete and approve a task at any specific time. You can also generate customizable reports on different processes, establish performance metrics and see how you’ve improved your regulatory submission processes.
5. Global accessibility
Web-based BPM suites give you the ability to access a wealth of information anywhere, eliminating geographical barriers. Work can be assigned to different users by adding a role attribute for users’ locations – ensuring people with enough hours in their work day and the right skill set can complete a task. Globalizing your customer operations not only helps you gain access to everything you need anywhere in the world, but also cuts down on operational costs. This feature gives companies the ability to truly leverage their global workforces to gain strategic advantage by effectively creating more working hours in a day.
A great BPM suite has the power to cut costs, increase productivity and transform the way your business operates. Stay tuned as we continue to discuss BPM’s influence within the pharmaceutical industry and how the combination of BPM and enterprise content management (ECM) can improve the way you get submissions done.
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