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Quality and Process are Keys to Successful Life Sciences Product Development

[fa icon="calendar'] Sep 20, 2016 3:22:31 PM / by Pat Flanders posted in Quality & Compliance, Process

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While they aim to accomplish different things, business process management (BPM) and quality management solutions (QMS) are complementary in how they help organizations successfully achieve outcomes. For organizations that need to adhere to regulatory requirements in order to bring products to market, it is critical that they use both to guide the various activities involved in a complex environment. Ultimately, quality and process are tightly integrated and when used effectively, can provide life sciences companies with advantages in navigating their market. 

Life sciences companies must pay special attention to how they design their business and quality processes.. Iteration and development processes are strictly monitored and because of the dramatic impact these products can have on users' lives, they have to be tested and all elements documented. Unless a QMS makes smart use of automation through a process-based foundation, there's no way that it can help a company maintain the transparency and high quality delivery required during development and testing cycles.

Those who work at meeting approval deadlines and sticking to regulatory rules know that managing paperwork and tracking multiple contributors is a massive undertaking. Every aspect of the development process is reviewed multiple times and a full history of all of this must be available to pass muster in an audit from a large customer, potential investor or regulator like the FDA. Using a modern, web-based QMS like Qualio manages life sciences quality and compliance, from documentation to training so that FDA, ISO and other compliance standards are met. Quality is critical in this industry and a QMS minimizes risk while increasing the likelihood of approval.

Documentation provides a good example. To progress with development efforts, a document or other asset needs to be reviewed by multiple people and collaboration among different team members is critical. The actual distribution and approvals that are part of the documentation can, and should, be automated so that the people involved can focus on what they're good at. In this case, that means they should emphasize their subject matter expertise and let workflow and process takes care of the organizational elements of guiding a document to its final version.

When a QMS is supported with process capabilities, standard operating procedures (SOP), change management, training and collaboration can be administered and viewed to ensure it is meeting the right goals. As we have seen with the recent Theranos case of mismanagement of quality and processes, a lack of discipline and a poorly defined internal culture greatly impede the ability to create marketable products.

It's important to note we don't believe a QMS is a substitute for any particular type of activity. Rather, a QMS functions best when the processes it manages are paired with an organization mindset that seeks to be rigorous about what it delivers and the manner in which development happens. It is necessary to have clearly defined roles and responsibilities across the organization, and to be able to execute actions according to roles and team designations.

Quality is highly sought, but not so easily attained. Using a QMS and relying on defined processes can provide the foundation for delivering successful products. Qualio makes compliance a competitive advantage for our customers through helping them get to market faster, at lower cost and with less risk. Contact us today to learn more.
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