ProcellaRX
Challenging the Status Quo for Digital Validation

Life sciences organizations must follow a prescribed set of regulations in software quality to maintain compliance. However, overly conservative interpretations of regulations often impede operational efficiencies. Organizations need a way to break this mold and embrace new technologies to keep pace with today’s business requirements and regulatory landscape with improved efficiency.

Leading the charge in this evolution is ProcellaRX, a strategic consulting organization dedicated to helping life sciences companies shift from outdated compliance processes and streamline their software quality operations.

“We are unafraid to push organizations in the industry beyond their comfort zones and help them move toward modern and efficient processes,” says Dori Gonzalez-Acevedo, CEO and Co-Founder, ProcellaRX.

ProcellaRX employs a ‘rethink, reshape, and remake’ framework that challenges established norms. This begins with rethinking and overturning legacy practices by fostering mindsets that embrace change by leveraging strategic assessments as the mechanism to drive modernization initiatives.

To start this journey, clients undergo a comprehensive assessment of full end-to-end processes, spanning validation maturity, associated business processes, and current use of software quality solutions. Objectives are defined at the onset of the assessment, such as CSV to CSA transformation, digital validation transformation, or shift-left software testing strategies, but a key focus throughline is emphasizing areas most critical to quality and the optimization of sustainable, reliable data-integrity practices.

ProcellaRX then diagnoses challenges while factoring in people, process, tools, and organizational culture to identify what will be required to build a framework of right-sized, optimized processes and solutions designed to achieve higher levels of SDLC maturity and operational efficiency.

Throughout the process, ProcellaRX reorients organizations toward the true primary objective of ensuring patient well-being through quality products and systems, rather than designing quality solely through the lens of business or compliance risks. This emphasizes the precision of applying transformation in the right places to meet the actual needs of different systems, like medical devices vs. quality systems, enabling clients to maximize impact and value to quality objectives.

To best support client process needs, ProcellaRX leverages leading software quality tools, such as OpenText ALM/Quality Center, a solution that has been widely adopted across the life sciences industry.

Depending on the client’s needs, ProcellaRX can then help implement new solutions into a company’s environment or deliver them as a managed services offering. The benefit of a ProcellaRX managed services offering resides in the fact that their team is staffed by industry SMEs, providing high levels of regulatory and technology management capabilities, enabling the client to focus on core quality objectives.

Regardless of tools or deployment model, the outcome of an assessment will result in optimized processes that embed quality continuously. This holistic approach integrates compliance with an agile, risk-based framework, leading to substantially improved outcomes in product and system quality.

Using this strategy, ProcellaRX helped a top global medical device company significantly increase deployment efficiency. The client had a waterfall approach and their data was dispersed in multiple applications, impeding their rapid release schedule for medical software deployment.

We are unafraid to push organizations in the industry beyond their comfort zones and help them move toward modern and efficient processes

ProcellaRX implemented a regulated agile SDLC process, consolidated the client’s framework into one application, and reduced their change control cycle to less than a month. This process took under four months to implement and enabled the client to release five products within another six-month period.

An influential figure in life sciences, ProcellaRX’s founder, Dori Gonzalez-Acevado, regularly interacts with the community to advocate the importance of effective and strategic software quality practices. Beyond software, Dori is a strong proponent and leader in the community for Diversity, Equity and Inclusion, leading ProcellaRX with this as a core organizational value.

Under her forward-thinking guidance, ProcellaRX is reimagining possibilities, reshaping perspectives, and remaking outcomes, empowering organizations to maximize efficiencies and elevate organizational culture in an increasingly dynamic landscape.