Revelle Aesthetics is on a mission to help women reveal their true selves with confidence. The Silicon Valley-based medtech company is focused on innovating smart solutions that address the root causes of women’s most bothersome aesthetic concerns. The company is committed to developing precision technologies that deliver meaningful results for women and reliable outcomes for physicians. 

Revelle Aesthetics selected TrackWise Digital to manage its key quality management processes—document management and training management.

THE OPPORTUNITY

Moving from Paper to a Digital-First Process
Revelle Aesthetics initially relied on paper-based processes, but the COVID-19 pandemic required a shift towards a more efficient approach. On top of this, the manual processing, logging and maintenance of extensive Excel logs to manage training proved to be time-consuming and ineffective.

Melissa Viotti, Revelle’s senior director of quality and regulatory affairs, explains, “We’re a small company. We’ve only been a few years into existence, and we just started commercialization. Previously we used paper processes but as you can imagine during COVID with everybody spread around, that process wasn’t scalable. It takes a lot of manual processing for the document control person to log and print. So, we had all kinds of Excel logs.”

Another area where the limitations of paper-based systems became evident was in the training processes.

“Our paper-based training system was not scalable before we had TrackWise Digital, and we were using a manual system. Before we were sending out emails, we had this massive Excel spreadsheet trying to figure out who needed to train on what.”

The reliance on email communications and using an Excel spreadsheet to track training needs posed significant challenges. Manually tracking and reminding employees about their training obligations, along with the cumbersome task of logging and managing training records, led to inefficiencies and introduced the potential for errors. Managing these processes manually also increases the risk of redundancy and data corruption. On top of this, manual audits and data entry can prove to be tedious and prone to human error.

The company recognized the need for a more streamlined solution, particularly as it was preparing to bring on a substantial number of new hires and undergo a commercial launch.

THE SOLUTION

Implementing TrackWise Digital for Holistic Enterprise Quality Management
Viotti previously used TrackWise for complaint handling, nonconformances and corrective and preventive action (CAPA) at a previous company.

Additionally, using a cloud-based solution eliminates the need for hardware investment and maintenance, so IT can focus on other critical initiatives. Drawing from Viotti’s positive experience with TrackWise, the decision was driven by the need for a comprehensive solution that could streamline their quality and document management processes.

Just before the company’s commercial launch, Revelle Aesthetics adopted TrackWise Digital. This shift eliminated the need for using paper training forms and enabled a more efficient training process. Employees could access their training requirements through the system, completing the necessary training at their convenience. This not only saved time but also presented a more organized approach to onboarding new hires.

“That was really the nice thing that we didn’t have to send new hires these old-fashioned paper forms to fill out,” said Viotti. “They could go into the system, see their list and complete their training and it looks a lot more professional for us when we’re bringing on all these new hires.”

THE RESULTS

Efficient Implementation and Enhanced Document and Training Management
Revelle Aesthetics implemented TrackWise Digital document management system (DMS), training management system (TMS) and quality management system (QMS) within a span of six months. For document management, usability was a key factor for Revelle. As a medical device company, Revelle Aesthetics is heavily regulated and must meet training compliance. They also have procedures that require certain levels of review and approval, as well as training timelines that must be met. Anyone who needs to complete their training needs to get it done and it needs to be done on time. TrackWise Digital helps automate this training process, and helps the company meet compliance.

With TrackWise Digital, Revelle Aesthetics helped alleviate the challenges associated with paper-based systems and manual processes. The transition to a digital platform enabled better training management, eliminated manual record-keeping and enabled scalability, positioning the company for success as they embarked on their commercial journey.

Adoption of TrackWise Digital Across the Organization
TrackWise Digital became an integral part of Revelle Aesthetics’ operations, with adoption spanning across various teams and job roles. Quality, engineering, R&D and marketing teams were among the primary users of the system. However, every individual in the company, regardless of their function, benefited from streamlined processes and compliance support, ensuring efficient operations and reducing the reliance on paperwork.

“The quality team is in the thick of it,” says Viotti. “We also have our engineers— so on the operations side, and on the R&D side, they’re in there doing change controls and then using the DMS for their documents. Everybody does their training in TrackWise Digital. So, it’s every person in the company who is benefiting from the system.”

Streamlined Document Approval Process and Improved Usability
Revelle Aesthetics appreciates the usability and efficiency that TrackWise Digital’s DMS provides. Loading and routing documents for approval became streamlined, as did the approval process itself. The approver receives an email and can then go into the system and approve the document immediately. The marketing team, in particular, appreciated the system’s flexibility, as it eliminated the need for full change control processes for promotional material. With hundreds of marketing pieces, the transition from a paper-based system to TrackWise Digital allowed for seamless approval processes, eliminating the need for manual paperwork and approvals.

Viotti says, “With DMS it’s really nice to just load the documents and then route them for approval. For example, my marketing colleague was telling me that she loves TrackWise Digital compared to a previous system she used. We have 300 - 400 marketing pieces already. If we were trying to manage this in a paper system, we’d still be overloaded with printing documents at this point in time.”

Reaping the Benefits of TrackWise Digital
With TrackWise Digital, the time and effort required for document management significantly decreased, allowing employees to focus on more strategic tasks. Furthermore, the system’s user-friendly interface and configurability made training processes more efficient. Instead of relying on manual reminders and paperwork, employees could access their training materials through TrackWise Digital, resulting in improved training compliance and timely completion.

Viotti states, “In terms of headcount, it was probably almost a full-time job for a quality person to process our paper documents. And now that’s quite a bit less, so that person can move on to other tasks. We also haven’t had to hire people in document control. So even as we’ve scaled, TrackWise Digital has kept us from needing to add headcount.

Compliance has been another key benefit. By automating quality processes and reducing administrative burdens, TrackWise Digital enabled the company to allocate more time and resources to core activities such as product development and marketing.

“You can’t focus on selling products if you’re constantly dealing with inefficient compliance tasks,” said Viotti. “We need to do that efficiently. If our marketing team is spending all their time doing paperwork, they can’t go out and make beautiful promotional material, for example. Or if the R&D team is spending all their time with paperwork, it’s really hard for them to work on the next gen project. The advantage here is time savings. So, we can work on the right things and do those more efficiently.”

This, in turn, enhanced their ability to bring innovative solutions to market and maintain a competitive edge.

LOOKING AHEAD

Revelle Aesthetics continues to optimize its quality, document management processes and training initiatives. Through the successful transition from paper-based processes to a digitalfirst approach, the company has demonstrated the power of digital quality. The partnership between Revelle Aesthetics and TrackWise Digital exemplifies the potential of digital solutions in optimizing processes, meeting compliance and driving success in the medical device industry.