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Customer Success Coach Gay Groce Shares Insights on Maximizing Your eQMS Investment

Quality Management System TipsTransitioning to enterprise quality management system (eQMS) software may seem overwhelming for medical device companies at first, especially if they are coming from a paper-based system. We asked Arena’s Customer Success Coach Gay Groce to tell us about her background and share some insights on how companies can best utilize the Arena QMS platform for their product development processes and maximize their investment.

Gay, please tell us a bit about your background.

My career began over 40 years ago at a company called Tektronix based out of Portland, Oregon. I started working part time with their manufacturing division, which built product subassemblies.

I then transitioned to a full-time position, where I focused on document control and new product introduction (NPI). I was responsible for managing the revisions for assembly drawings and bills of materials (BOMs), creating part numbers, and managing change orders in their manufacturing resource planning (MRP) system.

I worked closely with manufacturing, engineering, purchasing, quality, and other key stakeholders across the organization. This gave me a good foundation for understanding everything that goes into the design, development, and commercialization of a product.

What was your first introduction into product lifecycle management (PLM) software?

In 1996, I started working at a fitness equipment company called Precor. There I was first introduced to PLM software. I loved the fact that it allowed our team to transition from a manual, paper-based system to a more efficient electronic system.

I was at Precor until 2000 when I was approached to work at a contract manufacturing company called Flextronics. At the time, the company primarily built cell tower infrastructures and they wanted me to work with the corporate team to help configure, implement, and train employees on how to use its new PLM platform.

So how did you eventually arrive at Arena?

I worked at Flextronics for 11 years and then Oracle for three years implementing another PLM application before transitioning to a company called Kona Medical in 2014. There I was first introduced to Arena QMS.

During my time at Kona, I was responsible for setting up and enhancing the best-practice business processes around the Arena platform. I then transitioned to another medical device company called VisionGate where I was also involved in implementing Arena QMS throughout the organization. When the company lost funding in 2019, I decided to join Arena.

Arena Customer Success Coach

Gay Groce, Customer Success Coach

Describe your current role at Arena.

I’ve been working at Arena as a Customer Success Coach for almost two years. I work with customers primarily in the life sciences or medical device industry. As a coach, I support customers throughout the duration of their partnership with Arena and ensure that our eQMS software helps them reach their product development and commercialization goals.

We have a team of solution architects who are responsible for onboarding new customers and training them on how to use our system. Once customers are up and running, they are assigned to a dedicated customer success coach. This is where I come in. At this point, I consult with customers on a regular basis. If they need help tackling a certain challenge or setting up a new process within the platform, I’m there to help. As a coach, I also have access to tickets that are filed by our customer support group, and I can provide additional assistance when needed.

I also partner with our sales team and account managers to conduct annual business reviews with customers. We want to make sure that customers are maximizing their return on investment when using our software. I also work very closely with our product development team to ensure that the functionality of our system is in line with what our customers need now and into the future.

What do you think makes the role of a customer success coach unique?

I think the fact that we serve as a dedicated point of contact for customers makes us unique. My customers know that they can reach out to me and I’ll be available to answer their questions.

Because we interface with customers on a regular basis, we’re able to keep a pulse on their business needs and requirements.

Our coaches also have many years of experience working in similar fields as our customers, and we understand the challenges and complexities of the markets that our customers serve. More importantly, we have been Arena customers at some point in our career and have hands-on experience using the software. This equips us to better help our customers when they adopt the Arena platform.

What are some of the common challenges that you observe with life sciences companies regarding quality management?

In most cases, life sciences companies are accustomed to using a manual, paper-based system for managing their documentation and quality processes. As teams have become more dispersed during the recent COVID pandemic, companies realize that paper is no longer a viable option. And so, this has been a catalyst for companies to get their disconnected teams and processes into one centralized place using a cloud-based platform like Arena QMS.

Another common challenge for companies is their reliance on document management software or document-centric quality management systems. Companies discover that these systems fall short, as they focus solely on documentation control for standard operation procedures (SOPs) and other files. They fail to manage the entire product record, which includes design files, quality records, BOMs, and other critical information. By using a more product-centric system like Arena QMS, our customers can maintain a tighter connection between all of their product information and quality processes. Everything is fully integrated into one system.

Finally, companies are tasked with meeting software validation requirements set forth by the FDA. This includes validation of the actual medical device software, as well as any software that is used to design, develop, or manufacture devices. Meeting these requirements can be a very daunting and time-consuming task, as it involves the preparation of software validation plans, SOPs, and other extensive documentation including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) procedures. This documentation is needed to demonstrate that software is installed correctly, meets design requirements and specifications, and operates the way in which it was intended.

We alleviate a lot of this burden for customers by providing a validation service. Because Arena QMS is a complete software-as-a-service (SaaS) multi-tenant cloud solution, we are able to provide customers the necessary IQ and OQ documentation associated with the system. This includes a list of over 3,000 pre-defined user requirements, which are updated with every release. Essentially, customers only need to validate PQ themselves, since it addresses anything that is unique to their specific use cases of the system (e.g., user access policies or change routing approval processes). Our subscribing customers can reference the entire IQ and OQ documentation set that we provide to support an audit or FDA submittal.

What tips or best practices do you typically offer to customers to help maximize their investment with Arena QMS?
Based on my interactions with customers, I would offer these tips:

  • If you have existing forms and quality processes (e.g., CAPA records, nonconforming materials, supplier approval processes, audit processes), go ahead and enter them into the Arena platform, with the same attributes-leveraging templates. If you don’t already have your own quality processes in place, you can use our templates and tailor them to meet your individual needs.
  • Grant your suppliers and contract manufacturers access to Arena QMS so they can view product record information, review change requests, approve change orders, and have greater visibility into your quality processes. This will reduce scrap and rework costs caused by production errors and shorten your lead times for ordering parts.
  • It is not necessary to rely solely on part numbers when conducting a search for items. There are many different attributes that you can leverage around an item, change, or BOM to expedite your search in Arena QMS.
  • When initiating engineering change requests (ECRs), use the check-in/check-out function to consolidate redlines from all reviewers into one document. This will allow for more efficient and accurate tracking of revisions and provide a complete audit trail for all of your documentation.

What advancements do you envision for eQMS software over the next few years?

I think we’ll see greater adoption of eQMS software across the pharmaceutical industry.

And as our clients start to rely more heavily on Arena Requirements Management to assist with their new product development (NPD) processes, I believe they’ll be able to not only track and manage their product requirements and specifications—but streamline the risk assessment and FDA classification of their medical devices.

Life sciences companies will also need to rely more on eQMS software to help them keep track of the ever-changing regulatory requirements. To this end, Arena will strive to expand our support to meet customers’ evolving needs.

What excites you most about working at Arena?

Well, first of all, I love the people at Arena. We have an awesome team. Secondly, I love working with my customers. When I can help them solve a problem and they are happy, then that makes me feel good. I’m also excited to work with customers that are developing cutting-edge technology for cancer treatment, robot-assisted surgery, remote patient monitoring, and more. My customers are truly amazing!

Do you have gaps when it comes to synchronizing your product and quality records? Read our free ebook to learn how a product-centric eQMS can help and check out our ultimate guide to QMS software.