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Inside Arena: Ensure FDA Software Validation With Arena Validate

FDA-Software-ComplianceFor this edition of “Inside Arena,” we take an insider’s look at Arena Validate. Recently renamed (formerly Arena VMS) and offering expanded coverage, Arena Validate enables customers to more easily validate Arena for their intended uses and maintain Arena in a validated state.

Arena Validate is a unique offering. Because all Arena QMS customers use the same infrastructure and software, we can continuously maintain the system in a validated state against predefined intended uses. Arena Validate covers installation qualification (IQ) and operational qualification (OQ) requirements of core Arena functionality. Arena Validate also provides performance qualification (PQ) templates, as part of the Validation Setup Packet, to assist customers in determining any additional validation testing needs. If you are a life sciences company evaluating various QMS or PLM systems, you need to know what Arena Validate is and how to compare this robust package to other companies’ validation support.

Already use Arena in FDA-regulated space and don’t yet have Arena Validate? Read about why this package is essential.

To learn more about Arena Validate, we sat down with Alisa Leonovich and Emily Foree.

Alisa is the Senior Manager, Validation and Compliance, at Arena, a PTC Business. In this position, she leads our team of six to deliver Arena’s validation package. She focuses on ways to expand the offering and streamline the work. Prior to Arena, Alisa worked in biological research for a laboratory.

Emily is the Validation Lead at Arena. In this position, she oversees the day-to-day tasks necessary to maintain Arena in a validated state. Prior to Arena, Emily lived and worked in Thailand on a Fulbright Scholarship. She has also traveled extensively by bicycle throughout Southeast Asia and New Zealand.

What are the main components of Arena Validate?

Arena Validate simplifies FDA software compliance. There are three main components:

  • Comprehensive validation documentation package shared with every major and update release
  • Advanced-release notifications containing risk assessment and impact analysis
  • Ongoing support from senior validation experts

Alisa: The documentation package we share with our Arena Validate customers has been developed and expanded consistently for over a decade—starting out with fewer than 100 intended uses, it has grown to cover over 1,400 intended uses today. Most prospective customers who look closely at Arena Validate become customers because they recognize the thoroughness and value this documentation provides.

Emily: Our validation team is always available to address customer questions and concerns, including best practices and templates. One rewarding part of our job is the helpful exchanges we have with our Validate customers, which include candid conversations about their issues and needs.

“Arena made implementation easy by giving us complete IQ and OQ documents. The wide range of standard out-of-the-box functionality narrowed the scope of our work even more. This resulted in a very productive and complete PQ while requiring much less management than other IT system implementations I have been a part of.”

– Ed Reith, Supply Chain Engineering Manager, Ebb Therapeutics

How do you develop the Validate deliverables?

Alisa: We have worked with regulated customers and validation experts to develop a model that addresses customer validation needs. The model—developed based on the GAMP V-model—has been adapted for the cloud-based delivery approach, and integrated into our software development lifecycle process to ensure each new release of the system is internally validated against predefined requirements using the updated and approved IQ and OQ Protocols.

Emily: During a release cycle, we work in parallel with quality assurance (QA) to actively review the scope and product requirements documents (PRDs)—starting early in the release cycle allows us to get ahead of potential validation impact and ensure we adequately cover the upcoming release.

Alisa: Our team has been actively expanding the package so that we grow alongside our customers’ needs. When customers evaluate Arena Validate to decide whether to use our solution or to do it themselves, they often conclude that Arena Validate is the best path after seeing our extensive coverage and the work we do to maintain it.

What is the difference between regular software QA and your testing?

Emily: Arena verification activities (conducted by QA) are independent of validation activities, though many of our processes occur in parallel. Verification testing is performed on all upgrades covered by Arena Validate, as well as on all upgrades not covered by Arena Validate. Generally speaking, verification testing consists of thorough unit tests, whereas validation testing involves user stories—each occurs as separate processes during Arena’s software development lifecycle. Due to these differences (among others), verification testing can cover a wider scope than validation, which is defined by our validation user requirements. A primary purpose of validation activities is to test the software in a way that is closest to how most users of Arena are actually using the software in their day-to-day activities.

We are the final step in the software development lifecycle process before go-live.

Who else do you work with at Arena?

Alisa: We work with almost all teams at Arena—solution architects, account managers, customer success coaches, customer support, quality assurance, product management, and, of course, engineering. We see all the inner workings of Arena. It’s a great vantage point. Sometimes people ask one of us, “I need this, who do I go to?” And we know!

Emily: We also work with customers and future customers to make sure they understand Arena Validate and all it encompasses.

Alisa: The more people understand what we do, they understand how valuable our work is to our life sciences customers. Now, we have validation allies around the company who realize we’re not just a testing bottleneck. They keep an eye out for potential compliance issues.

What are some validation strategies available to customers?                  

Alisa: Customers of Arena have two fundamental validation strategies to choose from. Administrators should choose the alternative that is best suited to Software-Validation-Processestheir business objectives and available resources.

  • Leverage Arena Validate

Arena already executes a set of IQ and OQ validation protocols on the single instance of the Arena system that every customer accesses. Regulated customers may choose Arena Validate to leverage the results of validation as their own evidence for validation.With Arena Validate, customers also receive access to PQ templates. Customers can leverage these templates to determine additional performance qualification (PQ) validation needs.

  • Validate completely internally

A manufacturer’s management team may opt to adopt an in-house IQ and OQ validation strategy.

How long would it take a customer to validate themselves?

Alisa: The amount of time would vary, depending on each customer’s specific intended uses and the complexity of their internal processes. To give some perspective based on our own process, we have a full team responsible for tracking every step of the software development lifecycle. This insider view on the development process and advanced information allows our team to be smooth and efficient—it’s truly priceless.

Performing the validation themselves could also come at great cost from managing large teams or hiring third-party consultants. Companies that are not using multi-tenant cloud architecture like Arena often find it’s so expensive to validate that they resist upgrading their software. One downside of taking that approach is they don’t get new features or even the benefits of the latest software. Over time, they may find themselves using an unsupported software version—which, of course, presents its own risks. Arena gives them all the wonderful advantages of cloud SaaS, and Arena Validate makes necessary software validation easy—the best solution with the fastest path to iterative validation.

Do customers test their own intended uses?

Emily: Many do. We generally recommend that all new Arena Validate customers conduct a gap analysis between their requirements and the requirements that we cover. Identifying gaps and testing for those is much less work than doing it all themselves.

As part of our Validate package, we share the release notes and impact analysis for the upcoming release three to four weeks prior to go-live—this provides Validate customers time to evaluate the scope of an upcoming release to assess the impact to their own intended uses.

Alisa: Non-Validate customers only receive release notes for an upcoming release two weeks prior to go-live.

How do you add predefined use cases?

Alisa: When Arena grows, Arena Validate grows. As new features and upgrades are rolled out, we assess the impact to validation and create new user requirements where necessary. We have also been consistently expanding Arena Validate to cover more Arena products based on customer adoption. Since Validate was started, Arena has grown a lot. Today we maintain 10 validated products covering a wide variety of functionality considered valuable for our Validate customers—security, electronic signatures, access restrictions, configuration, and change control, and much more.

Emily: Once a product is validated, we are more involved in modifications, as the cost of change on a validated product is higher. We assess the proposed changes before they become approved to add to the product.

Emily: We also always welcome customer input—if a customer discovers a gap in our intended uses and notifies us, we thoroughly assess adding new user requirements to cover the gap.

How have things changed since working virtually?

Virtual-Validation-TeamsEmily: In many ways, very little has changed in terms of our process. Arena has always had a number of remote employees, so transitioning to completely virtual communication has been seamless. There has been some loss to working remotely—especially when it comes to dropping in on unscheduled hallway conversations—especially the heated debates! It was a benefit to be able to just insert myself into conversations that could ultimately have an impact on validation. It’s in our customers’ best interest to know what’s going on, and we’re always listening.

Alisa: We playfully refer to ourselves as the “Fun Police”—monitoring every release (even bug fixes) to ensure the Arena system is maintained in a validated state for our Validate customers.

Emily: Since we’ve been working virtually, we’ve had two successful releases—Spring ’20 and Summer ’20. From our team’s point of view, it’s gone very smoothly. It’s more fun seeing everyone every day, but we keep delivering new functionality at about the same pace and certainly the same quality.

Alisa: I noticed that we have more meetings, and they tend to run the full scheduled time. People who didn’t speak up as much are speaking up more because this is their only opportunity. If they don’t speak their piece in that meeting, they might not get another chance. We all have learned to speak up when we have a question to ask or something to say.

Emily: Working remotely allows us to focus more on the specific tasks at hand. We’re more intentional and have more time to focus on specific goals. We have formalized our approaches to existing processes.

Alisa: Overall, it’s been a smooth transition.

What do you like or not like about your work?

Emily: Working in software validation can seem quite boring from the outside, but I really enjoy working at the intersection of product management and engineering—like Alisa said before, we have a great vantage point at the company and get to work with many different teams and functions. This collaboration keeps things interesting for us and pushes us to continuously improve our processes and improve how we communicate the value of validation across the company. I am also motivated by our Validate customers, who are creating truly innovative products. Validation is an important step in bringing these innovations to market, and I really enjoy being a part of that.

Alisa: I completely agree with Emily’s sentiment. Seeing how much the industry and our customers’ needs have changed in the last six years has definitely kept work exciting.

Arena Customer Success Coach Tip on Performance Qualification

Gay Groce is an Arena Success Coach and former Arena Validate customer at a medical device company.  She’s been there and done that! Gay shared this tip for Validate customers who are planning their performance qualification (PQ):

“Since the OQ that is provided in the validation package is so thoroughly documented and executed, use that information to reference in your PQ. Only validate what you as a customer feel is applicable to your business processes. This will save time and resources in documenting and performing your PQ. And you’ll save when you revalidate subsequent releases or add new processes.”

-­ Gay Groce, Arena Customer Success Coach


Wrap Up

At Arena, we continually strive to make product work easier for you. Arena Validate is an example of leveraging our multi-tenant cloud technology plus investing in a validation team for our life sciences customers.

Life sciences companies who use Arena or are considering it should take a close look at Arena Validate. To learn more, contact Arena at [email protected].

Already have Arena Validate and need some help? Contact your Arena Success Coach or Arena Support.

Many thanks to Alisa, Emily, and Gay for sharing their time and expertise.

More reading:
White Paper FDA Software Validation: How Cloud QMS Reduces Costs and Resource Drains