Advice from a Growing Biotech on Launching a New LIMS within a Virtual Organization

 

Developing an organization’s informatics platform provides a critical foundation for how quality control (QC) data is managed, even for virtual biotechs. There are many different approaches to lab informatics and laboratory information management systems (LIMS), though few address the specific requirements of organizations with outsourced manufacturing and QC. The choices of technology and partner are critical for ensuring a solution that enables better insights from external QC data.

At the recent Veeva R&D and Quality Summit, Cindy Novak, an IT leader with more than 30 years of experience in the biotech and pharmaceutical industries, presented a virtual biopharmaceutical company’s journey to transform quality control (QC). She told a remarkable story that has important lessons for any virtual biopharma considering a fundamental change in how their QC data is managed and analyzed.

Cindy started her story by saying, “LIMS is a four-letter word,” a sentiment that is shared by many quality personnel. While a LIMS is a powerful tool, too many of them operate in legacy ways that lock QC into tired work processes and require users to become experts in data manipulation to get the results they need for analysis. Cindy is an expert in LIMS, having experience with 27 system implementations across her pharmaceutical industry career.

LIMS evaluation

As part of an informatics improvement plan, the stability team drove the need for a new LIMS to replace existing paper-based processes. Cindy’s experience with LIMS vendors and applications led her to believe that providers don’t listen and won’t change. With this in mind, she empowered her team to identify, objectively assess, and choose a LIMS to manage QC data generated by outsourcing partners. They developed a five-step LIMS evaluation process:

1. 1.  Identify top LIMS applications and vendors
2. 2.  Get input from key consultants
3. 3.  Select the top three vendors
4. 4.  Conduct short vendor demonstrations. Ninety minutes should be sufficient.
5. 5.  Select vendor

After the vendor demonstration step, two of the top three vendors backed out of the process. While contemplating going with the last top three option, Cindy was challenged to consider a cloud-based solution, Veeva LIMS.

Veeva surprised Cindy by actually listening to the requirements of her team. They asked questions about the company’s needs and Cindy’s experience. She shared the good, bad, and ugly from her career implementing and supporting LIMS. She also shared the ideas and experiences from her network of LIMS experts. According to Cindy, “It was a very harsh, very real conversation, and I didn’t mince words at all.” 

LIMS selection

Veeva got the same 90-minute demonstration window as the other vendors. That demo demonstrated that Veeva LIMS was the best option for now, and as the virtual biopharmaceutical company grows. Here are the top reasons why:

1. 1.  Right-sized for large biopharmas or emerging biotechs: Delivered the functions a small, virtual biotech company needs today, with the flexibility to scale as companies expand in the future. With Veeva LIMS, biotechs gain an application that is nimble and can scale up or down as business requirements change.
2. 2.  Little to no unnecessary functionality: Didn’t try to sell them things they didn’t need
3. 3.  Approach: Standardized and simplified LIMS
4. 4.  Voice of the customer: Listened to what the priorities are now, and what the company will need in the long term

Cindy summarized the selection process this way: “From a user perspective, the solution doesn’t have a lot of extras we don’t need. This really fits and makes sense to us. They ask questions about the future and if certain capabilities would be helpful for us. That probably made the biggest impression and was the differentiating factor from a user perspective on why we went this route.” Cindy and her team are convinced Veeva is committed to customer success and is the right partner for the long term. 

LIMS implementation project

The virtual biopharmaceutical company set an aggressive goal to implement and validate the new LIMS. Here is the process they followed:

1. 1.  Scoping: Completed scoping calls in advance and then conducted a workshop to hammer out details. The result was a statement of work (SOW) that had ownership from both virtual biopharma and Veeva. The real benefit of the SOW was how well it limited scope creep in the rest of the project. It separated items to be addressed in implementation from items that could be pushed into the future.
2. 2.  Resources: Other than Cindy, the company didn’t have any team members with LIMS experience, and it’s growing. They had one subject matter expert contributing to the team, and he had another full-time role. The company hired a contractor with LIMS experience and benefited from the Services team at Veeva doing some of the heavy lifting for the project.
3. 3.  Master data design: Working with Veeva forced the company to address what they needed from their data. This meant evaluating not just what the data is, but how they wanted the data to function. Constructing a master data design was crucial to standardizing and simplifying the approach. 
4. 4.  Timeline: Set goals and metrics around the delivery of the project. The virtual biopharmaceutical company set aggressive timelines. Due to internal priority issues and heavy workloads, the project was completed a few weeks later than the goal, but still much faster than traditional LIMS implementation and validation projects. They used a risk-based approach for validation, and according to Cindy, “Traditional validations for LIMS take 12 months, and we had a dozen weeks. I think completion was about five weeks late, but we ended up with the validation, and that includes all the documents.”
5. 5.  Communication: Frequent communication across the team and the organization was critical to success. Cindy commented that “Communication is absolutely key. Communication with your partner team is crucial. We spoke weekly, if not more. That communication resolved questions and enabled the flexibility to make needed changes.”
6. 6.  Partnership: Partnership, cooperation, and listening were critical aspects of a successful implementation. Cindy emphasized, “We were very strong partners throughout this entire process.”

A new LIMS, “helps accelerate our mission to enhance and improve peoples’ lives, and at the end of the day, that’s what we’re all here for. Everything I do, everything my team does, is about people,” said Cindy. She continued, “Veeva’s methodology truly does work, and it’s made for a very successful project.” In the end, the project delivered:

• A LIMS designed for the virtual biopharmaceutical company’s current needs that can grow with them in the future
• A complete set of documents for validation and training
• A risk-based validation completed in a very short time
• Access to the Veeva managed services team that understands LIMS implementation
• An agile system that can scale and offer an opportunity to access automation and AI in the future
• Ability to connect LIMS to other Veeva applications in key areas like regulatory management and quality assurance

Scott D. Hanton, editorial director for Lab Manager, can be reached at shanton@labmanager.com.