Editor’s note: This blog post summarizes a comprehensive case study about NEXA | EAM, a Transcat Company, and their successful implementation of ValGenesis VLMS to enhance their equipment qualification process. Please click the link at the end of this post to access the full case study. Click here to learn more about NEXA's enterprise asset management solutions.
Pharmaceutical labs are bustling hubs of activity, with an extensive array of research and production equipment spread across various locations. Validating and managing these vast inventories efficiently requires specialized expertise and resources that may not be readily available in-house or may be needed elsewhere.
By entrusting equipment qualification to NEXA, life sciences companies can tap into a wealth of experience and industry knowledge, ensuring that regulatory standards are met without the burden of handling every aspect internally. This allows them to redirect their focus and resources toward core activities like R&D, driving innovation and speed to market.
Before embracing digital tools, NEXA relied on a paper-based approach to equipment qualification. This method came with several drawbacks that significantly impacted operations, such as:
Validation engineers spent countless hours meticulously documenting activities, collecting data by hand, and compiling reports. Completing documentation on-site wasn't always feasible, leading to overtime work and delays in sending documentation back to clients. This prolonged validation timelines and limited the company's capacity to take on new projects.
Limited internet access at client sites hindered the company's validation activities, leading to productivity issues and compliance concerns for engineers operating on tight schedules. Delays in recording observations due to unreliable Wi-Fi exposed them to data integrity risks.
"ALCOA stipulates that data be contemporaneous, meaning we must document what we observe when we observe it, not jot down what we see on a sticky note, which will become part of the permanent record, and re-document it later once we're back online," said Jonathan Revere, Director of Validation at NEXA. "We knew we needed a digital solution that would allow our engineers to execute validation protocols seamlessly, regardless of internet availability. The fact that ValGenesis offered an offline app was a huge competitive differentiator and a big part of why we chose them."
Some clients enforced strict policies prohibiting paperwork from leaving their premises. This restriction posed a dilemma for the engineers, especially when corrections or updates were necessary. Mailing physical copies introduced additional drawbacks, such as added costs and the risk of document loss and delays.
Even with expedited shipping methods, there was a 24-hour delay from shipment to receipt. Implementing the necessary updates and sending the record back to the client usually resulted in a three-day processing time. Ensuring comprehensive oversight of all corrections and updates proved daunting. This lack of direct oversight hindered management's ability to track the progress of validation projects accurately and efficiently.
Following a thorough evaluation, they selected the ValGenesis Validation Lifecycle Management System (VLMS). ValGenesis' offline capabilities, reputation within the industry, and existing familiarity among their clients were key factors in their decision. Many of NEXA's larger customers were already using ValGenesis for other validation activities.
"The majority of our work comes from repeat business, so we know the value of having an excellent reputation," said Revere. "Clients trust the name ValGenesis, and that really benefits us."
NEXA collaborated closely with the ValGenesis Professional Services Team to implement the solution across two sites and onboard over 40 users within a 16-week timeframe. The user base has since expanded to over 100, with continued growth expected. The implementation was praised for its detail-oriented approach, ensuring a smooth transition for existing clients.
The adoption of ValGenesis yielded significant benefits for NEXA, including:
By embracing digital transformation, NEXA has revolutionized their equipment qualification process. They've achieved remarkable efficiency gains, improved data integrity, and enhanced the overall client experience.
Results highlights include:
NEXA has discovered innovative ways to leverage ValGenesis beyond its intended use for equipment qualification. For example, they now utilize the platform to assess candidates during the hiring process. Job hopefuls are tasked with completing a protocol using ValGenesis, providing valuable insights into their technical skills, attention to detail, and problem-solving abilities. This innovative approach streamlines the hiring process and helps NEXA identify top talent.
"This technical challenge has been a great screening tool for us, especially when it comes down to two candidates with equivalent resumes and interviews," said Revere. "An added bonus is that when they are hired, they already have a bit of experience using the ValGenesis system."
By expanding the user base, NEXA aims to streamline validation processes further and improve collaboration across teams. They have recently begun utilizing the project management module within VLMS to enhance the management and tracking of validation projects. Additionally, they are keen on exploring tools like Process Manager for cleaning validation to broaden their usage beyond equipment qualification.
This blog post provides a snapshot of NEXA's transformative journey. For a deeper dive into their success story, read the complete case study.