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.
The Burden of Paper-Based Workflows
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:
Lengthy Manual Processes
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 Connectivity
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."
Management Oversight Challenges
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.
The Search for the Best Solution
Motivated by these challenges, NEXA embarked on a mission to find a digital equipment qualification tool that would address their pain points and revolutionize their operations. The ideal solution needed to:- Streamline qualification processes
- Provide offline functionality
- Facilitate seamless collaboration among geographically dispersed teams
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."
Implementation and User Benefits
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:- Improved Documentation Efficiency: Features like automatic designation of non-applicable fields and pre-populated templates significantly reduced time spent on documentation tasks. According to Revere, time-saving features like this account for a 50% increase in documentation efficiency and enhanced job satisfaction.
- Clear, Error-Free Data Entry: Electronic signatures, timestamps, and date stamps eliminated manual entries and ensured ALCOA+ data integrity. Legibility concerns and errors associated with handwritten records were a thing of the past. This enhanced documentation accuracy and faster turnaround times have contributed to improved client satisfaction.
- Substantial Reduction in Turnaround Times: The ability to access documents remotely facilitated an internal quality review process. This process can now be completed in the same timeframe it previously took to ship physical documents, leading to a four-day reduction in average turnaround time. NEXA’s clients benefit from faster project completion and quicker equipment validation.
- Real-Time Access to Validation Documents: ValGenesis provides a centralized platform for all validation activities. NEXA’s clients appreciate the real-time visibility into validation progress and protocol execution. This transparency fosters trust and empowers clients to stay actively involved throughout the qualification process.
- Offline Execution: The ability to work offline in the ValGenesis mobile app significantly enhances the productivity of NEXA's validation engineers and helps them maintain their schedules effectively, enabling them to take on more projects and increase revenue. In addition, offline mode functionality prevents delays in documenting observations and ensures the accuracy and integrity of validation documentation.
A Transformation Realized
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:
- Reduced project turnaround times by four days on
average, improving client satisfaction. - Increased employee satisfaction through reduced
work hours and elimination of non-value-added
tasks. - Improved documentation accuracy by
implementing an internal quality review process. - Saved @1,500 hours of documentation time when
compared to the previous paper process. - Improved documentation efficiency by 50%.
Unexpected Applications
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."
Future Considerations
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.
