Transcat Streamlines Equipment Qualification with ValGenesis VLMS

Editor’s note: This blog post summarizes a comprehensive case study about Transcat's 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. 

Pharmaceutical labs are bustling hubs of activity, with an extensive array of research and production equipment spread across various locations. Keeping up with equipment qualification while ensuring compliance can stretch your internal resources thin.

By partnering with Transcat for validation services, you gain access to industry experts who handle the complexities of regulatory compliance, freeing your team to focus on core priorities like R&D. Instead of getting bogged down by qualification tasks, you can accelerate innovation and bring products to market faster.

The Burden of Paper-Based Workflows

Before adopting digital tools, Transcat 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 possible, forcing teams to work overtime and delaying the return of records to clients. This prolonged validation timelines and limited the company's capacity to take on new projects.

Limited Internet Connectivity

Many client sites lacked reliable internet access, making real-time data entry difficult and introducing compliance risks for engineers working under tight deadlines. Delays in recording observations due to poor connectivity threatened data integrity.

"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 Transcat. "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

Strict client policies often prohibited paperwork from leaving their premises, making it difficult for engineers to make corrections or updates. Mailing physical records added costs and introduced risks like document loss and processing delays.

Even with expedited shipping, sending and receiving documents took at least 24 hours. Making corrections and returning updated records extended the process by another three days. Without real-time access to validation records, management struggled to track project progress efficiently, leading to oversight gaps and delays.

The Search for the Best Solution 

• Streamline qualification workflows
• Provide offline functionality
• Facilitate seamless collaboration across geographically dispersed teams

After a thorough evaluation, Transcat selected the ValGenesis Validation Lifecycle Management System (VLMS). The system's offline capabilities, strong industry reputation, and widespread adoption among existing clients made it the clear choice. Many of Transcat'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 

Transcat worked closely with the ValGenesis Professional Services Team to implement the solution across two sites and on-board over 40 users within a 16-week timeframe. Since then, the user base has expanded to more than 100, with continued growth expected. The detailed implementation approach ensured a smooth transition for existing clients and helped drive rapid adoption.

• Improved Documentation Efficiency: Automatic designation of non-applicable fields and pre-populated templates dramatically reduced documentation time. According to Revere, these time-saving features have increased documentation efficiency by 50% and improved job satisfaction.
  
  
• Clear, Error-Free Data Entry: Electronic signatures, timestamps, and date stamps eliminated manual data entry errors, ensuring ALCOA+ data integrity. By replacing handwritten records, Transcat improved documentation accuracy, turnaround times, and client satisfaction.
  
  
• Faster, More Accurate Quality Reviews: With ValGenesis VLMS, Transcat implemented an internal quality review process that significantly improved operations. Quality engineers can now catch errors before they reach clients and complete reviews more efficiently. As a result, Transcat reduced average turnaround time by four days, eliminating lost records and the need for last-minute corrections while engineers are on-site with other clients.
  
  
• Real-Time Access to Validation Documents: ValGenesis provides a centralized platform for all validation activities, giving clients real-time visibility into qualification progress and protocol execution. This transparency fosters trust and keeps clients actively involved throughout the validation process.
   
• Offline Execution: The ValGenesis mobile app's  offline mode enhances productivity by allowing  engineers to execute validation protocols without internet connectivity. This capability helps Transcat stay on schedule, take on more projects, and increase revenue, all while ensuring data integrity and compliance.

Efficiency, Accuracy, and ROI

By embracing digital transformation, Transcat has revolutionized its equipment qualification process, achieving greater efficiency, stronger data integrity, and an enhanced client experience.

Results highlights include:

• Reduced project turnaround times by an average of four days
  improving client satisfaction.
• Increased employee satisfaction by eliminating non-value-added tasks.
• Enhanced documentation accuracy by
  implementing an internal quality review process.
• Saved approximately 1,500 hours on documentation tasks 
  compared to the previous paper-based qualification process.
• Improved documentation efficiency by 50%.

Unexpected Applications 

Transcat has found innovative ways to leverage ValGenesis VLMS beyond equipment qualification. One unexpected application is in the hiring process, where candidates complete a protocol using ValGenesis. This hands-on assessment provides valuable insights into their technical skills, attention to detail, and problem-solving abilities, helping Transcat identify top talent more efficiently. 

"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 

Transcat continues to explore new ways to enhance validation efficiency and collaboration. By expanding its user base, the company aims to further streamline processes and improve cross-team coordination. Recently, Transcat began leveraging the project management module within ValGenesis VLMS to enhance validation project tracking and oversight. Additionally, the team is evaluating ValGenesis Process Manager for cleaning validation, extending its use of ValGenesis beyond equipment qualification.

This blog post offers a glimpse into Transcat's transformative journey with ValGenesis VLMS. For a deeper dive into their success story, read the complete case study.