NEXA | EAM

Pain Points of Paper-Based Equipment Qualification

NEXA’s decision to go digital was fueled by critical operational challenges, including:

Lengthy Manual Processes

Paper-based methods were inherently time-consuming. Engineers faced the arduous task of manually documenting qualification activities, collecting data, and compiling reports. If the documentation was not completed on-site, the engineer would have to finish it off-site, often working over the weekend, and ship the qualification binder back to the client. Prolonged validation timelines increased the risk of project delays and limited the company’s capacity to take on new projects.

Challenges were amplified during large-scale projects like warehouse mapping initiatives. These projects spanned multiple sites across numerous states and required extensive data collection, with more than 300 data loggers recording hundreds of pages of temperature and humidity readings per site. Managing such vast quantities of paper was impractical and time-consuming, posing a significant obstacle to delivering services efficiently and within the required time frame.

Limited Internet Connectivity

The nature of the company’s work frequently required qualification activities to be executed in areas with limited or unreliable internet connectivity. This lack of reliable internet access at client sites posed a risk to adopting a paperless validation system. Waiting to record their observations until Wi-Fi access was restored would leave them vulnerable to data loss, human error, and data integrity violations.

"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 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 that prohibited paperwork from leaving their premises. This restriction posed a dilemma for the engineers, especially when corrections or updates were necessary. For clients without this restriction, mailing hard copies introduced other disadvantages, such as unwelcome costs and the risk of document loss and delays.

Even with expedited shipping methods, such as next-day air, 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 processing time of three days. The turnaround timeframe could stretch further if engineers were already engaged in validation activities at other client sites. Ensuring comprehensive oversight of all corrections and updates proved daunting. This lack of direct oversight hindered management's ability to track the progress of qualification projects accurately and efficiently.

"The hard copy is the original record, and our clients own those. If a client misplaced something, they would ask us for a copy of what was executed. At best, we would have a scanned copy of the executed protocol along with our attachments and supporting data. We could reprint everything and reproduce the binder to the best of our ability, but it's still not the original record," said Revere.

The cumulative effect of these limitations rendered NEXA's paper-based workflow increasingly unmanageable. The sheer volume of paperwork, combined with the intricacies of compliance requirements and client policies, strained resources and processes. Despite efforts to maintain meticulous records, discrepancies and delays in documentation were unavoidable, undermining the efficiency and integrity of validation operations.

Implementation and Adoption

NEXA worked closely with the ValGenesis Professional Services Team to determine the project scope and map a 16-week implementation schedule to deliver ValGenesis VLMS to two sites (US and Canada) and 40 named users. Revere describes the implementation process as "organized and detail-oriented."

"I didn't think implementation would take the full 16 weeks, but it did," admitted Revere. "That speaks to the robustness of the system and thoroughness of the ValGenesis implementation team. They were truly invested in our success and sought to create a digital workflow that emulated our established hard-copy processes. This enabled a smooth transition for our current clients."

Bespoke training sessions were recorded to create a video library for future reference and employee training purposes. These videos have been integrated into the company's standard processes. In addition, NEXA can use ValGenesis University, ValGenesis’ platform for self-paced and instructor-led courses to simplify user onboarding and provide ongoing support for continuous education and improvement. This resource is particularly valuable for quickly familiarizing new hires with the system, thereby lightening the training responsibilities of the ValGenesis system administrator.

Since mastering the initial learning phase of the new system, users have enthusiastically embraced its adoption. The user base has more than doubled to over 100 users, and more are planned for this year.

Leveraging ValGenesis: Key Features and Benefits

NEXA's adoption of ValGenesis yielded immediate benefits, including:

Improved Documentation Efficiency

Good documentation practices stipulate completing all fields on a record, even if they are not applicable. This ensures the record cannot be added to later without appropriate review and approval. It also indicates that not completing a field/space is deliberate.

Before incorporating ValGenesis into their workflow, NEXA's validation engineers had to painstakingly scrutinize each page of a document, manually indicating non-applicable fields as "N/A" and initialing and dating them to uphold the record's integrity. The process was laborious and time-intensive; a single document could span over a hundred pages.

"In ValGenesis, a prompt asks if you want to designate unexecuted fields as N/A. Click 'yes,' and this action is instantly applied throughout the document. What used to take us an hour takes a few seconds. It's a feature we absolutely love," praised Revere.

According to Revere, time-saving features like this account for a 50% increase in total documentation efficiency and enhanced job satisfaction.

Clear, Error-Free Data Entry

"Legibility concerns were a common problem when delivering hard copy qualifications that were documented using pen and paper. And simple, common mistakes like accidentally writing 2023 instead of 2024 after the year change are a big deal in a regulated industry. With ValGenesis, date attributions will always be correct, and legibility problems are solved," said Revere.

Features like electronic signatures, timestamps, and date stamps help NEXA maintain compliance with regulatory standards. Eliminating handwritten entries means all data captured adheres to ALCOA+ standards. Enhanced documentation accuracy and faster turnaround times have contributed to improved client satisfaction.

Substantial Reduction in Turnaround Times

The ability to access executed documents remotely via ValGenesis has helped NEXA implement an internal quality review process. This has profoundly improved operations. Quality engineers perform an internal review that can catch errors before they reach clients and complete the entire review process in the same amount of time it would have taken to ship the physical documents. This has led to an average reduction of four days for turnaround time and eradicated the issue of lost records or engineers having to scramble to make corrections while engaged at other client sites or over the weekend.

The company employs a systematic approach to quality review, assigning points to errors based on their severity and utilizing a comprehensive checklist to verify the accuracy of the documentation. Peer reviews and formal sign-off processes ensure that all quality checks are conducted meticulously, resulting in a higher quality final deliverable for their clients.

Additionally, NEXA generates internal quality notices to address common errors and prevent future occurrences. By striving for perfection in their documentation, the company aims to uphold the highest standards of quality and reliability in their qualification services, building and reinforcing credibility with clients.

“There is a night and day difference between prior state and current state since implementing internal quality review,” noted Revere. “And ValGenesis absolutely deserves credit for being the tool that enables us to collaborate and operate the way we do.”

Real-Time Access to Validation Documents

ValGenesis provides a centralized platform for all qualification activities. Clients appreciate the real-time visibility into protocol execution, which facilitates communication and collaboration between the validation team and client stakeholders.

"Now, the final deliverable we give our clients is a single PDF, not a bulky binder ― or binders. The summary report, execution protocol, and all the attachments are hyperlinked. It is easy for clients to review and to share with auditors," said Revere.

Offline Execution

The ability to work offline in the ValGenesis Mobile App prevents delays in documenting observations and ensures the accuracy and integrity of validation documentation. It also helps NEXA's validation engineers manage their tight schedules effectively, enabling them to take on more projects and increase revenue.

Unexpected Applications

NEXA has discovered innovative ways to leverage ValGenesis beyond its intended use, such as candidate screening during the hiring process.

The hiring team provides job candidates with a fully executed protocol, as an example, along with basic instructions. Candidates are then assigned the same protocol in its unexecuted state and tasked with completing it using ValGenesis. This simulation serves as a practical test of candidates' ability to comprehend new software and follow instructions accurately.

During the simulation, candidates are expected to navigate ValGenesis independently, executing each protocol step with precision and accuracy. Their proficiency in using the software to document validation activities in real time is assessed, providing insights into their technical competence. The manner in which further guidance is requested correlates to how they will approach future stressors of the role.

As candidates progress through the protocol execution, their attention to detail and problem-solving skills are put to the test. Any deviations from the prescribed procedures or errors in documentation are noted, offering valuable insights into candidates' ability to identify and rectify discrepancies effectively.

The duration candidates take to complete the protocol execution is also measured in ValGenesis, providing valuable feedback on their time management skills and efficiency. Candidates who can work methodically and effectively meet deadlines are more likely to execute validation tasks within stipulated timeframes successfully.

"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. "A bonus is that when hired, they already have some experience using the ValGenesis system and have familiarized themselves with our qualification protocols."

Future Considerations

By expanding their user base, NEXA aims to streamline validation processes further and improve collaboration across teams. They are now utilizing the project management module within VLMS to enhance the management and tracking of validation projects. Additionally, they are keen on exploring tools like ValGenesis Process Manager for cleaning validation to broaden their usage beyond equipment qualification.