AmplifyBio

Challenges with a Paper-based System

Before implementing ValGenesis, AmplifyBio used a paper-based system for validating equipment and computer systems that involved many steps and administrative tasks. Capturing objective evidence was particularly tedious. It required the tester to prepare an evidence document, capture the evidence, paste or reference the evidence in the evidence document, ensure that all the evidence was appropriately labeled with the test script and test step, print, and finally sign the evidence document.

Data Entry Errors and Discrepancies

Despite this level of effort, the team still found errors in the manually entered data and instances where evidence had not been authenticated on the same day. These issues compromised compliance and caused bottlenecks. Developing and approving test scripts was equally challenging.

Approval Delays and Poor Collaboration with Test Scripts

Test scripts were previously developed in a Microsoft Word document saved to the project’s folder on SharePoint. Initially, the process required wet signatures, which was cumbersome and time-consuming to manage with a dispersed team. After the adoption of DocuSign, the process for approving a test script remained a multi-step manual process, requiring the tester to download the Word document and then upload it to DocuSign before assigning the author, reviewer, and approver. Once signed, the script and certificate were re-downloaded from DocuSign and re-uploaded to the final validation package in SharePoint. Only then could the script be printed and executed.

“We’re a growing team with multiple sites and an increasing need to collaborate with stakeholders in varied locations. Before going digital, we had instances where completed test scripts and evidence were mailed from the tester, who was based in Texas, to the author in New Hampshire for review, then mailed to our facility in Ohio to be added to the final validation package. As you can imagine, this tedious back-and-forth significantly impeded the validation process.”

Wasted Resources Combatting Subjectivity and Missing Standardization

Lack of standardization was another challenge. In the absence of established protocols, the quality of the test executions relied heavily on the knowledge and experience of the person conducting the test. Stakeholders spent a lot of time addressing repetitive questions, draining time from more valuable work. The presence of subjectivity, particularly when assessing risk, was also a concern.

Stakeholders (or “business owners” as they are called internally) are heavily involved in the validation process at AmplifyBio. They are expected to understand the requirements and explain how those requirements were met during an audit. With 50+ systems and equipment to validate and qualify, invoking process controls to eliminate guesswork and free up resources to solve bigger problems was critical. ValGenesis fit the bill.

“We were looking for a workflow-driven solution to provide the standardization and digital hand-holding our users needed at every step of the validation lifecycle, from system evaluation to archival. ValGenesis is like TurboTax for validation!”

Implementation of ValGenesis

AmplifyBio went live with ValGenesis in 2023. While the actual implementation took only eight weeks, the company was forced to pause twice: once to redirect resources to tackle growth spurts and business priorities and a second time to refresh their existing CSV process rather than automate what had become flawed procedures.

“We knew there were some gaps in our existing validation program. Rather than digitize a flawed process, we decided to redo our SOPs before moving forward,” explained Hesson, who served as AmplifyBio’s implementation champion and primary SME.

One such gap was how to proceed when a test execution does not go as expected. The legacy practice was to talk to the test script author, but that was ad hoc and subjective. Working together, the ValGenesis/AmplifyBio team configured a controlled process for handling these “exceptions” based on risk, as assessed by both the tester and the author. This brought much-needed clarity and peace of mind to all parties.

“The ValGenesis Professional Services Team was as patient as could be. The number of starts and stops we had would have frustrated anyone, but they were able to jump right back into the project as if no time had passed ― and come up with innovative solutions to every configuration challenge we threw at them."

“Before the on-site user training, we collaborated with Eliot Davidson [a Senior Business Analyst at ValGenesis] to customize a training plan based on the roles we created in the system. This allowed us to present only relevant information to the SMEs. We were also able to record the training sessions and then break them into smaller, more digestible segments we can assign in our quality management system to new users based on their role.”

AmplifyBio was so impressed with the ValGenesis Professional Services Team that the company awarded Davidson its On the Spot Award. This honor is typically reserved for employees who consistently exceed expectations, making Davidson the first recipient from outside the company to be recognized with this esteemed accolade.

AmplifyBio staff and ValGenesis business analysts Eliot Davidson celebrating go-live.

Process Improvements That Put Hours Back Into the Day

According to Hesson, after implementing ValGenesis, users immediately noticed several process improvements and the elimination of some of the challenges they struggled with in the past.

Timely Turnaround for Document Approvals

The number of steps involved in the document approval process went from four to two, a significant 50% efficiency gain. Collaborating, reviewing, and approving a document all in one system has been a time-saving game changer.

Capturing Objective Evidence in a Single Step

“Before ValGenesis, capturing objective evidence was a long-drawn-out process. We had to take a screenshot; paste it to another document; make sure it was labeled with all the important information, such as the test step and test script; print it out, and then sign the physical document,” said Hesson. “With ValGenesis, we just take a screenshot ― that’s it!”

Fewer Audit Findings

Hesson anticipates that ValGenesis will effectively eliminate audit findings related to documentation errors, which previously comprised about half of all findings. Examples include manually updating template information and metadata, timely authentication of objective evidence, and unclear tester identification for split test executions. Implementing the automated report generation feature is expected to significantly decrease similar findings in the validation summary reports.

A Streamlined Process for Audit Submissions

“Our previous process for submitting audits was to ensure all electronic documents and their DocuSign certificates were gathered and organized on SharePoint, and paper documents were gathered and organized in a binder. We would then submit the binder and SharePoint link to QA for audit. With ValGenesis, all validation artifacts are created, approved, executed, audited, and archived within one system. It’s so much more efficient – and safer, too. We don’t have to worry about someone accidentally deleting a critical document, which can happen on SharePoint.”

Easier Collaboration with Remote Colleagues

“Completing a validation with a remote team has been much more efficient with ValGenesis. All collaboration, from authoring to archival, can be done in a single platform. Our remote users love it!”

Assessments with Built-In Logic

GxP assessments were previously performed on paper and included instructions to skip to specific questions or sections based on user responses. Getting through it was tedious and time-consuming. With ValGenesis, this logic is built in, which saves considerable time and frustration. According to Hesson, “Now, when we walk colleagues through the assessment process, they say, ‘That’s it?’”

Plans for the Future

ValGenesis helps AmplifyBio reduce the administrative time and busy work that comes with validation, allowing them to focus on tasks that impact the business as they branch out into new therapeutic areas. Users appreciate the efficiency gains, and stakeholders are keen to expand usage into other departments, such as CQV and facilities/site engineering, as part of the company’s strategy to modernize its technology landscape.

“By reducing the validation time of our systems and equipment, we can quickly implement new capabilities to meet the needs of our upcoming studies and projects. Partnering with ValGenesis showcases the maturity of our CSV program, which will appeal to our sponsors and regulators, while demonstrating our dedication to expediting the development of modern therapeutics for patients eagerly awaiting them.”