GxP Lifeline
Integrating EBRs With Its eQMS, BioBridge Global Delivers Products Faster
Over four decades ago, BioBridge Global climbed aboard a fast-moving biotherapeutic industry — never slowing in its mission to save and enhance lives through the healing power of human cells and tissues. As a pioneer in regenerative medicine, BioBridge Global’s health care sector, particularly cell therapy, is highly complex and time-sensitive, which has compelled the organization to circumvent any obstacles to timely product deliveries.
Refined Batch Records
Many of BioBridge’s products go directly to patients, so there’s a high level of urgency in delivering high-quality products. Paper batch records were a stumbling block.
“Some of the batch records we develop can be 400 to 500 pages with over 2,000 to 3,000 manual entry points. Each one of those entry points is an opportunity for failure,” said Executive Director of Global Quality Emmanuel Casasola.
Batch records change hands frequently. Over time, the hand-written entries and corrections become difficult to read. Errors are a byproduct of this scenario. Also, wherever there is paper on the production floor, the probability of inefficient processes, poor data tracking, missing or inaccurate information, and noncompliance to the regulatory requirement for proper record handling is high.
To prevent any of these issues from escalating and impeding its ability to produce high-quality products, BioBridge Global implemented the MasterControl Manufacturing Excellence software solution. The electronic batch record (EBR) functionality has been a valuable asset, especially since it allows the organization to link EBRs to its cloud-based electronic quality management system (eQMS), MasterControl Quality Excellence.
“We have far more controls in place [with] EBRs than with paper batch records,” said Amanda Whitelonis, director, program management at GenCure — one of BioBridge Global’s subsidiary organizations. “You can pull data from it and ensure a person is moving forward with the batch record, and also that they’ve been trained on the process.”
Streamlining Document Access
The EBRs make it easier for staff to track and manage production data. For example, organizations that use biotherapeutic products, such as cell therapies, have to complete many forms that are frequently updated. With paper-based processes, it can be difficult to ensure that the forms are the current versions and that they are routed to the right places in the right sequence. Otherwise, there are delays while the company waits to receive the correct forms. The connected EBR and eQMS solutions eliminate this issue because they allow companies immediate access to electronic versions of the forms.
To learn more about BioBridge Global’s successful digital transformation, incorporating EBRs, an eQMS, and cell therapy software, read the company’s case study “How To Get Products to Patients Faster With a Connected Quality Management System and Electronic Batch Records.” Find out how a partnership with MasterControl has enabled the company to increase efficiency and get life-changing treatments to more patients, sooner.
David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.
