How To Get Products to Patients Faster With a Connected Quality Management System and Electronic Batch Records

BioBridge Global is the parent company of four subsidiary organisations specialising in biotherapeutic and advanced therapies:

• South Texas Blood & Tissue – Supports all donor-facing activities, recruiting and collecting blood, umbilical cord blood and birth tissue, apheresis products, and life legacy tissue donors. The team supplies blood products to hospitals and emergency service personnel. Other cell and tissue products are supplied to researchers and therapeutic developers across the health care industry, especially in the Advanced Therapies space.
• QualTex Laboratories – Provides high-throughput donor screening for national and international biomedical customers, including blood banks and plasma fractionators. Custom assay services are focused on finished product testing and production facility support (or environmental monitoring for customers in tissue processing and Advanced Therapies).
• GenCure – Manufacturing organisation that provides biomanufacturing services of cell and cell-based biologics for customers in the Advanced Therapies space and collaborates on research and development in support of developing these products.
• The Blood & Tissue Center Foundation – The foundation was established in 2001 and has been responsible for raising more than $30 million in funds to support the lifesaving activities of BioBridge Global and the community.

Going Digital Was a Necessity

During a time of significant growth across all its subsidiaries, BioBridge Global’s paper-based processes were no longer feasible to keep up with the evolving industry and growing customer base. In addition, its on-site and third-party paper storage facilities were filling up and adding more costs. A digital transformation of its operations was the next logical step, so the company implemented MasterControl’s Quality Excellence Solution — a cloud-based QMS.

“One of our biggest initiatives has been to automate as much as possible to increase our capacity and support for our customers,” said Emmanuel Casasola, Executive Director of Global Quality, BioBridge Global. “Normally it would take weeks for [document] handoffs to go through all the stakeholders. Submitting documents and completing approvals through MasterControl, we have a much faster turnaround time.”

Seeing the advantages as well as the time and cost savings from digitising its quality management processes, BioBridge Global desired to extend that benefit to the entire organisation and its customer base, so the company implemented MasterControl’s Manufacturing Excellence Solution — a modern manufacturing execution system (MES). As a result, BioBridge Global is benefitting from organisation-wide connectivity, paperless document management, and faster turnaround times in getting products to patients.

“We use quality as a competitive advantage. Having MasterControl in place oftentimes compels customers to want to do business with us as opposed to somebody else.”

The Need for Efficient Records Management

Given the nature of BioBridge Global’s business, there is a high level of urgency as many of its products go directly to patients. The ability to keep track of records digitally as opposed to on paper gets lifesaving therapies out to patients much faster.

“Some of the batch records we develop can be 400 to 500 pages with over 2,000 to 3,000 manual entry points,” Casasola explained. “Each one of those entry points is an opportunity for failure. Using electronic batch records (EBR) minimises errors, allowing our scientists to focus on the work and not have to worry about entry errors or whether all the information is captured because they’re able to do it all in an electronic system.”

In addition, BioBridge Global’s digital transformation includes having EBRs linked to its quality management system (QMS), which is a valuable asset. “We have far more controls in place in an EBR than with paper batch records,” said Amanda Whitelonis, Director, Program Management, GenCure. “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.”

Quality Is a Top Priority

BioBridge Global is a highly regulated organisation, which means its QMS must adhere to good manufacturing practice (GMP) requirements to maintain compliance. The company meets those requirements using MasterControl. Now, quality has become a competitive advantage for the organisation.

“We get audited once a week around here. We don’t fear audits,” said Martin Landon, CEO, BioBridge Global. “It never ceases to amaze me when auditors come in and say, ‘Your responsiveness during this audit was tremendous.’ That wouldn’t be the case without MasterControl.”

Before MasterControl

“Historically speaking, prior to our implementation of MasterControl, each subsidiary had its own small quality team and its own way of doing things,” said Kevin Rodriguez, Quality Systems Manager, BioBridge Global. “Now we’re able to house all the processes, trainings, and quality events through MasterControl, allowing us to have a global quality entity.”

Rodriguez further explained how the tracking and trending functionality makes it easier to spot errors and even avoid them before they cause delays. This has significantly reduced the overall costs that can accumulate from errors.

Enhanced Customer Service

Prior to implementing MasterControl, South Texas Blood & Tissue had paper requisition forms that customers needed to complete and submit. This involved a lot of time-consuming back-and-forth interaction and faxing documents. If customers didn’t have the most current versions of the forms, the processes were further delayed.

“All those documents are in MasterControl,” said Belinda Flores, Senior Director for Product Management and Customer Relations, South Texas Blood & Tissue. “Our hospital partners can access any form they need at any time, and we can rest assured that it is the correct and most up-to-date document.”

“The overall response from auditors is they’re amazed not only at the speed we’re able to get requested information, but the accuracy and completeness of those records.”

Fast and Easy Implementation

Given the rapid pace of BioBridge Global’s operation, it was imperative that delays and disruption to its business functions for the system implementation were minimal.

“What we found is that with every competitor, we were obligated to change our processes to meet the solution. With MasterControl and its customisation capabilities, we were able to customise the solution to meet our processes. And what this led to was an easier implementation overall. Our operational units really didn’t feel the change was that hard,” said Rodriguez.