Electronic Batch Record Strategies for Gene Therapy Products
Two things drive progress in this new, vital, but complicated domain; the first is using an automated documentation system that performs in the environment. The second is the expertise to create the initial setup and ongoing adjustments for continued effective operation. These must work together for the benefit of all stakeholders, present and future.
Our last blog demonstrated our InstantGMP PRO system as a capable provider of gene therapy information management. However, software features alone do not ensure effective operation. So, we’ve interviewed Brandy Irons and Kate Martel, our implementation experts, on key considerations for creating and using an effective Electronic Batch Record for gene therapy firms.
Brandy—“In our experience, gene therapy is a double challenge, being both process variable and documentation intensive. With InstantGMP PRO, gene product producers have the option of using the Dynamic Fields Configurator or the Precedent Rule Engine for operation subroutines that variances in growth yields, event timing, etc. could require. Photo files and other key test data can be captured at the applicable batch record work step level. The built-in configurability allows selective reuse of previous EBR entries, potentially saving time. The EBRs themselves can be adjusted (with proper permission) to ensure only the applicable steps require completion. And all EBRs create a .pdf file that captures all events up to the most recent entry.”
Kate—“While gene therapy companies vary from one to the next, they all have a common need to generate meaningful analytics. With InstantGMP, they have a product build engine (the EBR itself) as well as management of PHI (per CDER and HIPPA) connected to production. With the use of our GX Query tool, together they enable powerful investigations into the captured data to reveal product efficacy across a wide variety of patient and health-related variables”.
Kate—“It’s also important to mention that our gene therapy customers work with us to determine actionable setups and even suggest system modifications that would improve their operation. Since we update our cloud-based system quarterly, we can respond with new features without the wait for a major upgrade.”
Here at InstantGMP, we see innovative medicine like gene therapy as increasingly personalized, and our systems design and expertise are well-positioned to assist in its progress. We’re ready to help you tool up and grow for the future of gene therapy.