As OpenText™ continues to build strength and momentum in its industry-specific offerings for Life Sciences, we are building our team accordingly. I am pleased to introduce myself with my first blog in the Life Sciences area, taking over from my worthy predecessor, Lori McKellar. Lori’s most recent blog introduced OpenText Life Sciences Express, something I would like to expand on here.
Luckily for us at OpenText – and our customers – Lori continues as a key member of our team. As for me, I’m glad to be back in Life Sciences, a key focus of expertise for me. And I too am excited about this new offering, which I think is a god-send for professionals working in the regulatory management sphere. That’s because Life Sciences Express gives them a huge efficiency boost via mobile access, without concerns about either security or compliance.
Life Sciences Express is a cloud-based application that gives employees and authorized partners easy access to systems of record anytime, anywhere via their device of choice – whether your OpenText™ Documentum™ for Life Sciences repository is on-premises or cloud hosted. An intuitive, role-based user interface delivers only relevant content, with built-in workflows that allow the user to take timely action on critical tasks.
Accelerating time to market? Here’s how
It’s no exaggeration to say that this capability can actually help companies accelerate time to market. Consider these scenarios:
- Senior executives who are needed to perform approvals are often traveling, meeting with team members at other sites anywhere around the world. This often results in delays in approving documents necessary for filing submissions, amendments, extensions, and so on. Missing a filing date can have a huge affect on the potential approval timeline. With Life Sciences Express, approvers can review documents remotely on their mobile device, provide commentary or approve content with a few taps. Life Sciences Express creates workflow tasks to complete – for example, approval requests of CMC summaries or a clinical summary for a specific product.
- Likewise, regulatory managers need to keep tabs on submission compilation progress, and they are often on the road or in the air between sites. With an overview delivered to their device of choice, these professionals can check the status and follow up on critical issues right away, and communicate to upper management as needed.
- Even after a submission is filed with an agency, questions and additional requests often arise that can be handled by functional managers – as long as they have ready access to the correspondence. For example, an agency might request a preapproval inspection that must be addressed quickly. Life Sciences Express pushes these requests via workflow tasks directly to the right individual, who can access the correspondence and other relevant information to take action.
You can see how speeding up these activities can cut days out of the approval process, while making life considerably easier for the regulatory team.
Now let me explain a bit more about how Life Sciences Express safeguards security and compliance. As a lightweight application built on our OpenText content platform, it is an extension to OpenText Documentum for Life Sciences, the system of record. To assure compliance, it captures controlled processes in the audit trail and continues to provide 21 CFR Part 11–compliant electronic signatures, while keeping your high-value content safe.
The fundamental importance of moving to the cloud
I’d like to add a final word about the importance of our move toward the cloud. With native integration to OpenText Documentum for Life Sciences via the cloud, applications like Life Sciences Express support people on the go efficiently and compliantly. And the flexibility of the cloud enables us to continue to build additional purpose-built apps to meet your needs. Finally, as your company evolves toward the cloud, you can maximize your existing investments in on-premise solutions.
If your organization is ready to take a big step toward improving the efficiency of the regulatory management process, you can learn more here.