The Client It was almost a perfect storm: Following their acquisition, a healthcare organization specializing in clinical stage biopharmaceuticals went from robustly dysfunctional to completely non-operational as they struggled to cope with a slew of digital insufficiencies. In fact, for this particular client, everything that could have gone wrong had the potential to do exactly that at any given moment.

From extraordinarily complex technical issues to the usual regulatory compliance conflicts faced by those in the healthcare industry every day, new ownership had every reason to give up completely and abandon what was seemingly a sinking ship. That’s why we immediately jumped on board when they asked us to help them implement a plethora of new operational technologies while simultaneously resurrecting several out-of-operation facilities and growing their number of employees into the hundreds.

The Problem

Alone, any one of the following pain points can lead to a world of misfortune — especially for a business trying to balance so many regulatory priorities with their ambitious plans for the near future.

These challenges were not new to us, but no matter how common they might be, it’s often not until a catastrophe strikes that these issues are identified and taken seriously.

Non-operational Facilities
Careless People, Unaddressed Technical Issues, and Risky Transition Protocol
ELNs: From Scarce Use to Bringing Down the House

The Strategy

By honing in on security and compliance, our team set the table for the success of all of this client’s future initiatives.

Security: Given the number of unreported technical issues and the limited amount of time we had to resolve them, our technicians rolled up their sleeves and began reaching out directly to manufacturers and account managers to both recover and reset access to all sensitive applications and information.
Compliance & Quality Controlled Computing: Today, our team works hand-in-hand with this client and their consultants to ensure 21CFR part 11 compliance. We conduct regular audits to address any issues before they arise and take corrective actions to neutralize existing problems.

The Outcome

Security & Preserved Data Integrity
Technical Issue Reporting
ELN: Return to Prominence

A series of slight oversights coupled with questionable data security can be nearly fatal for a business, especially one in healthcare. But, with the right team of technicians, anyone can recover and get back on their feet.

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Creating Success in the Biopharmaceutical Space by Protecting Data