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Closing the Compliance Loop

By Kevin Davies

April 12, 2007 | Last fall, Intercell, a Viennese vaccine maker, had to file a submission document with the EU. Pressed for time, the company approached QUMAS, as senior compliance advisor Warren Perry recalls, saying: “ ‘We need a regulatory submission solution and we need it installed, validated and ready with content into an eCTD [electronic common technical document] in 90 days!’ We delivered it, validated it, and they met that deadline in less than 60 days and got the submission out the door.”

Jason Golan, project manager at Intercell, says the QUMAS solution “removed the ‘siloed’ approach to compliance that grows organically in many start-ups, like ours, and needs to be abandoned as life sciences companies emerge from start up mode to full production drug makers.”

Launched in the early 1990s in Cork, Ireland, the forte of now New Jersey-based QUMAS was traditionally quality management systems for life science manufacturing. For years, the company designed bespoke software for big pharmaceutical companies. But no longer.

QUMAS still does content management, focusing on manufacturing, drugs, and devices. Several major biopharmas use QUMAS solutions for IT SOP and GMP manufacturing. “Even today, when a customer wants specific software, document compliance, or process compliance, [their] requirements are taken on board and rolled into general release software,” explains Perry. “We do not have customer specific versions of our software.”

Now QUMAS is expanding into the regulatory realm, particularly what Perry calls tier 3 life science organizations: “That’s a field we’ve been targeting with a regulatory offering,” helping customers produce submission ready forms for an eCTD submission.

QUMAS intends to launch an updated version (5.0) of its software early this year, with new features in regulatory publishing and managing content. Perry says: “It’s a configurable suite of software that closes the loop around anything in the compliance arena that a life science organization needs, so you do not have to go out and purchase a very expensive solution for each compliance initiative.”

This “closed loop of compliance,” Perry explains, means that, “within a single configurable software framework, you buy a suite of software that you can configure for regulatory submissions, CFR21 Part11, Sarbanes-Oxley,... any number of things down the road.”

Flexible Solution
Those needs often include process management, but for companies just seeking to protect their IP and nurture their early-stage R&D assets, QUMAS offers a hosted model that allows clients to store data securely, allowing the client “to deliver those actuals to a Genenetech, Amgen, or whomever [might] acquire the product. You can walk away and recycle your brilliance through your discovery process.”

The hosted model mitigates a problem that many startups have, namely the lack of a true mission critical IT department. This is especially true in California and Massachusetts, Perry argues, where a good IT person could cost $250,000 a year. “It’s the ongoing costs of that human resource to staff a mission critical compliant solution to store their IP.”

In the hosted model, the hardware is taken offsite and hosted by a service provider — Connectria. The client buys the software and hardware, which is maintained offsite, where it retains complete access. Customers also have the option of a delivery model, in which the client buys the software and develops its own IT expertise around it.

Perry says another group of satisfied clients are the venture capitalists. “They’ve never before had secure, inventoriable access to the IP, which is [typically] the only thing that the tier 3 biotech has,” says Perry. It also gives the stakeholders, including the employees, and the actual clinical operations, “a way to know which version of the document is the current one” — an essential part of good business practice.

If the business model changes and the biotech decides to move into manufacturing itself, or build a screening data center, or the IP is acquired, Perry says, “all they do is have their IT people show up, take possession of the 2-3-4 servers, put a few Dell Blade servers into the vehicle, and put them in their own rack. Now they have all that IP, all versions, everything in a very secure auditable inventoriable way.”

The product can run on SQL servers (primarily what tier 3 biotechs go for), Oracle only, or on Documentum. Pricing starts with implementation for 20 users for around $150,000-$250,000. QUMAS has most of its customers in North America, the United Kingdom and Ireland, Scandinavia, Germany, and Italy.

Perry calls the life science sector the “cash cow of our business,” although the size of the average deal in financial services, with customers such as Fidelity, “would have another zero than life science deals.”

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