Allergy Therapeutics Gains Increased Flexibility with FirstDoc Upgrade
- Maintain position as industry leader by upgrading FirstDoc document management system
- Define a cost-effective, straightforward upgrade path
- Maintain management control of the upgrade process
- Take lighter, easier, less costly approach in upgrading to FirstDoc version 7
- Engage in user training to increase knowledge of system features
- Leverage CSC’s technology and industry expertise to help facilitate the upgrade
- Cost savings via a lighter, nimbler upgrade approach
- Quicker access to information; improved ease-of-use
- Enhanced system alignment capabilities
A Uniform System
As a leader in the development of innovative allergy vaccinations, it is essential for Allergy Therapeutics to have an up-to-date, efficient document management system to navigate the complex regulatory process.
“As a pharmaceutical company, we are a regulated environment, so we have to ensure that we have robust systems in place where people can access information and have good, tight security and ease of use,” says Pauline D’arcy, IT manager at Allergy Therapeutics. Pauline says automation is another crucial requirement, and as the company expands its presence in the United States, having access to up-to-date regulatory information is more critical than ever. “Previously, no kind of tool existed in the regulatory environment to manage all of the documentation, so one of key advantages is that FirstDoc allows us to put that process into place,” she says.
Ken Herbert, regulatory affairs manager at Allergy Therapeutics, stresses the importance of having uniformity in a regulatory management system, which FirstDoc delivers. “Our entire function is the communication of facts about our company to our regulators, and we need to do that in an organized, controlled and secure fashion,” he says. When it comes to the FirstDoc upgrade, he says, “The new package is providing us with even more benefits than the previous version.”
A More Flexible Upgrade Approach
As Allergy Therapeutics found, upgrading FirstDoc can be much simpler and less costly than it had been previously. CSC is employing a new, agile, cafeteria-style approach to FirstDoc upgrades that gives customers a wide range of upgrade options, varying in complexity and duration. If a light and nimble approach is preferred, CSC can deliver that.
“The upgrade went very, very smoothly,” says Pauline, citing flexibility as a key driver. “What we particularly liked was how we could pick and choose elements of the upgrade we wanted to do ourselves and what would be done by CSC.” She says maintaining a strong level of management and control of the project helped Allergy Therapeutics cut down on upgrade costs.
Julie Gale, regulatory affairs systems coordinator at Allergy Therapeutics, says the upgrade was completed on schedule. “We did it all within the timeline that had been planned out,” she says. Also, Julie says that training provided by CSC has been helpful in getting additional functionality from FirstDoc, especially in the areas of permissions, document management and security.
From an IT infrastructure standpoint, Pauline says an important driver for undertaking the upgrade is that it provides up-to-date compatibility with newer versions of the Microsoft OS and the Internet Explorer browser. “We didn’t want to have our validation systems running on an OS that was no longer supported,” she says. In addition, the new version of FirstDoc decreases total cost of ownership by allowing for backward compatibility; an upgrade can save customers money because they will not have to support older software versions.
Improved End-User Access
The FirstDoc upgrade also improves ease of use. “Straightaway, the upgrade was a win-win situation for the end users,” Pauline says. “When they opened up FirstDoc, it was so much quicker. The speed with which they can access the information — there’s no comparison.”
This greater ease of use serves as an enticement for new users to come on board. Because more users mean higher-quality data, the wider reach of the product is making FirstDoc an even more powerful document management tool. Increased training has also introduced the full functionality of FirstDoc to expert users.
In addition, Julie says FirstDoc has helped streamline the regulatory submission process. “We can now generate and manage all of our regulatory submission documents in FirstDoc rather than some of the submissions being outside, and we are going to see a huge benefit from that,” she says. Now, with the upgrade complete, Allergy Therapeutics is positioned to tap into a more robust, streamlined regulatory information management solution.
Allergy Therapeutics is a pioneer in modern specific immunotherapy, a curative approach in allergic diseases. Like most pharma companies, getting products to market quickly is essential for the company to remain competitive. The upgrade to version 7 of FirstDoc is helping Allergy Therapeutics accelerate the regulatory process even more, by making it easier for the company to adjust procedures and filing practices. Ken says, “We can better align our different end users [with] their accessibility and different functions.”