peg-based biotech company Cangene was looking for a few solutions to manage its workplace and process changes, so it went with the Holmdel, New Jersey-based process management software vendor Sparta Systems and its TrackWise suite of workflow solutions and found that it suited them just fine.
Jeffrey Hartrey, Cangene’s director of quality systems and information, said, “We’re a classic pharmaceutical environment in that we generate a lot of paper.” He said that Cangene was after quality management software that would drastically reduce the sheer volume of paper that the company was spewing out on a regular basis.
The pharmaceutical company laboured under strict rules that biotech companies work under. “We’re heavily regulated and bound to product documentation. As a part of that, you get a lot of documentation, with multi-part routing and approval processes,” he said. “Once a company gets to a certain size, it becomes incredibly difficult to manage the distribution and routing of documents. You keep losing things and that’s definitely not a good thing!”
Said Hartrey: “In order to help us manage and efficiently deal with these issues, we looked to get a quality management system to bring productivity and management for paper flow.”
The company considered four or five companies, said Hartrey, before it settled on Sparta Systems’ TrackWise solutions, due to its industry reputation-it has over 300 worldwide installations-and comprehensive training program. Cangene went with the TrackWise corrective action/preventative action and deviation control modules.
As Sparta Systems CEO Ran Flam said, “Our software is a workflow manager that ensures that processes get routed through all the proper steps and reach completion.”
After purchasing the software in late 2005, an infrastructure upgrade was necessary. This was followed by the installation and configuration of the product, which was handled by Sparta Systems, in tandem with Cangene. Hartrey found the solution to be highly configurable. “It was deployed into our workflow at our own pace. It was one of our easier implementations. They more than evolved with our needs,” said Hartrey.
He thought this especially helpful during the phase of implementing all the business rules into the workflow software to ensure that all processes were taken care of and integrated into the solution. “Mapping out workflow (was a challenge). Paper is flexible and is less structured than having to say who did what, and what they should be doing,” said Hartrey. This was made even more confusing, as he had to determine whose desk the control changes were on, and the different tracking systems of all the different departments.
The next step was to launch a few internal pilots. Hartrey said that he was especially pleased to utilize a centrally managed system, which now required users log in change controls and submit them to an approvals process. “This provides an immediate audit trail and searchability,” he said. The system cover a wide range of controls, from equipment to processes to products, and can include documents, protocol, PDF’s, and images. Another bonus, according to Hartrey, is the Web-based aspect of the system that allows users to log in anywhere, courtesy of a thin client. A dashboard-type interface that shows which action is attributed to who ensures ease of use.
With the growing popularity of software-as-a-service, Flam said that his company has begun to branch out into this business model. Two of Sparta Systems’ small business clients are currently taking part in a beta where they are storing their data on Sparta Systems’ databases, instead of their own.
An example of a control change Cangene might log and store on its own server was a change to a documented procedure where an employee wanted to use a new kind of column in a physical procedure. To ensure compliance with the strict regulations governing such changes, the request went through the TrackWise system, ensuring that the appropriate signatures and approvals were appended, and that the comments and history of the transaction were logged for future auditing and records.
Users also benefited from Sparta Systems’ formal training program, which was augmented by a few months of post-deployment support and additional training. A mandatory part of buying the TrackWise solution, Flam said that this training program is a big selling point for his customers. Cangene was so impressed with Sparta Systems’ software that Hartrey plans to implement another one of its solutions in the future: the training module. The regulatory aspect of the pharmaceutical industry means that employees’ safety training, requirements, and experience must be carefully logged, which Cangene currently does through a system of binders. Hartrey plans on implementing the TrackWise training solution so that he can keep track of which employees knows (and needs to know) what, and standard operating procedure changes, as well.