BioTech Firm Selects FileTrail as Enterprise Records Management Solution for GMP Documents

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Abgenix implements FileTrail's Web-based Records Management solution to track and manage paper-based GMP documents for 15 departments.

FileTrail Inc., the leader in Web-based records management software, today announced completion of a project for Abgenix to automate tracking and legal retention of auditable GMP documents.

Abgenix is a leader in the development and manufacture of therapeutic antibodies for serious health conditions. Headquartered in Fremont, California, the company's product research and manufacturing generate extensive GMP documentation which is subject to regulatory audits and reviews.

According to Amit Syal, a Validation Specialist for Abgenix, "FileTrail allows our quality and manufacturing staff to better manage our GMP documents that are subject to FDA regulation."

Much of the GMP documentation is in electronic form, though a significant portion is paper-based. Abgenix had previously implemented a DM system to manage the electronic documents, but an unfulfilled need remained: the location tracking, central control, audit and legal retention issues related to paper-based records.

FileTrail was selected as the solution by Abgenix after an extensive review of alternatives. Abgenix selected FileTrail because of their need for: 1) a highly competent system, 2) greater flexibility, 3) application expertise, and 4) lower cost.

"I was quite impressed with how easy it was to configure the system to accommodate our very specific needs, including 26 main categories with many types of storage media," said Steven Marks, of the ITS – Business Solutions department.

Managing GMP documents requires a higher competency in accountability and security. FileTrail provides enterprise-class security with Permission settings to control access to sensitive materials. File room automation tools streamline processes while enforcing security settings. Audit trails and field edit histories provide a fall-back, as well as promote accountability.

FileTrail's powerful configuration tools allow each of 15 departments to describe their records their way. The tools are point-and-click - thus, no programming resources were needed for configuration.

A total of 194 categories and sub-categories were defined to reflect the various types of records, each configured to collect a different combination of fields. Precise configuration to each record type simplifies data collection and enhances searching and reporting, ensuring high user adoption.

Another key element in the selection of FileTrail was application expertise. The application reflects a solid understanding of the way people actually work. Processes are streamlined and better reflect the how paper-based records are handled, without the confusion that comes from automating separate paper and electronic disciplines in the same application.

Finally, price was a consideration. The cost of FileTrail was less than that of other systems. The reasons for this are FileTrail's focus on being the best in one discipline and FileTrail's attention to low-cost delivery - providing tools and functionality that ensure implementation doesn't require an army of consultants.

FileTrail also performed a Rapid Transition project for Abgenix. FileTrail’s Rapid Transition technologies quickly transition a client’s paper-based records to fit the newly automated filing system. The Rapid Transition project was timed to coincide with the implementation of the FileTrail software and training/orientation for several hundred staff.

Having all the folders, bound books, binders and other media indexed in the FileTrail database and prepared with standardized labels and bar coding helped the staff make a quick cutover to new, more efficient practices in FileTrail.

“FileTrail helped us make a rapid transition from our old labor-intensive record keeping process to a new streamlined process that saves everyone time and headaches,” said Marks. “Our conversion to FileTrail was an outstanding success.”

About FileTrail

FileTrail, Inc., is a leading provider of Web-based Records Tracking and Management solutions. Companies trust their records management to FileTrail because of great product design, innovative tools, and focus on customer service.

FileTrail's family of Web-based software solutions allows companies to efficiently manage and perform records-related business processes. Clients use FileTrail software to implement file tracking, automate manual tasks, streamline processes, manage inactive records, and apply legal retention policies.

Contact FileTrail at 800 310-0314 or see for more information.

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Darrell Mervau