Global Pharmaceutical Company Selects FileTrail To Improve Quality Systems And Regulatory Compliance
RFID Technology Enhances FileTrail's Software for Tracking and Compliance
FileTrail announced the implementation of its industry leading records management solution with RFID by a global pharmaceutical company. FileTrail's records management solution will be used to automate compliance and tracking of a broad array of items ranging from FDA regulated documents to archived records to biologics, such as tissue samples. The ability of FileTrail's solution to meet the strict requirements to manage both physical records and biological assets was a determining factor in the decision.
There were a number of key factors for FileTrail being selected in a competitive review. One of these was electronic signature capture -- a 21 CFR Part 11 requirement. FileTrail fulfills this requirement with an industry-standard implementation, offering a reason code to select as well as entry of a more detailed explanation.
"FileTrail delivers a true Quality Systems improvement in a GXP regulated environment," said Steve Marks, a system architect at FileTrail with BioPharma expertise. "FileTrail streamlines the drug development process and will be fully validated due to the critical function the system serves in operations."
The RFID technology from FileTrail is being implemented in many areas to track and manage IP assets, lab notebooks, and traditional file folders. For example, in Drug Safety, FileTrail inventories and manages tissue samples. The power of FileTrail RFID is that it allows tissue samples inside boxes to be audited without the need to break the seal on those boxes.
The client has found a number of unique capabilities in their FileTrail system that will improve their auditing and quality system requirements. First, FileTrail leverages a single database globally, providing centralized oversight. Global clients also benefit from localization, allowing staff in each country work in their language of choice. In addition, FileTrail's browser-based technology ensures global access and provides a clear, intuitive interface.
Another unique capability in FileTrail is the ability to use RFID, barcode, or both. Because FileTrail was architected with separate unique identifiers for barcode and RFID, clients have the option to choose which technology is appropriate in each application. For example, this client will use RFID in its Irvine, California office while the lower-volume operations in France and Germany will use barcoding exclusively.
The first phase of implementation includes offices in the US, UK, Germany, and France. Later phases will cover more locations globally.
The Client is a technology-driven Pharmaceutical - health care company pursuing therapeutic advances to help patients live life to their fullest potential. Origins in eye care, but neurosciences, medical dermatology and urologics are also structured under the company's pharmaceutical business portfolio. They are best known for the success of their products in cosmetic/aesthetic therapies.
SOURCE: FileTrail