Pressure to bring new products to market faster has never been greater. At the same time, records and information management are growing more challenging by the day. Isn’t it time you upgraded your records management system?
For research-based pharmaceutical and biotechnology companies, effective records management plays a critical role in every stage of the product lifecycle — from R&D and clinical trials to regulatory approval, manufacturing, quality assurance, and sales and marketing.
FileTrail modernizes records management. We’ve worked with leading pharma and biotech companies, as well as the FDA, providing solutions that streamline the way organizations can manage not only their physical records but also their electronic information.
FileTrail Helps You Comply
FileTrail GPS unifies management of physical and electronic records, supporting GxP and regulatory compliance by enabling Records, Quality and Information Management teams to:
- Search and Locate Physical Records More Efficiently
- Control Access to Physical and Electronic Documents
- Document Chain of Custody
- Streamline Audits and Reporting
- Manage Retention Across Electronic and Physical Records
FileTrail automates compliance by maintaining and implementing compliance rules, preventing accidental violation and risk exposure.
FileTrail increases efficiency by providing easy access to GxP document information, saving staff time when locating, requesting and retrieving physical records.
FileTrail delivers proven, rapid ROI by automating manual processes and controls, presenting presents an immediate and long-term return on investment.
FileTrail simplifies audits by producing physical records on demand, reducing time spent locating documents during audits, and ensuring compliance.
“FileTrail reduced the time it takes to retrieve a file by 90%, ensuring that attorneys have quick and timely access to documents and information.
“Now, FileTrail makes it easy when we need to find all relevant agreements for a financial audit. Anyone can gather the information – not just someone who has worked on that project.
“Since we implemented FileTrail, we have greater control over all our paper-based records. FileTrail has helped us find every file and document, and we have not had to request a copy from any external parties.
“FileTrail lets us define any number of fields on the screen. This allows us to store our own internal tracking number for patents, in addition to the application number, patent number and publication number.”
— Legal Administrator, Fortune 500 Biopharmaceutical Company
“For each country our products are registered in, we track their expiration dates. Hundreds of Ultradent product registrations expire every month. As an organization, we need to be able to budget for those expirations and anticipate expenses throughout the year. With a reporting tool that lets us pull up this data, FileTrail has become a key part of our internal forward planning.”
— Regulatory Affairs Specialist, Ultradent
“We needed a state-of-the-art system that allows real time tracking of files, and is scalable, flexible, and highly user-definable. FileTrail has given everyone the ability to track and order their own files and documents. The one-click movement of files between users and locations is a huge time-saver for the vault. We have seen a 30 to 40 percent savings of labor over our old system.”
— File Vault Team Leader
Client Snapshot: Ultradent Streamlines Regulatory Compliance with FileTrail
Datasheet: for Biotech and Pharma Companies
Client Snapshot: Scaling Globally with Top Pharmaceutical Firms
Case Study: GMP Document Management