GMP Document Management: Pharmaceutical company gains control of their GMP documents with FileTrail

GMP Document Management: Pharmaceutical company gains control of their GMP documents with FileTrail

Client Profile

This client is a leader in the development and manufacturing of therapeutic antibodies for serious health conditions. The company’s product research and manufacturing generate extensive GMP documentation, which is subject to regulatory audits and reviews.

After achieving rapid ROI in the legal department, our client implemented FileTrail to track and manage its work product throughout the complete lifecycle.

“The FDA expects us to present an auditor with any requested document within one hour of the request. We would not be able to do this without FileTrail.” — Technical Analyst, ITS, Business Applications

Background

Like many pharmaceutical companies, our client faced unique and challenging issues with properly managing GMP documents. While many records have transitioned to electronic formats, a significant portion of critical document types are still paper- based and are routinely subject to regulatory compliance, auditing and reporting.

An existing Documentum system managed their electronic documents, but controls for paper-based documents remained largely manual. Each department managed its own data independently in Excel spreadsheets. Ensuring compliance was tedious, risky and labor-intensive.

Our client implemented FileTrail to automate tracking and compliance for over 200 types of physical documents in 16 departments within facilities, quality engineering and quality control.

“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. Our conversion to FileTrail was an outstanding success!”

Automating Compliance

For paper-based records, compliance means strictly control-ling access to the documents, as well as information that describes or relates to the documents. Restrictions must consider the user, department, and type of document, as well as accommodate case-by-case exceptions.

FileTrail’s enterprise-class security gives our client precise control over all methods of access. Permissions control who may view or modify document information, plus who may browse a record within a secured area or check a record out of the secured area.

Permissions are set by User and User Group and utilize inheritance and classification to simplify administration. Item-based permissions provide additional controls over special cases. Permissions are implemented both in file room functionality, repositories and with search and request tools through the browser interface.

Increasing Efficiency

FileTrail automates many processes related to locating or moving physical documents. Common transactions like search, document request, request fulfillment, and re-filing are streamlined. Other processes such as check-in, check-out, archival and desk audits are simplified and vastly more efficient with the use of barcode technology.

Document-handling efficiency depends on platforms and processes that are clear, intuitive, accurate and reliable. Despite stringent regulations, FileTrail end-users find compliance nearly effortless with a high staff adoption rate.

Selecting a Solution

Our client selected FileTrail after an extensive review of alternative solutions. They determined FileTrail’s superiority in four key criteria they established for a solution: highly competent software, great flexibility, vendor domain expertise, and cost.

A defining element in the selection of FileTrail’s solution was competence. The FileTrail platform reflects a solid comprehension of how people actually work with physical documents on a day-to-day basis. Processes are streamlined through automation and controls are implemented without creating additional work for IT or developers.

“Flexibility was key for us. We were concerned about getting buy-in from departments that had been operating autonomously. We had to deal with the differences in data fields and terminology for 200 types of documents. The flexibility of FileTrail helped us minimize the impact and implement a central solution. FileTrail eliminated the need to think about compliance or research every access. The fact that this was done without custom code or programming was fantastic. Files cannot be checked out to staff who should not have them, the restriction is automatic.”

Rapid Transition

FileTrail also performed a Rapid Transition project for our client. The platform’s transition technology quickly converts physical documents to fit automated filing systems and labeling standards. The Rapid Transition project was timed to coincide with training and orientation for over 120 staff. Our Rapid Transition provides a smooth transition for staff and allows clients to begin realizing the benefits of FileTrail immediately. All of our client’s folders, bound lab books, binders and other documents were barcoded and indexed in the FileTrail database in less than two weeks by our implementation team.

Key Benefits

  • AUTOMATED COMPLIANCE: FileTrail maintains and implements compliance rules, preventing accidental violation and risk exposure.
  • INCREASED EFFICIENCY: Easy access to GxP document information saves staff time when locating, requesting and retrieving physical records.
  • PROVEN & RAPID ROI: Automating manual processes and controls presents an immediate and long-term ROI.
  • SIMPLIFIED AUDITS: Produce physical records on demand, reduce the time spent locating documents during audits, and ensure compliance.