Life Sciences

Problem

Life Sciences organizations are facing increasingly stringent regulatory requirements for their operations processes in the manufacturing and quality areas. Many organizations have DM systems to manage electronic documents and automate business processes for GMP, GCP and GLP.

The focus on DM and going electronic has left remaining paper-based records without efficient and effective controls. The result is less control over paper records, labor-intensive enforcement of security rules, and a high risk in meeting requests for paper documents during regulatory audits.

Solution

FileTrail helps life sciences organizations streamline business processes, reduce exposure to risk, enforce compliance, and respond within an hour to requests for auditable records. As a result, staff spend retrieving and handling paper-based records. Staff time is freed for mission tasks, while managers have more time for people and projects.

FileTrail provides organizations with rapid access to information which enhances decision-making and helps bring them closer to compliance with prevailing laws and regulations such as 21 CFR Part 11, HIPAA and the Sarbanes-Oxley Act. Security rules are automatically applied to control who may search, view, modify, request, browse or check-out paper records.

Benefits

FileTrail compliments your existing DM system in key areas:

• Compliance - Manage and control paper-based GMP documents
• Efficiency - Save staff time in requesting, locating and retrieving paper-based records
• Economics - Automate traditionally manual business processes for a quick ROI
• Exposure - Apply rules to control who may access paper-based records
• Audits - Reliably produce paper-based records on demand and breeze through compliance audits

Features

Key features of the FileTrail solution for Life Sciences include:

• Easy-to-use browser-based user interface
• Unlimited user-definable fields, searches, labels, and reports
• Highly-configurable interface results in high-user adoption and time-savings for all staff
• Audit trails to prove authenticity and meet legal and regulatory requirements
• Litigation support tools to provide destruction freeze/holds across media boundaries
• Automated records retention & disposition capability
• Electronic integration with off-site storage vendors
• Configure and manage multiple file rooms and storage sites in multiple office locations across multiple jurisdictions
• Consistent application of retention policy regardless of media
• Streamlines the search, request, retrieval, and delivery process
• Integrated one-click email communication about circulating files
• Provides complete security sub-system controlling access to functions and records information
• Integrated security leverages Windows authentication
• Pure Web n-tier, scalable browser-based thin client architecture
• Fully integrated bar coding, color coding and RFID technologies
• Google-style location mapping for retrieval and delivery of hardcopy records