QAlogbook™ provides a simple and easy-to-use, cost and time saving tool for company wide enforcing and supporting of FDA and GxP compliance efforts in the areas of logbook registrations in all its forms.

The Web-based application utilizes true 21 CFR part 11 compliant electronic signatures, multitiered privilege levels and time-stamped audit trails to ensure data integrity for legal and regulatory purposes, eliminating tampering risks that until now have forced Life Sciences to maintain handwritten documentation of equipment cleaning, maintenance and use.

QAlogbook™ provides the functionality to capture and transform logbook entries into operational intelligence making the data accessible across the organization to a wide variety of users. It replaces the myriad of paper logs, spreadsheets and disparate databases to integrate information from many different sources in one location.

The application enhances the ability of logbooks to act as a source of management information and records key site status information on environment, equipment and other issues to the resources responsible for support and maintenance. Information may be required both, on a daily basis to understand the current equipment condition, or issues and also historically to search for historical events and build up evidence of trends.

The electronic logbook provides the ability to search, view and report on historic equipment data for event tracking and in support of trend analysis. The logbook has a quick and intuitive method to enter data, which ensures that time spent identifying, finally writing logs and capturing operational information is minimized.

Easy logbook Configuration

Whilst providing a mechanism for improved consistency of logs and reports in terms of format, structure and content, QAlogbook™ allows the user complete flexibility in being able to configure log entries of exactly the data needed according to instructions, including text fields, time and date, drop-downs , radio- and check-boxes.

Application Features

QAlogbook™ serves the purpose of effectively replacing traditionally paper-based logbooks. The application has important advantages compared to their paper-based counterparts:

• Web-based easy-to-use interface with Explorer type navigation and Windows style screens
• Single point of data entry
• Shared database, and Multi-site equipment control
• Intensive activity logging for security and full audit trail
• Privilege management, i.e. only viewing and accessing logbooks with right privileges

Key Benefits for Life Science Companies

• Pre-validated application (FDA/GxP). Documentation comes as part of deliverance
• Seamless integration with other QAsuite™ applications
• Configurable logbook layout, i.e. customizable forms, check boxes, drop down menus with pre-defined text, and with enforcement of required fields and the option to upload attachments
• Standardized logbook entries with real-time electronic logbook management (creating and maintaining equipment data)
• Manages electronic reviews and approval process with workflow engine
• Search ability
• Reminders and alerts, i.e. for required data review and follow-up
• Real time statistics on events performed
• Embedded software via IE7 ActiveX control
• One-click to create new logbook entry

System Requirements

• CLIENT: Microsoft Internet Explorer v7.0™, Adobe Reader™
• SERVER: Oracle Database v10g

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