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Instrument Usage Log Book
Implementing a robust instrument and column usage log management
Log Book
Overview
"In the pharmaceutical manufacturing industry, managing instrument and column usage logs is crucial for ensuring compliance,"
Implementing a robust instrument and column usage log management software helps pharmaceutical companies maintain high standards of quality, ensure regulatory compliance, and improve operational efficiency.
Features
Instrument Usage Tracking
Recording each use of an instrument, including the user, date, time, and purpose.- Monitoring instrument calibration and maintenance schedules.
- Tracking instrument performance and any deviations from expected results.
Column Usage Management
- Logging the use of chromatographic columns, including details such as batch numbers, lot numbers, and usage history.
- Monitoring the lifecycle of columns to ensure they are replaced or regenerated at appropriate intervals.
- Tracking the conditions under which columns are used, including temperature, pressure, and solvent types.
Data Integrity and Compliance
- Ensuring all log entries are time-stamped and user-authenticated to comply with regulatory standards such as FDA 21 CFR Part 11.
- Providing audit trails for all logged activities to ensure traceability and accountability.
- Generating reports for regulatory inspections and audits.
Integration with Other Systems
- Interfacing with Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, and other quality management software.
- Enabling real-time data transfer and synchronization across different platforms and departments.
Alerts and Notifications
- Setting up alerts for upcoming calibration, maintenance, or replacement of instruments and columns.
- Notifying relevant personnel of any deviations or anomalies detected during instrument use.
Data Analysis and Reporting
- Analyzing usage data to identify trends, optimize performance, and predict maintenance needs.
- Generating comprehensive reports for management review and regulatory submissions.
Software Solutions
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Labicon
Offers instrument connectivity solutions and can be customized for logging and managing instrument and column usage.
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V!-Pharma
An integrated solution by Vinfro IT Solutions Pvt Ltd that covers various aspects of pharmaceutical manufacturing, including quality control and instrument management.
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QMS Software
Vinfro’s quality management system which includes modules that can assist in incident tracking and instrument usage logging.
Our Clients
Ciron Drugs
INTAS
Torrent Pharma
Pinnacle
LUPIN
Sri Krishna Pharma
Marksans Pharma ltd
Sun Pharma
Rubicon Reserch
Revenbhel Healthcare
Ciron Drugs
INTAS
Torrent Pharma
Pinnacle
LUPIN
Sri Krishna Pharma
Marksans Pharma ltd
Sun Pharma
Rubicon Reserchr