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QCMS-FMS

Data integrity and centralized management for raw data from non-chromatographic QC instruments with audit trail and secure backup.

Solution by Webosphere
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Overview

QCMS-FMS is a data integrity solution developed by Webosphere for managing scientific raw data generated by non-chromatographic, standalone instruments used in quality control analysis. It is designed for life science organisations that need to automatically capture, catalog, and centrally store real-time instrument data from multiple standalone PCs across different locations.

The system creates a centralised data repository with a secured environment, enforcing strict controls over how raw data is handled and accessed. It supports audit trail management on a central server and applies backup policies to keep data both secure and accessible.

Core Benefits

  • Transfers scientific data from client or standalone PCs at different locations to a centralised server.
  • Provides a compliance-ready environment for managing an organisation's scientific data and intellectual property.
  • Disables cut, copy, paste, move, and delete operations on native systems without affecting other third-party software.
  • Prevents mishandling of raw data by any user.
  • Captures data from instruments with no PC or operating software via USB or RS232 port, with data viewable by authorised users.
  • Generates and captures reports through a centralised database, saving them in PDF format.

Data Preservation and Security

  • Restricts mishandling of scientific data by disabling cut, copy, paste, and move options on client machines.
  • Maintains a log of actions — including modify, create, and attempted delete — performed on scientific data by analysts, recording timestamp, machine name, and operator or analyst name.

Data Download and Restore

  • Supports download and restore of data with full backup capability.
  • Allows download of a single file or a zipped full backup (with date range) for a specific instrument PC, preserving the original folder structure.
  • Enables restoration in the event of an instrument PC crash or file and folder corruption.

Automatic Data Capture

  • Performs immediate, automatic file backup to the centralised server.
  • Handles data transfer from client and standalone PCs at multiple locations to the central server.
  • Manages file versions based on the number of modifications made.

Online and Offline Audit Trail

  • Manages audit trails on the central server for every action taken on analytical files or raw data files.
  • Tracks audit trail data and performs data backup locally in the event of server connection failures.
  • Automatically uploads data and audit trail records to the server once the connection is restored.

Non-CDS System Data Capture

  • Captures data from instruments without a dedicated PC, such as balances and dissolution machines, via RS232 port.
  • Stores run parameters, run reports, operator name, data acquisition date and time, and instrument name in the database.
  • Allows authorised users to view and review this data at a later time.

Print Capture of Reports

  • Supports printing of reports, results, and chromatograms directly into QCMS with dynamic metadata tags.
  • Saves reports and results in the database as well as in PDF format.
  • Enables searching of reports by tags or PDF contents, with download capability.
  • Provides functionality to create and manage projects, tag templates, and assign tag templates to projects and instruments.

QCMS-FMS is offered by Webosphere Technolabs LLP, a software solutions provider focused on the life science industry. The system is suited to organisations seeking digital transformation and automation of their quality control data management processes.

Meta

Domain
Lab Informatics & Operations
Subdomain
Pharmaceutical GMP Lab Compliance
Software type(s)
Record-Keeping System
Deployment type(s)
On-Premise
Industry vertical(s)
PharmaBiotech
Development stage(s)
Manufacturing
Target user(s)
Bench Scientist / Lab TechnicianLab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11GxP