FMS Software Package

FMS Data Integrity and Compliance

With applications spanning sterile product development, quality control, and manufacturing, the FMS series of Headspace Analyzers must meet the current regulatory requirements on data integrity. The FMS software package includes a GxP mode to support the collection of compliant analytical data. A GxP measurement method guides the user through a sequence of steps to calibrate and verify the FMS analyzer before analysis can begin. All raw data and metadata collected during the session are stored according to the method parameters — in a printed report, as an electronic file, or in a secure database. The FMS software package enables full compliance with data integrity regulations while limiting the need for procedural controls.

FMS Software Features

All FMS analyzers are provided with the basic software package, which includes the following operating modes:

• Open offers flexibility when performing measurements that do not require strict compliance
• GxP Print uses predefined methods to collect compliant data in a printed record
• GxP File uses predefined methods to collect compliant data in an electronic data file

The addition of the GxP Database package introduces a fourth operating mode to the FMS software package, bringing enhanced compliance features and centralized data management to the FMS system. Data collected with the GxP Database software is stored in a secure database and accessed from any networked computer through the included FMS Database Viewer software, which incorporates new tools to filter, review, approve, print or export data from a single user interface.

The GxP Database package is available as a software add-on for new or existing FMS systems and includes the following additional features:

• Password-protected software access with multi-tiered user privileges
• Data stored in the secure database can not be modified or deleted
• Results logged to the database at the time of measurement
• Stand-alone database viewer provides access to raw data and batch reports
• Searchable database allows for easy retrieval of measurement data or user events
• Electronic signatures for review & approval
• Complete system audit trail with time & date stamp and user attribution

A comparison of the complete set of features for each software mode is presented in the table below.