Empower (software)

History

The impetuses for the development of the chromatography software that would ultimately become Empower were both internally and externally driven. Regulatory discussions led by the U.S. Food and Drug Administration (FDA) within the 1988 time frame centered on the need for an audit trail to track process related procedures in chromatography data systems. The FDA ultimately did not create a regulation addressing this particular issue, but many of these ideas were later solidified in the 21 CFR Part 11 regulations. Concurrent to theses regulatory focused discussions, Waters sought to simplify its chromatography software development efforts. At the time, Waters was developing and supporting three software packages: Expert, Maxima, and ExpertEase. Based on discussions with customers for better management of chromatography data and suggestions by the FDA, Waters undertook a software development project to combine its chromatography data systems into one solution.

A key component of the new CDS platform was an integrated relational database that improved overall data management as well as data traceability. The data traceability functionality would later be instrumental in providing 21 CFR Part 11 safe guards such as audit trails. Empower was the first commercially available CDS to integrate a relational database. Inclusion of a database enabled Millennium integrated reporting and later provided a more robust interface for integrating with other laboratory software packages such as LIMS.

Versions

Expert – 1984

Maxima – 1986 (workstation only)

Expert Ease -1986-87 (Network only)

Millennium V1 1992- Workstation only First commercially available CDS to include integrated reporting. Prior to Millennium, chromatography results were exported to a third party tool for report generation. Functionality included in version 1: custom calculations, reporting, photo diode array acquisition and processing, and system suitability determination. The integrated relational database was a key technology enabler of the custom calculations and integration report generation. This was also the first CDS to operate in a Microsoft Windows environment.

Millennium V2 1994 – The second version of Millennium. Offered a client/server network configuration in addition to the workstation only offering. Version 2 was the first version of Millennium offered as a client/server configuration. Whether deployed as a workstation or client/server network, the installed Millennium shared the same code base, dramatically reducing the software training effort as customer migrated from workstation to client/server network .

Millennium32 V3.0 – 1998-Millennium migrated from 16-bit to 32-bit to provide increase memory access.

Millennium32 V3.2 -1999- Millennium V3.2 offered a complete set of 21 CFR Part 11 Compliant-ready safeguards for the first time.

Millennium32 V4.0 - Released in September 2001—First version of Millennium to support other vendor hardware (Agilent). With the release of version 4, Millennium adopted the Open Instrument Portal (OIP) model for supporting both 3rd party hardware and Waters hardware. The OIP module acted similar to a printer driver and allowed addition of new instruments without the need for rewriting and recompiling the entire code base. All that was required was an updated OIP module.

Empower (Build 1154) - Released in May 2002 – Millennium received a major update and facelift. Empower provided multiple user interfaces, e.g., expert user interface, open access interface, etc. It also added supported for Microsoft Windows 2000. The peak detection algorithms were updated by the inclusion of ApexTrack Integration. ApexTrack integration allowed more automated peak detection and was an important requirement for process chromatography adoption.

Empower 2 (Build 2154) - Released in May 2005 – Empower 2 provided support for Microsoft Windows XP. First CDS network to support mass spectrometry quadrupole detection. Instrument control through the OIP module was dramatically expanded to include xxx instruments. An optional module, called Method Validation Manager, for validating chromatography methods according to regulatory guidelines was added.

Empower 3 (Build 3471) - Released in November 2010 – Latest version of Empower. Designed for the Enterprise and offers certification for virtualization by VMWare and remote desktop access through Citrix. A second aspect of Designed for the Enterprise includes more wide area network support, greater redundancy and uptime capabilities. – Empower 3 provided support for Microsoft Windows 7.