What is Sievers DataShare Elite Software?
DataShare Elite is an intuitive software program that provides a convenient way to manage and store Sievers TOC instrument data in a single repository from multiple sites and instruments. This enables pharmaceutical manufacturers to make faster, more informed, and actionable decisions for their processes, whether monitoring at one location or at various sites across the world. DataShare Elite is available to accompany current Sievers M9, DataPro2, M500, and CheckPoint product lines as well as legacy 900, DataPro900, and 500 RL products. The software facilitates audit reviews throughout the data lifecycle and improves data management.
How does it help TOC customers and their current software needs?
DataShare Elite software eliminates the reliance on removable media devices, such as USBs, to transfer data and strengthens the chain of custody of data and records. The software allows users to import the complete history of an instrument (newer Sievers instruments, as well as, legacy instruments) including calibrations, verifications, and validations along with data, meta data and audit trails. Customizable reports can be exported to any network location in one of six different file types to help facilitate the integration into other data repositories, such as LIMS. A main driver in developing DataShare Elite software was to make it simpler to access and manage TOC data across different sites or multiple instruments – at the same time ensuring data integrity is at the forefront and that the software is extremely easy to use.
What are some unique components that separate DataShare Elite from other software management programs?
DataShare Elite software is very intuitive, very easy to use, and is compatible with Active Directory (AD). This means users can log into the software with the same credentials as their work computer. The software also provides easier management to review audit trails and allows the import of instrument audit trails and software audit trails, as well as maintains its own audit trail to show full chain of custody for all data, metadata, calibrations, verifications, and validation protocols.
Another unique aspect of the software it its ability to import data from legacy Sievers TOC instruments (such as the Sievers 900 with associated DataPro900 software, and the Sievers 500 RL Analyzers), facilitating audit reviews throughout the data lifecycle. There is no longer a need to keep an antiquated computer with an outdated operating system just to store historical data.
What are some current data management challenges and how does DataShare Elite mitigate those challenges?
Data Integrity is of paramount importance in today’s life sciences manufacturing environment. While data integrity guidance is not a new concept, there is increased scrutiny of data, including how data are managed, transferred, secured, and protected.
DataShare Elite Software was designed to meet and exceed Data Integrity rules, regulations, and guidance issued by both government agencies and professional user groups. The software eliminates the reliance on weaknesses such as printing or using USBs in the chain of custody of data and records. Data may easily and securely be passed from a remote instrument, such as the M500 Analyzer, to a secure server without exposing those records to unsecure USB media devices, open file types that could be edited without traceability, accidental loss or deletion, or any other human interaction that could call into question the completeness, consistency, or accuracy of those data and records.
How does DataShare Elite meet/maintain today’s data integrity requirements?
The DataGuard option allows control of data through highly customizable roles with permissions outlined by the user’s organization ensuring 21 CRF Part 11 compliance while maintaining the principles of ALCOA+. This enables users to achieve a high degree of data integrity across numerous instruments and locations. Users can also electronically sign data for online instruments and other Sievers standalone units. This becomes part of the electronic record to support batch record review.
What configurations are available for DataShare Elite, and how easy is it to get started?
DataShare Elite software is available for both enterprise and standalone installations and can be configured in Client-Server, Client, or standalone configurations. The software is compatible with Active Directory (AD) to enable users to log into the software with the same credentials as their work computer. The software easily integrates with current and legacy Sievers TOC instruments, and Sievers support is available to ensure quick and successful implementation.
Tony Saavedra is the Life Sciences Associate Product Manager for Sievers Analytical Instruments, focusing on total organic carbon (TOC) software and instrumentation. Tony began his tenure with the Sievers product line as part of GE Analytical Instruments in 2011 in the field service organization and later held responsibility for leading the North America Technical Services team where he oversaw technical support, factory service, and refurbishment process operations. Prior to his positions with Sievers products, Tony served for 10 years in the US Navy where he supervised flight inspections and performed quality assurance inspections and maintenance of complex electronic radar and communication suites. Tony holds a BS in Electronic Engineering Technology from ECPI University and an MBA from Colorado State University.
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