The unique nature of regulated industries presents a separate set of challenges for the businesses involved. Life science and pharmaceutical companies must meet specific requirements laid out by regulating agencies like the Food and Drug Administration (FDA) or the International Organization for Standardization (ISO). Failure to meet the stringent requirements associated with regulated industries can result in catastrophic consequences that may include fines, plant closings, and lost revenue.
Calibration software that assists regulated industry professionals in maintaining the proper working condition of their assets is critical in avoiding these consequences. Datastream 7i's flexibility allows for reliable life science and pharmaceutical asset management, as well as for proper management of assets in other regulated industries. To Contact us to learn more about our advanced calibration software, or follow this link to download a brochure and explore the many Datastream 7i calibration software capabilities.
Life Science Asset Management & Calibration Software
The life science industry maintains a special need for efficient asset management. Life science asset management software can help reduce costs, increase efficiency, and utilize calibration software to aid in regulatory compliance. This can have a profound impact on a company's bottom line. Datastream 7i calibration software allows customers to track, manage, and extend the life of critical assets. The flexible nature of Datastream 7i provides life science companies with an asset management solution that can help:
- Comply with 21 CFR 11 regulations and ISO standards
- Improve operational productivity and processes
- Increase both equipment and staff productivity
Calibration Software Features of Datastream 7i
Life science businesses rely on the stability of their equipment, instruments, and processes and use calibration software to maintain this stability. The proper calibration of assets is critical to meeting the precise requirements of regulatory agencies like the FDA and ISO. The Datastream 7i Calibration software advanced module is designed to make meeting these requirements more efficient. With it, customers have the ability to:
- Test for compliance with ISO 9000, FDA, JCAHO, and other regulations
- Integrate calibration data with other business areas
- Distinguish between instruments and their positions to allow the tracking of replacements
- Track calibration costs
- Access the system remotely through mobile capabilities and replace paper log books
Effective calibration software is also important in manufacturing . Proper calibration and upkeep of plant equipment and other assets in the manufacturing industry is often required by the EPA or a company's own internal self-audits. The calibration software module of Datastream7i provides for specific capture and label categorization for inspections, self-audits, spill reports, and all safety related matters. Proper calibration can also help minimize maintenance related downtime and turn-around time, and improve plant productivity.
Pharmaceutical Asset Management
The audit trails and validation capabilities of Datastream 7i are essential to precise pharmaceutical asset management. FDA regulations require that pharmaceutical companies accurately document their practices, systems, and equipment and provide the FDA with that documentation. Tracking, maintaining and recovering that amount of data manually takes countless man-hours. For a more reliable, efficient pharmaceutical asset management solution, companies turn to Datastream 7i to:
- Provide auditing tools to guarantee quality and safety
- Track selected entries, changes, and deletions
- Compile complete records with snapshots of all related functions
Pharmaceutical asset management also includes the validation of technology-based systems before they are deployed. This validation serves to prove that the system operates as it was designed and configured to. Due to its industry-leading security, stability, and flexibility, Datastream pharmaceutical asset management software has been validated by leading pharmaceutical companies throughout the world. As an added advantage, we have developed a strong partner network of validation experts that are available to assist customers throughout the process of validation. Download a brochure, or continue browsing this site to learn more about pharmaceutical asset management solutions from Datastream (now Infor).
Datastream 7i: Calibration Software Capabilities
Much more than a computerized maintenance management system (CMMS) or enterprise asset management (EAM) software, Datastream 7i gives customers the tools to go beyond these capabilities. Customers can track and manage their assets, and use Datastream 7i to drive asset performance and ensure the delivery of projected financial results. With the Calibration software module, life science companies can free up resources that would normally have been lost to tracking and maintaining equipment and instrument calibration. Contact us to learn more about calibration software and the Asset Performance Management solutions.
Calibration Software: Part of a Comprehensive Solution
Customers rely on Datastream products and services to drive down costs and improve their bottom line through effective Asset Performance Management. The Calibration software module is part of a comprehensive asset management solution available through Datastream products. For those involved in life science, pharmaceutical, and a number of other regulated industries, Datastream asset management solutions provide invaluable tools.
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