ZyLAB Announces Low-Cost, FDA-Compliant Content-Management Solution

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ZyLAB, developer of content management and compliance solutions for paper intensive organizations, announced the availability of its new FDA-compliant content-management solution for the pharmaceutical and biotechnology industries. In most cases, not only will the ZyLAB FDA-compliant solution cost up to a third less than other comparable systems, but it will take a fraction of the time to deploy.

ZyLAB has bundled the technology required by leading firms into a standard, scaleable ZyIMAGE-based system that contains the most advanced tooling available, on a scale that is flexible for specific organizational needs. This mix of scalability and functionality is proving to be a successful strategy for ZyLAB in its continued penetration of the pharmaceutical and biotechnology records-management market, particularly in terms of providing enhanced value for money. Most importantly, ZyLAB's ZyIMAGE pharmaceutical and biotechnology solution is completely aligned with rigid FDA guidelines for records management.

The ZyIMAGE solution is used for digital capture and archiving of lifecycle GMP records, as well as all paper records requiring back up, such as validation protocols, validation reports and batch records. This ZyIMAGE solution also controls document review and access through a specialized interface or web browser, while maintaining a full audit trail of all actions performed. Many of ZyLAB's clients in this market are able to adapt and implement the ZyIMAGE solution in numerous departments across the entire firm, such as R&D, engineering, manufacturing, quality control, distribution, and global operations.

Of course, any ZyIMAGE solution includes standard core ZyIMAGE features such as fuzzy search, hit navigation and highlighting, no additional plug-ins, tools for publishing archives to CD or DVD, and more. These capabilities have always formed one of the most attractive tool suites for organizations that are required to adhere to a variety of regulations and rigid business practices, as well as remaining vigilant against fraud. In fact, most Federal and private-sector regulators rely on ZyLAB software to help conduct their audits and investigations.

In accordance with FDA guidelines, the audit trails utilized by this ZyIMAGE solution for relevant actions are fully compliant with 21 CFR Part 11. Full documentation has been prepared and approved for the ZyIMAGE solution.

14.06.2005, ZyLAB




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