SOURCE: CYA Technologies

August 05, 2008 08:00 ET

Increased Awareness of Partial Information Loss & Proliferation of Regulatory Requirements Drives Demand for Granular Recovery of ECM System Information Within Pharmaceutical Industry

Over 60 Pharmaceutical Companies Including Half of 50 Largest Rely on Solutions From CYA Technologies

SHELTON, CT--(Marketwire - August 5, 2008) - Pharmaceutical companies may have disaster recovery plans and backup systems in place, but many are still leaving critical data -- and their companies -- at risk. Over 60 pharmaceutical companies, including half of the 50 largest,* such as GlaxoSmithKline and Abbott Laboratories, protect themselves against incomplete eSubmissions and non-compliance with CYA SmartRecovery from CYA Technologies, the leader in solutions protecting enterprise content management (ECM) investments.

The majority of ECM information loss is caused by partial information loss incidents** -- common occurrences such as programmatic, operational, and logical errors, malfeasance, and metadata corruption that cause the loss of one, several, or thousands of pieces of information within eSubmissions or other vital documents. If just one small piece of an eSubmission is missing or corrupted, it can be rejected by the FDA, causing delays in a new drug's time-to-market. This can mean a loss of millions of dollars for a pharmaceutical company, where potential drug sales of well over $1 million are lost for every extra day spent in bringing a drug to market, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), Tufts Center for the Study of Drug Development, and others.

Furthermore, the inability to produce information in response to myriad industry and government regulations requiring the preservation of information such as FDA CFR Part 11 and the Federal Rules of Civil Procedure eDiscovery amendment, which makes electronically stored information discoverable during legal proceedings, can be disastrous. Repercussions of non-compliance can include clinical studies being placed on hold, significant fines, withdrawn approval of Initial New Drug Applications, negative brand exposure, and in extreme cases, criminal prosecution.

According to CYA Technologies, the proliferation of regulatory requirements, combined with an increased awareness of partial information loss incidents in the industry, is driving demand among pharmaceutical and life sciences companies for ECM granular recovery solutions. CYA SmartRecovery, an application-aware, granular recovery solution providing hot, synchronous backups of ECM information, protects the ECM assets of more than 60 pharmaceutical companies, including AstraZeneca, Achillion Pharmaceuticals, Apotex, Boehringer-Ingelheim, Campbell Alliance, i3 Global, PAR Pharmaceutical, and United Therapeutics.

"Achillion has invested extensive resources into its ECM system in order to bring products to market faster and more efficiently. We take any threat to the information stored in it very seriously because we realize that if the data is rendered inaccessible, it degrades our investment and can cost us millions of dollars in lost revenue," said Alex Reznitsky, Systems Analyst, Achillion Pharmaceuticals. "CYA SmartRecovery gives us confidence that we can quickly and easily recover information without negatively impacting productivity, maximizing the odds that we'll get our drugs to market on time and at the lowest possible cost."

"Most life sciences companies have come to realize that their traditional disaster recovery solutions are not enough to protect their critical ECM information. They must be able to recover authentic documents and metadata such as audit trails at a granular level without any downtime to mitigate compliance risks and avoid costly delays in bringing drugs to market," said Wayne Crandall, president and CEO of CYA Technologies. "The companies that haven't yet protected their ECM assets with CYA SmartRecovery are compromising their fiscal health because it's only a matter of time before they experience the revenue-draining impact of partial information loss."

CYA also offers a five day Rapid Deployment Program (http://www.cya.com/en/Solutions/LifeSciences/FDAValidation/tabid/186/Default.aspx) with FDA validation for CYA SmartRecovery that helps pharmaceutical and life sciences companies comply with FDA 21 CFR Part 11 regulations that mandate the validation of computer systems used in FDA-regulated Good Practice (GxP) activities and regulatory filings.

For more information about CYA, visit www.cya.com or call +1.203.513.3111 ext. 501.

About CYA Technologies

CYA Technologies provides the only end-to-end portfolio of solutions that optimize enterprise content management (ECM) investments, facilitate compliance, and insure companies against the risks of ECM information loss. CYA solutions support ECM systems including EMC Documentum, IBM FileNet P8, and OpenText Livelink, and protect over one thousand repositories at more than 250 global organizations including DuPont, SwissRe, Standard & Poor's, Boehringer-Ingelheim, Gruenthal, British Petroleum and the U.S. Army. The company is privately funded and headquartered in Shelton, Connecticut with regional offices through the United States and Europe.

*50 largest per the Pharm Exec 50 published May, 2008

**According to AIIM International and Strategic Research Inc.

Contact Information

  • Contact:
    Lauren LaFronz
    Director of Marketing
    CYA Technologies
    203.513.3111 x 531
    Email Contact