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Bringing a new drug to market can take a life sciences company 12 or more years, cost millions of dollars, and generate thousands of pages of documentation. ECM systems are critical to managing this documentation, which can include FDA submissions for new drugs, clinical trial information, and Standard Operating Procedures (SOPs). With an effectively deployed ECM system, life sciences companies reduce the cost and complexity of regulatory submissions and enable compliance, ultimately bringing new products to market faster and more efficiently.

Logical errors such as programmatic, user, and operational errors that affect one, several, or thousands of objects cause over 80% of ECM information loss and corruption.* When records and their audit trails are lost or corrupted due to a logical error, the results can be devastating. If just one small piece of an FDA submission is missing, it can be rejected, causing delays in the 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 bringing a drug to market.**

testtubes.jpgFurthermore, the inability to produce information in response to myriad regulations specifying the preservation of information such as FDA CFR Part 11 and industry Good Practices (GxP) requirements can be disastrous. Repercussions can include clinical studies being placed on hold, significant fines, and withdrawn approval of New Drug Applications. CYA has helped over half of the 50 largest life sciences companies safeguard and optimize their ECM investments for close to a decade by:

  • Facilitating compliance with initiatives requiring the capture, preservation and production of native electronic content and audit trails.
  • Ensuring business continuity and 24x7 access to accurate ECM information.
  • Enabling fast, hot granular recovery of authentic ECM objects in response to
    logical errors.
  • Mitigating the need to bring users offline for synchronized backups. 
  • Minimizing recovery times and data loss in the event of disaster via seamless integration with traditional backup and recovery solutions including EMC NetWorker, IBM Tivoli Storage Manager, and Symantec Veritas NetBackup.

Learn about CYA products
Read about FDA Validation Services
Read Boehringer-Ingelheim case study
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*Strategic Research Inc. & AIIM International
**Tufts Center for the Study of Drug Development