21 CFR Part 11 Compliance.com

Digital Lab. Notebook

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The smooth, efficient and uninterrupted flow of business information is the lifeblood of a successful company.  It should come as no surprise that electronic and digital laboratory notebook systems are a hot topic today. Because of the huge increase in the amount of mission-critical data—as well as growing concerns and new regulations regarding data availability—disaster recovery and business continuance are leading information technology and compliance managers  to revisit their current data aggregation and data recording procedures. As a result, they are looking at adopting procedures
that allow digitally recording all study information.

Centralized location of all study related information, authenticity of associated data files and attachments, and the elimination of manually intensive data redundancy procedures are just a few of the benefits of digitally recording all study based information.  In addition, a digital laboratory notebook allows superior collaboration and work sharing, and is ideally suited for electronic archiving, backup and restore.

IA-DLN enables organizations to:

  • Efficient study management through customizable notebook. IA-DLN's unique web based interface is intuitive and allows each notebook to be customized based on specific requirements for a given study.
  • Improved Sharing and Collaboration
    IA-DLN aggregates all study related information -- study and protocol setup info.; bioanalytical methods; sponsor communication document attachments; instrument raw data; laboratory observation and notes, .. Only authorized personal based on task based security are allowed access for work sharing and collaboration.  Thus contributing to creation of the knowledge base of your enterprise.
  • Accelerating data review processes
    As technology speeds the pace of business, companies can no longer afford the delays associated with routing paper documents through critical processing and approval stages. IA-DLN based information can be accessed by a point and click for review and reporting tasks thereby improving the overall productivity
  • Improved electronic archiving processes
    With all study related information centrally stored in IA-DLN's secure data repository, it's quite efficient to archive an entire study complete with index and table of contents. 
  • Compliance requirements – With 21 CFR Part 11, GLP (Part 58), ISO, HIPAA, and newly emerging regulations from FDA and other enforcement agencies, every company must comply with a mountain of new requirements in addition to older regulations surrounding the creation and manufacture of industry-specific products and services.
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