Computer Systems Validation, Focus Environmental, Inc., Knoxville, TN, Validation Plans, Summary Reports, User Requirement Specification, Functional Detailed Descriptions, Automated Processes, Network/IT Infrastructure, Software Imbedded Devices Focus Environmental, Inc. - Computer Systems Validation
OUR SERVICES
Engineering Solutions to Environmental Problems
www.focusenv.com
Focus CVS > Computer Systems Validation 
    Printable Page     Email Email This Page     Save To Favorites Save To Favorites

Computer Systems Validation


    Email Email This Page  
    Save To Favorites Save To Favorites
  

4x3-Computer-Systems-Validation

larger image

The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. Focus personnel have experience with computer systems validation activities and provide services for a full range of validation deliverables, from Validation Plans through Validation Summary Reports.

Current Events
Hospitals need to be aware of new regulations that were passed by the FDA on February 14, 2011 regarding Medical Device Data Systems (MDDS).  The first compliance date has already passed and the next compliance date is April 18, 2012.  To learn more about the MDDS rule and now it impacts hospitals, go to www.mddsrule.com.

Services

Focus delivers services and tools to help clients integrate good software-based engineering practices into their product-development methodologies for the purpose of FDA regulatory compliance. These services include:

  • User Requirement Specification
  • Functional Detailed Descriptions
  • Automated Processes
  • Network/IT Infrastructure
  • Software Imbedded Devices
  • Traceability Analysis
  • CSV Master Planning
  • Configuration/Change Management
  • Software Validation and Software Development Life Cycle
  • Computerized Systems
  • Part 11: E-records and E-signatures

Focus Compliance & Validation Services