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Kevin C. Brown, PMP
Subject Matter Expert
Kymanox

Computer System Validation for Medical Devices Toolkit

Comprehensive toolkit with procedures, protocols, and forms for Computer System Validation for the medical device industry
Product Description

This package features 34 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within a Medical Device organization. The procedures and templates apply to computerized systems that impact GXP operations, product quality and safety at a Medical Device organization. Software which must meet global medical device regulations, including those that impact software developed internally or purchased "off-the-shelf" (OTS), can be validated using the procedures and templates provided in this package. A roadmap for which documents must be included as well as sections and topics that need to be included in each document are covered in detail.

This product addresses the folllowing key concepts:

  • Overall Validation process
  • User Requirements, Software Requirements, Architechure Design Chart
  • Installation Qualification, Operational Qualification, and Performance Qualification
  • Exception Reporting
  • Validation Monitoring
Includes:  
Purchase Price   $999
Overall Validation Process Word yes
User Requirement Specification Template Word yes
Software Requirement Specification Template Word yes
Part 11 Assessment Procedure Word yes
Risk Assessment Procedure Word yes
Cyber Security Guidelines Word yes
Assessing Level of Concern Procedure Word yes
Architecture Design Chart Procedure Word yes
Software Design Specification Template Word yes
Traceability Analysis Template Word yes
Design Review Template Word yes
Change Control Procedure Template Word yes
IQ/OQ/PQ Procedure Template Word yes
Exception Reporting Template Word yes
Validation Monitoring Template Word yes
Optional 60 Minute Consultation with Subject Matter Expert (SME) Consultation yes
Purchase  

 

Return on Your Investment

Kymanox estimates that it would take a qualified contractor 360 hours (310+50) to complete the work included in this package.

This estimate is based on our extensive experience creating these and other templates and procedures, as well as averages that we have observed across the industry.

Please use the calculator at right if you would like to see how your own calculations affect the dollars and time saved by purchasing our package. You can replace the numbers for "Effort Hours to Complete" as well as "Labor Rate" in order to see differences.

Labor Rate is defined as the overall cost of one employee per hour (including pay rate and benefits), or the overall cost of one qualified contractor per hour. Kymanox estimates this at $100/hour for a qualified contractor.

Available Hours Per Day refers to the number of hours a single resource has to work on the project per day.  8 hours assumes that the resource is fully dedicated to the project.

   
   
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