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Computer System Validation Procedures and Templates Suite for Medical Devices

30 Day Money Back GuaranteeComputer System Validation Procedures and Templates Suite for Medical Devices
Item# MDSuite
$999.00
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Return on Investment

Kymanox estimates that it would take a qualified contractor 360 hours 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.

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.

Not a medical device company?  See our Pharmaceutical & Biotechnology version.

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.

These procedures and templates provide a detailed outline of how to validate a computer system in a regulated environment. 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 package includes:

Microsoft Word (.doc)  Microsoft Excel (.xls)  Adobe PDF (.pdf)

Documents included in the suite are as follows:

  • Overall Validation Process (22 pages)
  • Validation Project Plan Procedure & Template (15 & 10 pages)
  • User Requirements Specification Procedure & Template (11 & 9 pages)
  • Software Requirements Specification Procedure & Template (20 & 20 pages)
  • Part 11 Assessment Procedure (12 pages)
  • Cyber-Security Guidelines (8 pages)
  • Assessing Level of Concern Procedure (22 pages)
  • Risk Assessment Procedure & Template (10 pages & Spreadsheet)
  • Architecture Design Chart Procedure (8 pages)
  • Software Design Specification Procedure & Template (18 & 10 pages)
  • Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
  • Design Review Procedure & Template (7 & 4 pages)
  • Change Control Procedure & Template (16 & 3 pages)
  • Commissioning Protocol Procedure (7 pages)
  • Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
  • Installation Qualification Template (2 pages)
  • Operational Qualification Template (2 pages)
  • Performance Qualification Template (2 pages)
  • Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (6 pages)
  • Exception Reporting Procedure & Template (16 & 2 pages)
  • Validation Monitoring Procedure & Template (11 & 4 pages)


With this KymaSTORE purchase, you will also receive a 60 minute conference call with a Kymanox Subject Matter Expert and complimentary package updates for 6 months from the original date of purchase.

Related Kymanox Services:


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