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:
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: