CP3 Blister Pack Machine Validation

Industry

Pharmaceutical

Business Issue

The client purchased a new CP3 Blister Pack Machine to increase the ability to package pharmaceutical products for Clinical Trials and was faced with needing to perform Computer System Validation (CSV) activities in order to use the machine.

Project Summary

The project involved providing a number of CSV deliverables for the client.  The Cornerstone Controls project group coordinated their efforts with the client and the OEM vendor.

Scope Responsibility

Cornerstone Controls was responsible for the following areas:

  • Review and provide input as needed on the Validation Plan.
  • Review and provide input as needed on the Functional Requirements.
  • Review and provide input as needed on the Vendor Evaluation.
  • Review the System Overview document for the EAS machine and evaluate its’ usefulness for CP3 as a starting document.  Author the document for CP3.
  • Review the System Configuration document for the EAS machine and evaluate its’ usefulness for CP3 as a starting document.  Author the document for CP3.
  • Review the Functional Design document for the EAS machine and evaluate its’ usefulness for CP3 as a starting document.  Author the document for CP3.
  • Review the EAS machine Programming Standards document to ensure that all equipment (SLC plus PanelView) is covered that will require a SCR.  Submit for approval.
  • Review the EAS machine Source Code Review document to ensure that all equipment (SLC plus PanelView) is covered.  Submit for approval.
  • Execute informal SCRs at 25% intervals.
  • Execute the formal SCR at the end of development.
  • Attend the Pre-FAT.
  • Attend the FAT (informal).
  • Furnish the Test Plan.
  • Furnish the IQ (Control System Portion) document based on the IQ document for the EAS machine
  • Be present during IQ testing and assist with any required documentation updates.
  • Furnish the OQ (High Level - Control System Portion) document based on the OQ document for the EAS machine.
  • Furnish the OQ (System Level Tests Portion) document based on the System Level tests for the EAS machine.
  • Be present during OQ testing and assist with any required documentation updates.
  • Furnish the Test Summary document.  With guidance from the client, Cornerstone will select templates from a previous project to use as a template for the report and furnish it for the CP3 machine. 
  • Furnish the Traceability Matrix.  With guidance from the client, Cornerstone will select templates from a previous project to use as a template for the document and furnish it for the CP3 machine
  • Write the Validation Report.  With guidance from the client, Cornerstone will select templates from A Previous Project to use as a template for the report and furnish it for the CP3 machine
  • A document will be used for this deliverable, not a procedure. With guidance from the client, Cornerstone will select templates from a previous project to use for the CP3 machine and furnish the document.
  • Furnish the Pre-Implementation Change Control document. With guidance from the client, Cornerstone will select templates from a previous project to use as a template for the report and furnish it for the CP3 machine.
  • Track any Pre-Implementation code changes
  • Provide project management of the Cornerstone work.
  • Develop and maintain the project schedule of Cornerstone efforts, as well as the client’s efforts to the major milestones.
  • Conduct project review meetings as needed.
  • Provide project status reports.

Results

All validation deliverables completed and approved; system is ready for use in Clinical Trials packaging.