Vector Validation Group Services

Vector maintains an engineering design group dedicated to providing detailed validation test plan documentation for our pharmaceutical customers.

This group creates Installation Qualification and Operational Qualification document test plans to assist our customers in providing the documentation necessary to maintain Vector pharmaceutical process equipment in a validated state.

This documentation has proven to be a significant cost savings to our customers.

This test plan set supplements Vector’s Operation and Maintenance Manuals that accompany all our new equipment.

A typical validation documentation set would include:

Standard Documentation:

Validation Protocol	A document that describes the validation scope and methods to be used during the design and validation of the equipment.
Validation Team	Documents the Vector validation team members and provides spaces to identify the customer validation team member’s names, signatures and initials for the life of the machine.
Protocol Approval  Document	Documents approval of the validation documentation prior to executing the documents on-site.
Discrepancy Reporting Form	Provides a standard form for recording any deviations found during testing.
Validation Sign-Off	Documents the final completed protocol
A Listing of Materials In Product Contact	List of materials in product contact and their composition.

Installation Qualification:

Installation Qualification Test Plan	Documents the environment that the machine is installed in.  Verification of utilities, record of serial numbers, documents current manual and drawing status and location.
Software Confirmation Test Plan	Verifies all software modules and operating system configurations at time of installation.

Operational Qualification:

Security Test Plan	Tests the security system and/or configuration of the control system.
Input Output Test Plan	Tests the machine inputs and outputs to the controlling devices.
Manual Mode Test Plan	Tests the operation of the typical manual operation of the system.
Automatic Mode Test Plan	Tests the operation of the typical automatic functions of the system.
PID Test Plan	Tests the performance of the dynamic control loops in the system.
Alarm Test Plan	Tests the system alarms and responses.