Validation Protocol

• Comprehensive pre-written test guidelines and checklists for system validation
  
  
• Includes installation qualification and operational qualification procedures and forms, comes in a binder with a CD version
  
  
• Documents provided in Microsoft Word format for easy customization

What is a Validation Protocol?

A validation protocol comprises all documents outlining tests and instructions to be executed for a process, equipment validation or analytical method validation etc. These are referenced in your validation master plan.

A validation plan (VMP) is an outline of the entire validation project, including the timeline, responsibilities and approach. It can be focused on qualifying a new piece of equipment or environment, or validation a product or process. It will include any software /network validation.

A VMP is an internal document created to systemize the validation for your organization, however. The need for a VMP will be decided by the size, frequency and complexity of your validation projects.

By contrast, you will always need validation protocols. Veriteq's Validation Protocol is designed to verify the performance of the VL-1000, VL-1000-VLT, and VL-2000 temperature and relative humidity data loggers and to assist in validating the Veriteq vLog software for use within your facility.

This validation processes provide assurance that the system has a high level of integrity and the data is both accurate and reliable.

The package includes customizable installation qualification (IQ) and operational qualification (OQ) procedures, forms and templates to enable validation personnel to record all details needed to demonstrate that the system is working properly.

A good source for information can be found in the ISPE Base Guideline Volume 5 Commissioning and Qualification. The most current version can be purchased through the ISPE.

Contact Veriteq for more information on our protocols.