Project Identification

The first stage of any computerized system implementation project, including computer system validation, should be project identification (initialization). At this stage, no development or validation work is carried out, but rather an inventory of available initial information is conducted, the project team is established, and "starting points" are recorded. From this moment on, Change Control is applied.

The outcome of project identification is the Project Master File, which contains:

A detailed explanatory note with information about the project
Appendices – available initial documentation, such as: customer requirements, supplier specifications, applicable standards/SOPs, etc.

The Project Master File should establish/define:

The project’s objective
Standards/Quality Management Systems (QMS)
Main hardware
Main software
Project team
Project schedule
Project documentation

The Master File should clearly define the project's goals, addressing the following questions:

What system will be implemented?
What will it be used for?
What are the key specifications of the system?
Who/which departments will use it?
Who will be the system supplier (or how will the supplier be selected)?
What company resources will be engaged?
When is the system planned for implementation?

At this stage, the project team must also be formed, with members assigned specific roles/functions/responsibilities, including:

Project Manager/Moderator
QA Representative
IT/Instrumentation and Automation Representative
Supplier Representative (!)
Subject Matter Expert (SME)
Process Owner
System Owner

The above roles may be combined, but the project team must include more than one member (GMP requirement). The project team participants should undergo joint training.

To ensure the successful launch of the project, the necessary documentation must be prepared, and documentation management measures must be implemented, specifically:

Conduct an inventory of available documentation
Request/develop missing documentation
Record titles, authors, dates/version numbers, etc. (in accordance with GMP)
Initiate the application of Change Control
Develop and approve the format/templates for project and validation documentation
Attach available documents to the Master File

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.