Validation Planning

During the Validation Planning phase, the following activities are performed:

Hardware Risk Assessment
Software Risk Assessment
Preparation of the Validation Matrix
Development of a Detailed Validation Schedule
Preparation of the Validation Master Plan (VMP)

Risk Assessment in Computerized Systems Validation (CSV) involves identifying potential risks associated with the operation of the Computerized System, assessing their criticality to Product Quality/Safety, and defining measures to mitigate critical risks.

The Risk Assessment is documented in a table, with each row describing an individual risk. As in classical Risk Analysis, potential risks are examined systematically, following the System Diagram, Software Structure, Process Flow, Interface Elements/Perimeter, or along any convenient framework/object sequence. Additionally, the risk list is supplemented with well-known risks, risks described in documentation, risks identified in past projects, and risks discovered during brainstorming sessions.

In accordance with GMP requirements, the "Four-Eyes" Principle should be applied, meaning that at least two specialists must work on the Risk Assessment – either simultaneously or sequentially.

The Validation Matrix is a tabular representation of System Components and Validation Activities, where each component is linked to the necessary Validation Tasks.

The column headers in the matrix use abbreviations established in the project (Project Master File) to represent validation activities. To populate the matrix in relation to Validation Sub-Phases broken down according to the V-Model, the information from the final column of the Risk Assessment Table is used. Hardware and Software can be divided into two separate matrices if necessary.

If a validation activity applies to multiple Software Layers (e.g., Functional Testing), the corresponding cells may be merged.

Based on the Validation Matrix, the Validation Schedule is created.

Individual validation activities for all components are transferred from the Validation Matrix into a table or Gantt Chart for the project. Each activity is assessed for labor/time requirements. With consideration of the Project Schedule (Project Master File) and interdependencies of validation activities, work dates are assigned. The final schedule must be approved by all members of the Validation Team and the System Developer/Supplier.

The Validation Master Plan (VMP) is the primary document that defines the validation strategy, documentation formats, validated components, validation team members, and validation activity schedule.

A typical Validation Master Plan includes the following sections:

Introduction
Structure and Organization of Validation Activities
Validation Strategy
Additional Activities per GMP Requirements (e.g. Calibration)
Validation Documentation Format
System Description
Validation Activities Planning
- Validation Matrix
- Validation Schedule
Glossary
Appendices

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.