K2C Validation Management Solutions

Validation in a pharmaceutical company is one of the bigger concern and effort, requiring a lot of time and resources for writing documentation, managing issues and approval process, applying change control and other procedures, and last but not least archiving or finding documents!

K2C Validation Management solution allows to assess any Information System or Equipment and maintain a real-time Inventory with the full visibility of validation status, validation documentation, issues and criticalities.

The solution provides an unique opportunity to significantly reduce the compliance cost and required effort by a series of tools facilitating the validation process and making your job faster, easier and more consistent with applicable standards and best practices.

Our solution helps you in any step of validation lifecycle and includes the following features:

Definition of Validation Policies and SOPs
Management of validation templates
Management of System Inventory
Management of Approval Workflows
Risk-based Criticality Assessment Tools
Automated or assisted planning of validation activities
Possibility of integration with other K2C applications (SOP, Training, Change Control, Deviations and CAPA etc.)