Deviations and Events

Providing a secure and reliable system for tracking and reporting deviation and event records in accordance with current Good Clinical/Laboratory/Manufacturing/Pharmaceutical Practice. Generica QMS Deviations and Events module allows its users to analyze previous problems and identify opportunities for quality improvement, all effectively managed on a global scale to ensure company-wide regulatory compliance.

 

Handling deviations and events properly is a key factor for any Life Science comany's successful quality management. Deviations, events, incidents, and some other terms used by different companies encompass a variety of issues to be taken care of, that may span the entire operational process, for example, failures in production, packaging, labeling, warehousing, shipment, information systems, etc.

 

Generica Deviations and Events module facilitates the problems capture and resolving process by providing on the one hand a pre-packed solution based on best practices to be smoothly deployed, where on the other hand allows for each comapny to easily configure its own specific processes - according to the organization's procedures and requirememnts. This module supports a hierarchial structure of record types, where each deviation may result in required investigations, CAPAs, reporting etc, and can be linked to other processes, such as quality risks.

 

 

Features

To achieve full coverage of Deviations and Events management the following functionality is available:

  • End-to-end process flow – from initiation to closing

  • Electronic signature 21 CFR part 11

  • CAPAs and Action Items

  • Alerts and reminders

  • Reporting tools

  • Full search, statistic and trends

  • Management dashboards & graphs

  • Powerful and flexible permissions for users and grops

  • Full audit trail and history

 

KCS offers end-to-end Quality Management and GRC Management solutions for highly regulated industries, such as life science, finance, and insurance. Through its flagship solution platform – Generica – the company allows its users to manage and improve their internal processes, while ensuring compliance with relevant requirements and standards of both local and global authorities.