What are the Deviations?

Deviations and corrective and preventive measures (CAPA) are among the most important, practical and key concepts of quality assurance in the pharmaceutical industry. Deviation refers to the difference between expected or normal values and observed values for a product or process. These deviations can occur during testing, sampling, manufacturing or acceptance of raw materials and finished products. The process of dealing with deviations includes identifying their criticality, performing root cause analysis and proposing corrective and preventive measures. FDA guidelines emphasize documenting procedures for stopping operations, recording nonconformances, investigating discrepancies, and implementing corrective actions. The general concept of deviations is any difference between instructions, processes and rules and conditions defined by high-level documents in production and non-production space. The quality assurance department is required to collect these events from the reporters and detect possible deviations during the implementation of a predefined process, and if the deviation is significant, corrective and preventive measures must be taken by implementing the CAPA process to achieve follow up on results and effectiveness.

What is Gito deviations software module and what is its functions?
This module is part of the GITO ECOSYSTEM software collection and is a comprehensive application for creating and tracking all deviations and CAPA in the processes of the pharmaceutical industry and medical equipment in a completely paperless and mechanized way. With the help of this module and implemented tools, users can easily register deviations without the need for traditional forms, and the software follows the process according to the instructions. According to their defined roles and organizational positions, users can perform the required operations in different stages according to the job description. All processes related to deviations and CAPA in seven stages include registration of deviations, manager's approval, quality assurance expert review, quality assurance manager's approval, CAPA registration, CAPA reports, summarizing and closing the case. The software intelligently monitors all functions, data entry and user activities in all stages to prevent possible human errors. The software supervises compliance with the hierarchy in performing required operations and signatures, as well as displaying and making data available based on the user's access and needs, and preventing the entry of inappropriate or wrong information, as well as checking for possible discrepancies.

GITO Deviation Recording and Tracking Process

All processes for deviation and CAPA registration and follow-up are fully paperless and automated in 7 steps.

Registration

Users can submit and track deviations online

Manager's Approval

Manager approval of the registering individual

QA Expert Review

Initial review by the quality assurance specialist

QA Manager's Approval

QA manager approval and deviation type determination

CAPA Registration

CAPA submission by the QA manager enabled.

CAPA Reports

Unlimited action definition and CAPA report entry.

Closing the Case

Closing deviation and CAPA cases with print