Deviation Management

Additional features

1. Digital Deviation Form

Replaces paper forms with a digital form that is filled out step-by-step and offers mandatory fields and drop-down functions for data entry, simplifying data capture and minimizing errors.

2. Workflow System for Process Steps

Controls the deviation process through predefined steps (initiation, root cause analysis, risk assessment, etc.) and automatically sends tasks and notifications to responsible processors, ensuring a structured and efficient process flow.

3. Automated Task Distribution

The workflow system automatically distributes tasks to the responsible processors, based on configuration or manual selection, speeding up process initiation and responsibility assignment.

4. Representation Rule in Task Routing

The system includes a rule for representation to ensure seamless processing and task forwarding even in the absence of employees, securing process continuity.

5. PDF/A Conversion of Digital Forms

The digital forms are converted in parallel into PDF/A documents, allowing employees without direct workflow access and external parties to view the deviation documentation.

6. Audit Trail Function

Integrates a comprehensive audit trail that automatically logs every action in the system, guaranteeing complete traceability and supporting compliance requirements.

7. Definition of the Deviation Control Process

The software supports the entire deviation control process, from the identification and assessment of deviations to the decision on further action and the implementation of measures, ensuring all relevant aspects of deviation management are covered.

8. Application Area for Various Departments

The software is relevant for various areas including production, quality control, quality assurance, QM representatives, Qualified Persons (QP), galenics, and audit trail tracking, demonstrating the broad applicability of the software.

9. Mandatory Input Fields

Blue-highlighted fields in the digital forms indicate mandatory fields to ensure that all necessary information is captured, improving data quality and completeness.

10. Predefined Value Sets and Drop-Down Functions

The system offers predefined value sets and drop-down functions in the forms to facilitate data entry and increase data consistency, improving user-friendliness and efficiency.

11. Deviation Recording by Every Employee

Any employee can record a deviation in the system, promoting broad participation in quality management and early detection of problems.

12. Live Demo/Webcast Option

Interested parties have the option to receive a live demonstration of the software via a webcast, allowing for a direct showcase of software features and benefits.