TrackWise Software in Pharma l TrackWise in Pharmaceutical industry Interview question and answers

This video provides an in-depth exploration of TrackWise software, a widely used Quality Management System (QMS) in the pharmaceutical industry. Presented in an interview question-and-answer format, the content systematically addresses the functionalities, advantages, regulatory implications, and integration capabilities of TrackWise. The primary purpose is to educate viewers on how TrackWise supports quality management and regulatory compliance within the highly regulated pharmaceutical sector, offering insights into its practical applications and benefits over traditional paper-based systems.

The discussion begins by defining TrackWise as a critical software for managing various quality-related processes, including deviations, Corrective and Preventive Actions (CAPAs), change controls, market complaints, audits, and supplier quality management. It also highlights its utility in broader areas such as regulatory compliance, risk management, document management, and training management. A significant portion of the video is dedicated to outlining the ten key advantages of TrackWise, such as centralized data management, improved accessibility, real-time updates, enhanced security, efficient document retrieval, automated workflows, integration with other systems, comprehensive reporting, trending capabilities, and robust regulatory compliance support.

The video further delves into how TrackWise specifically aids in regulatory adherence, emphasizing its role in facilitating documentation, reporting, and generating essential audit trails required by bodies like the FDA. It details how the software manages deviations in manufacturing through configurable workflows and automated notifications, ensuring prompt investigation and resolution. A crucial theme is data integrity and compliance with regulations like 21 CFR Part 11, which TrackWise addresses through features like electronic signatures, comprehensive audit trails, and stringent data security measures. The discussion concludes by covering practical aspects such as device accessibility, security protocols, the significance of electronic signatures, inter-departmental collaboration, workflow customization, common industry uses, and its ability to integrate with other enterprise systems like ERP, LIMS, and EDMS.

Key Takeaways:

• Comprehensive Quality Management: TrackWise serves as a centralized platform for managing a wide array of quality events and processes within the pharmaceutical industry, including deviations, CAPAs, change controls, market complaints, audits, and supplier quality management.
• Enhanced Regulatory Compliance: The software is instrumental in helping pharmaceutical companies meet stringent regulatory requirements from bodies like the FDA by providing robust documentation, reporting, and audit trail capabilities.
• Superior to Paper-Based Systems: TrackWise offers significant advantages over traditional paper-based QMS, including centralized data management, real-time updates, improved accessibility, enhanced security, and efficient document retrieval.
• Automated Workflows and Efficiency: It streamlines quality processes through automated workflows, reducing manual effort, minimizing errors, and ensuring timely execution of quality-related tasks.
• Robust Data Integrity: TrackWise ensures data integrity and compliance with regulations such as 21 CFR Part 11 through features like electronic signatures, comprehensive audit trails that track all data entries, and stringent security measures to prevent unauthorized changes.
• Increased Transparency and Accountability: The system maintains detailed audit trails and documentation, providing transparency and traceability for all quality-related activities, findings, and actions, thereby enhancing accountability across the organization.
• Ubiquitous Accessibility: As a web-based application, TrackWise can be accessed from any device with an internet connection and appropriate permissions, facilitating remote work and real-time collaboration.
• Advanced Security Measures: The software incorporates robust security features, including role-based access control, encryption, and authentication mechanisms, to safeguard sensitive quality data and ensure compliance with data privacy regulations.
• Significance of Electronic Signatures: Electronic signatures within TrackWise are crucial for securely authorizing and authenticating data entries, maintaining the integrity and authenticity of electronic records in a regulated environment.
• Facilitates Inter-Departmental Collaboration: TrackWise enables real-time data sharing across different departments within a pharmaceutical company, fostering improved communication and collaboration through a centralized platform.
• Customizable Workflows: The software offers highly customizable workflows, forms, and reports, allowing organizations to adapt the system to their specific operational needs and regulatory requirements.
• Integration Capabilities: TrackWise supports seamless integration with other critical enterprise systems such as Enterprise Resource Planning (ERP) systems (e.g., SAP), Laboratory Information Management Systems (LIMS), and Electronic Document Management Systems (EDMS), enabling efficient data exchange and workflow integration.
• Current Versions and Evolution: The software is continuously updated, with versions like TrackWise 8.x, 9.x, and the latest TrackWise 10.x (released October 2023) offering enhanced functionalities and user experiences, with selection depending on organizational needs and infrastructure.

Tools/Resources Mentioned:

• TrackWise: Quality Management System software (versions 8.x, 9.x, 10.x)
• ERP (Enterprise Resource Planning) systems: General mention, with SAP given as an example.
• LIMS (Laboratory Information Management Systems)
• EDMS (Electronic Document Management Systems)

Key Concepts:

• QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• CAPA (Corrective and Preventive Actions): Actions taken to eliminate the causes of existing nonconformities or other undesirable situations and to prevent their recurrence.
• Deviations: Departures from approved instructions or established standards.
• Change Control: A formal process used to ensure that changes to products, processes, or systems are introduced in a controlled and coordinated manner.
• Regulatory Compliance: Adherence to laws, regulations, guidelines, and specifications relevant to the pharmaceutical industry (e.g., FDA, 21 CFR Part 11).
• FDA (Food and Drug Administration): The U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
• 21 CFR Part 11: Regulations issued by the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• Data Integrity: The assurance that data is accurate, consistent, and complete throughout its lifecycle, crucial for regulatory compliance.
• Electronic Signatures: A secure method for authorizing and authenticating data entries in electronic records, legally equivalent to handwritten signatures under 21 CFR Part 11.
• Audit Trails: A chronological record of system activities, including who accessed what data, when, and what changes were made, essential for traceability and accountability.
• Role-Based Access Control (RBAC): A security mechanism that restricts system access to authorized users based on their role within the organization.
• Encryption: The process of converting information or data into a code to prevent unauthorized access.
• Authentication: The process of verifying the identity of a user or system.