QuickFlow LIMS
Laboratory Information
Management System
Quickflow eSheet
Calculation Sheet
Quickflow QMS
Quality Management
System
Quickflow DMS
Document Management
System
Quickflow - Quality Management System
Efficiently manages and streamlines pharmaceutical quality processes, including change controls, deviations, CAPA, market complaints, and OOS, enhancing precision and efficiency while ensuring compliance and real-time visibility.
- Overview
- Challenges
- Features
- Key Benefits
Overview
Webosphere eQMS, an acronym for electronic Quality Management System, stands as a cutting-edge digital solution designed to empower organizations in efficiently overseeing their quality processes and meeting compliance standards. Functioning as a sophisticated software platform, it facilitates the streamlined management of diverse quality-related activities, including Change Control, Deviations, Corrective and Preventive Actions (CAPA), and Non-Conformance Management.
Distinguished by its intuitive user interface, our software provides a seamless experience, allowing stakeholders to effortlessly monitor the real-time progress of various QMS activities. Notably, our solution aligns with the stringent regulatory requirements, boasting compliance with USFDA 21 CFR Part-11 guidelines and other relevant standards.
What sets our software apart is its exceptional configurability, enabling tailoring to the specific and unique needs of your Quality Management System. This adaptability ensures a bespoke approach, addressing the intricacies of your organizational processes. Furthermore, the software grants users unparalleled real-time visibility into QMS activities, allowing for swift identification and resolution of any issues that may arise. This commitment to transparency ensures that your products consistently adhere to the highest quality standards, fostering a culture of excellence within your organization.
What is the need of an eQMS system?
In many organizations, the crucial task of managing quality processes is often performed manually by a key individual, leaving the audit quality vulnerable to the absence or neglect of that person. Recognizing the superior alternative that automation presents, Quickflow's Digital Quality Management Solution offers a Commercial Off-The-Shelf (COTS) system designed to enhance efficiency and ensure superior outcomes for data integrity. This software provides a structured approach to compliance, addressing quality concerns at their source and enabling pharmaceutical businesses to strictly adhere to the rigorous requirements set by global regulatory authorities such as the US FDA, MHRA, and WHO.
The Integrated Quality Management System (QMS) features modules for CAPA Tracking, Change Control, Market Complaints, Deviation Management, Vendor Qualification, Audit Management, OOS/OOT, . Quickflow's Enterprise Quality Management Software (EQMS) system minimizes the risk of quality process failures, reduces total costs, and improves organizational compliance. Despite the numerous benefits, the transition from manual to automated processes in life sciences companies poses a question. Quickflow addresses this by offering a low code and no code-based eQMS software tailored to the automation challenges and work cultures of pharmaceutical businesses. This solution provides a comprehensive perspective on the quality management process, ensuring flexibility and compliance with stringent quality requirements such as 21 CFR Part 11, EU Annex 11, and cGMP.
Industry Challenges
⦿ Time-consuming:
Establishing and maintaining a manual QMS demands considerable time and effort, including documentation and employee training.
⦿ Prone to errors:
Human errors in manual QMS can lead to non-compliance, quality issues, and customer complaints.
⦿ Lack of real-time data:
Relying on paper-based records in a manual QMS hinders quick identification and resolution of quality issues due to a lack of real-time data.
⦿ Storage and retrieval challenges:
Physical storage of manual records can be burdensome, and retrieval becomes challenging if records are lost or damaged.
⦿ Limited analytics:
Manual records lack the data required for effective analytics and trend analysis, hindering areas for improvement identification.
⦿ Inefficiency during audits:
Manual records retrieval during audits reduces efficiency and delays the process.
⦿ Difficult to update:
Maintaining multiple manual records in the Quality department decreases efficiency.
⦿ Lack of Audit Trials:
Manual QMS systems lack the capability to capture audit trials for performed activities.
Features
⦿ Our eQMS system efficiently manages quality metrics, including Change controls, Deviations, Non-conformances, and Audit management, providing a comprehensive solution for streamlined quality processes.⦿ All QMS procedures are conveniently initiated, reviewed, and approved online, utilizing electronic signatures and activity stamps, ensuring a seamless workflow.
⦿ Enjoy the flexibility of customizable templates in our eQMS software, tailored to your specific Quality needs. Easily modify templates to reflect changes in your Quality process for enhanced efficiency.
⦿ Experience real-time tracking of QMS activities, enabling quick identification and resolution of issues, promoting proactive quality management.
⦿ Seamlessly integrate our software with other systems, such as MES, LIMS, SAP, etc., through RPA, eliminating data discrepancies and ensuring a smooth transition between platforms.
⦿ Ensure data security with role-based access controls, allowing only authorized personnel to access and modify records.
⦿ Eliminate data integrity and compliance concerns with the aid of our software, adhering to regulatory requirements.
⦿ Maintain clear audit trails and version control, transparently recording all changes made to records for enhanced traceability.
⦿ Receive automatic alerts and notifications for improved communication and timely issue resolution.
⦿ Uphold data integrity and compliance through electronic signature and validation, meeting regulatory standards.
⦿ Access historical records easily with centralized data storage, supporting reporting and analysis for informed decision-making.
⦿ Our cloud-based deployment ensures accessibility and security for all users, regardless of their location, promoting efficient collaboration.
Key Benefits
⦿ Increased Efficiency:
➮Streamlining the Quality process results in a more efficient workflow, reducing redundant tasks and saving time.
➮Process optimization minimizes errors, contributing to the overall efficiency of quality management activities.
⦿ Real-time Visibility:
➮Monitoring QMS activities in real-time provides instant insights into ongoing processes.
➮It ensures timely identification and resolution of issues, fostering consistent and high-quality outcomes.
⦿ Automated Reporting:
➮Automated report generation saves time by eliminating manual data compilation.
➮Minimizing errors in reporting enhances the reliability and accuracy of quality-related documentation.
⦿ Customizable Templates:
➮Tailoring the software with customizable templates allows organizations to align the QMS precisely with their specific needs.
➮This customization ensures that the software adapts seamlessly to the unique processes and requirements of the business.
⦿ Regulatory Compliance:
➮Ensuring compliance is facilitated through the accurate and up-to-date documentation maintained by the software.
➮The system supports adherence to regulatory standards, such as those set by agencies like the FDA or other governing bodies.
⦿ Improved Communication:
➮The software facilitates easy communication among team members involved in quality management.
➮Enhanced communication ensures better coordination, reducing the likelihood of misunderstandings and errors.
⦿ Enhanced Collaboration:
➮Promotion of collaboration between different departments improves overall efficiency.
➮Teams can work more seamlessly together, fostering a collaborative environment that reduces delays in the quality management process.
⦿ Cost Savings:
➮Saving money on production costs is achieved through the reduction of errors and streamlining of quality processes.
➮The efficiency gained contributes to cost savings by minimizing resource wastage and optimizing operational expenses.
⦿ Scalability:
➮The software's scalability allows easy adaptation to meet the changing needs of the business.
➮It ensures that the QMS can grow or evolve in sync with organizational expansions or shifts in requirements.
⦿ Reduced Paperwork:
➮Eliminating manual record-keeping reduces paperwork, mitigating associated risks such as data loss or errors.
➮The transition to a digital environment contributes to a more organized and secure documentation system.
