Issue Management Software
Monitor the safety and performance of your products with effective issue management processes.
Automate and simplify your issue management processes
With the SimplerQMS issue management software system, you can easily automate data collection, routing, and escalation of overdue activities.
Our automated workflows ensure that the right persons are notified when tasks are assigned to them. The system records audit findings, non-conformances, deviations, complaints, and other issues with automated linking and processing of Corrective and Preventive Actions (CAPAs) using pre-defined forms. Depending on the severity, you can generate and assign any number of Corrective and Preventive Actions (CAPAs).
Uncover trends in your quality data with KPI reports
SimplerQMS issue management software solution allows you to easily track the assignment of each person through customizable dashboards and notifications.
Utilize built-in dashboards to gain an overview and better understand what is impacted by each post-market surveillance issue. Analyze complaints by product, component, process, customer, equipment, and supplier in the system. Get an overview of issue-trending by viewing automated KPI reports. Or, export relevant post-market surveillance data points to Excel for further analysis.
Streamline compliant issue management activities
SimplerQMS facilitates compliance regarding issue management processes by automatically creates and stores time-stamped audit trails of every document change.
Furthermore, our solution provides built-in 21 CFR Part 11 compliant electronic signatures and automatic workflows. This means no more manual circulation of documents and chasing wet signatures.
Seamlessly integrate data with other quality processes
SimplerQMS issue management software allows for seamless linking of any post-market surveillance issue to products, components, customers, suppliers, and equipment management.
Easily upload and hyperlink any document, record, file, and email to CAPAs, audits, and risks, as evidence. By storing data in a centralized location and integrating other quality processes, in SimplerQMS, you will gain more visibility and will be able better equipped when determining the root cause of any issue.
Looking for more modules?
Regardless of the stage of your Life Science organization, our integrated software modules cover all your needs.
Training Management
Save time with automated training activities, learning overview, reminders, and generation of training certificates.
CAPA Management
Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.
Complaint Management
Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.
Change Management
Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.
Design Control
Manage all the necessary processes related to product design and meet design control requirements with ease.
Document Control
Automate and standardize your document control activities with ease.
Equipment Calibration
Manage your equipment calibration schedule and automatically assigns tasks before due dates.
Electronic Signatures
Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.
Product Lifecycle
Plan and organize all your product management activities and integrate them with other processes.
Audit Management
Automate your audit-related activities and ensure better audit preparedness.
Risk Management
Consolidate risk and handle your risk management file in a well-organized and structured manner.
Supplier Management
Simplify supplier-related activities and handle your supplier documentation following the standards.
Form Management
Standardize your documentation processes and boost employee productivity with effective document forms.
Deviation Management
Streamline the investigation, documentation, and resolution of all your deviations.
Electronic Batch Records
Digitize and automate your batch record processes to ensure regulatory compliance.
Nonconformance Management
Identify, evaluate, analyze and manage nonconformances more efficiently.
Trusted by companies around the world
Ready to learn more?
To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.
