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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 Module Icon

Training Management

Save time with automated training activities, learning overview, reminders, and generation of training certificates.

CAPA Management Icon

CAPA Management

Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.

Complaint Management Module Icon

Complaint Management

Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

Design Control Module Module Icon

Design Control

Manage all the necessary processes related to product design and meet design control requirements with ease.

Document Management Module Icon

Document Control

Automate and standardize your document control activities with ease.

Equipment Calibration Icon

Equipment Calibration

Manage your equipment calibration schedule and automatically assigns tasks before due dates.

Electronic Signature Module Icon

Electronic Signatures

Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.

Product Lifecycle Management Icon

Product Lifecycle

Plan and organize all your product management activities and integrate them with other processes.

Audit Management Icon

Audit Management

Automate your audit-related activities and ensure better audit preparedness.

Risk Management Icon

Risk Management

Consolidate risk and handle your risk management file in a well-organized and structured manner.

Supplier Management Module Icon

Supplier Management

Simplify supplier-related activities and handle your supplier documentation following the standards.

Form Management Icon

Form Management

Standardize your documentation processes and boost employee productivity with effective document forms.

Deviation Management Icon

Deviation Management

Streamline the investigation, documentation, and resolution of all your deviations.

Electronic Batch Records Icon

Electronic Batch Records

Digitize and automate your batch record processes to ensure regulatory compliance.

Nonconformance Management Icon

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.

SimplerQMS Demo Interface