Nonconformance Management Software
Identify, evaluate, analyze and manage nonconformances automatically and efficiently.
Decrease non-conformance cycle times with automation
SimplerQMS nonconformance management software system eliminates inefficiencies by automating your quality event processes with automated workflows.
Ensure that the relevant persons are notified when nonconformance-related tasks are assigned to them. Enable automated linking and processing of Corrective and Preventive Actions (CAPAs) using pre-defined forms. Depending on the severity, you can easily generate and assign, for completion, any number of Corrective and Preventive Actions (CAPAs).
Get a full picture of nonconformance events with KPI reports
With SimplerQMS, you can seamlessly track everyone’s progress towards their due dates through customizable Dashboards and Notifications. Quickly escalate overdue assignments to supervisors, when necessary.
Utilize built-in dashboards to overview nonconformances (NCs) by product, process, component, customer, equipment, supplier, or other data points. Easily get an overview of NC-trending by viewing automated KPI reports. Or export relevant post-market surveillance data to Excel for further analysis.
Utilize our audited nonconformance forms
With SimplerQMS, you can use our pre-configured forms for documenting nonconformance events and preparing a nonconformance report. Forms are designed to simplify common processes and help you handle nonconformance-related activities.
We provide a readily available form package, or we can help you migrate your forms and procedures into SimplerQMS.
Ensure compliance with nonconformance processes
SimplerQMS helps you stay compliant by automatically creating and storing a time-stamped audit trail of every document change.
Furthermore, our built-in 21 CFR Part 11 compliant electronic signatures and automatic workflows allow you to forget about the manual circulation of documents and chasing wet signatures.
Easily connect to all quality processes
With SimplerQMS, you can easily create hyperlinks to products, components, suppliers, customers, and equipment from any post-market surveillance issue. Upload and link any document, file, record, and email to audits, risks, and CAPAs, as evidence.
By linking different parts together and storing them in a centralized location, you will gain better visibility and be able to trace back to the root cause of each nonconformance.
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.
Issue Management
Simplify your issue management workflows by automating tedious tasks.
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.
