Nonconformance Management Software

Identify, evaluate, analyze and manage nonconformances automatically and efficiently.

Nonconformance Management Software

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.

Nonconformance Management Software Interface

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 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.

Deviation Management Icon

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.

SimplerQMS Demo Interface