Deviation Management Software

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

Decrease deviation turnaround times with ease

SimplerQMS deviation management software solution automates the collection of data, routing, follow-ups, and escalation of overdue activities.

Automated workflows ensure that the relevant personnel is always notified when deviation-related activities are assigned to them. Automate linking and processing of Corrective and Preventive Actions (CAPAs) using pre-defined forms. Depending on the severity, you can easily generate and assign any number of Corrective and Preventive Actions (CAPAs).

With SimplerQMS, you can quickly escalate overdue activities to supervisors, link failure incidents to related processes such as product management or electronic batch records. This means shorter deviation cycle times with less effort.

Analyze the trend of nonconformance events with KPI reports

With SimplerQMS, you can track everyone’s performance towards their due dates with the help of customizable Dashboards and Notifications.

Use built-in dashboards to overview all deviations by product, component, process, customer, equipment, supplier, or other data inputs. Easily get an overview of deviation-trending by viewing automated KPI reports.

Quickly export relevant post-market surveillance data to Excel for further, more sophisticated analysis.

Make use of our audited deviation forms

Forms prompt users to input all the necessary data points, which helps lessen the margin of error and make the right decision.

With SimplerQMS, you have a choice of utilizing our pre-configured forms and procedures for documenting deviation events and other quality processes. Or we can help you migrate your own forms and procedures into SimplerQMS.

Streamline compliance with deviation processes

The SimplerQMS solution 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 records and chasing wet signatures.

Seamlessly connect data across other 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 even an email to audits, risks, and CAPAs, as evidence.

Integrate different quality processes and store everything in a single location. This way you will gain better visibility of deviations and will be able to determine root causes more easily.

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

Issue Management

Simplify your issue management workflows by automating tedious tasks.

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