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
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.
Issue Management
Simplify your issue management workflows by automating tedious tasks.
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.
