Risk Management Software

Consolidate risk by keeping your risk management file well-organized and up to date in one common and traceable system.

Link risk management to products, components, suppliers, and more

With SimplerQMS, you can link risk management documentation with products, components, suppliers, customers, and equipment.

Create dashboards to overview your current risk documentation and get an accurate representation of risk across products and processes.

Streamline your risk control process

With SimplerQMS, you can create a risk management plan and hazard analysis as part of your design control process.

Easily link risk management documents and assignments as risk control actions and design controls to reduce risks throughout the entire product lifecycle.

Access our audited ISO 14971:2019 risk management procedures and forms

Life science companies are required to have a procedure for risk management and maintain risk management documentation for their products.

In SimplerQMS, you can use our ISO 14971:2019 Risk Management procedures and forms such as Risk Management plan, Hazard Traceability Analysis, and Risk Report. This enables you to stay in compliance and work more efficiently with the new risk management standard.

Build and maintain risk management file digitally

Perform hazard analysis, record and assess risks during product development, building a risk management file intended to decrease risks and make the product as safe as possible.

When in production, continue maintaining your risk management file up-to-date throughout the entire product lifecycle. With SimplerQMS, you can electronically author, review and approve documents through an automated workflow and 21 CFR Part 11 Compliant electronic signatures.

Integrate risk-based thinking into your organization

SimplerQMS helps develop habits associated with risk management across the entire organization.

With our automated risk management software, you can minimize risks by creating and maintaining Risk Management SOPs that ensure learning activities and capture training records for the employees that need to follow them.

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.

Deviation Management Icon

Issue Management

Simplify your issue management workflows by automating tedious tasks.

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