QMS Software for the Life Science Industries

Streamline your quality processes with quality management software for Life Sciences – optimize workflows and stay compliant.

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Improve Life Science Quality Processes With a Complete QMS Software

It is essential for Life Science companies to manage and control documents, training, audits, and other processes in compliance with requirements to ensure the safety and efficacy of their products or services.

SimplerQMS offers complete QMS software that supports various Life Science quality management processes such as document control, change management, training management, non-conformance and deviation management, CAPA management, supplier management, and many others.

SimplerQMS offers all Life Science QMS modules, is fully validated and pre-configured, developed with Life Science requirements in mind. The system supports compliance with requirements, such as GxP, ISO 13485:2016, FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU GMP Annex 11, EU MDR and IVDR, and others.

Seamlessly Interlinked QMS Modules

By having interlinked quality management processes, you can create relations between documents and ensure seamless operations across all processes.

All QMS modules are integrated into one comprehensive quality management software designed for Life Science companies, be it a pharmaceutical, medical device, CRO, CMO, CDMO, or medical laboratory company.

Effortlessly handle your procedures, document templates, and forms throughout all quality processes. You can also utilize our complimentary template package based on the Life Science requirements if needed.

Seamless Integration with Microsoft Office Applications

SimplerQMS offers seamless integration with Microsoft Office applications, allowing you to keep working in the familiar Word, Excel, PowerPoint, and Outlook applications.

Easily edit and save documents in the SimplerQMS cloud using just a few clicks.

Eliminate the need to download and upload files manually.

Automated Actions, Notifications, and Reminders

Define timelines when creating assignments and receive automatic reminders and notifications of any necessary actions before their due dates.

Have a complete time-stamped audit trail by automatically recording all actions performed in the system.

For example, receive automatic reminders when suppliers’ certificate expiration dates are approaching to ensure timely renewal. Ensure continuous training by sending automatic email notifications to relevant personnel regarding retraining in case of document updates, and more.

Fully Validated Quality Management Software

The system is fully validated according to ISPE GAMP5 to ensure it is developed, maintained consistently, and controlled following internationally recognized guidelines.

According to requirements such as FDA 21 CFR Part 11, EU GMP Annex 11, ISO, 13485:2016, and FDA 21 CFR Part 820, many Life Science companies are required to validate the software used in the quality management system for its intended use according to an established protocol.

We ensure that the software system is re-validated upon creating a new version or applying standard updates – allowing you to save both time and money on system validation processes.

Ensure Compliance with Life Science Requirements

SimplerQMS assists Life Science companies in achieving compliance with various industry requirements such as GxP guidelines, ICH guidelines, FDA regulations, ISO standards, and more.

Streamline processes using all Life Science QMS modules, pre-configured workflows, and a complimentary template package.

SimplerQMS conforms to the guidelines of FDA 21 CFR Part 11 and EU GMP Annex 11 for electronic signatures, electronic records, and computerized systems in manufacturing.

We are also ready to assist you during your company’s audits or inspections and address any questions related to an eQMS.

Maintain Document Control with Robust Features

SimplerQMS facilitates complex document control processes, including document approvals and version control.

Ensure easy access to documents using our cloud-based system, while maintaining document integrity by defining access level to documents.

Easily locate documents by searching for specific keywords within the title and content, simplifying the document retrieval process.

Efficiently Create Documents Using Document Templates

SimplerQMS offers a range of complimentary templates that can be used to create documents.

You can customize our templates to suit your specific needs, migrate your own templates, or create templates from scratch.

Utilize templates to create essential documents, such as SOPs, work instructions, non-conformance reports, CAPA forms, audit reports, etc., while working within familiar Microsoft Office applications like Word, Excel, and PowerPoint.

Control Changes with Robust Change Control Management

Address all steps involved in change control management such as creating change request documents using templates, routing change requests for review and approval, assigning specific tasks to individuals, and so on.

Electronically sign the change request to document the justification of the change and have all the steps automatically recorded in a time-stamped audit trail.

Streamline Employee Training Management

Create detailed training plans and designate learning to specific employee roles.

Automatically notify employees of upcoming training due dates or the need for retraining.

Keep track of each employee’s training progress and generate reports on their training completion status.

Maintain up-to-date and well-documented employee training records to ensure compliance with Life Science requirements.

Ensure Effective Training with Quiz Assessments

Streamline the evaluation of training effectiveness by incorporating quizzes, and moving beyond just reading and signing documents.

SimplerQMS enables the measurement of training effectiveness through customizable quizzes presented in a multiple-choice format with pre-defined passing criteria.

Track and Resolve Complaints Effortlessly

Capture and record all necessary information about the complaint. Route the complaint to the relevant personnel or department for investigation and resolution. Easily assign tasks and set deadlines to address complaints promptly and effectively.

Efficiently Manage and Resolve NCs & Deviations

Handle quality events like non-conformances and deviations in a more efficient and organized manner.

Register the quality event, assign specific roles to the appropriate personnel, and route to review and approval.

Keep track of the status of every non-conformance and deviation via customizable views. You can also export data from these views to further analyze the trend over time.

Proactively Address Issues with CAPA Management

Easily escalate deviations and non-conformances, complaints, or audit findings to a CAPA.

Create a new CAPA document using a CAPA form template to ensure consistency and accuracy in the process. Create multiple CAPAs depending on the gravity of the issue.

Export data and analyze CAPA trends to help identify improvement areas and implement preventive actions to address issues proactively.

Effortlessly Manage Supplier-Related Processes

Manage all aspects of supplier management, including Approved Supplier Lists (ASLs), contracts, certificates, surveys, evaluations, supplier audits, and more, within a single system.

Simplify the management of supplier qualification, selection, and monitoring processes.

Assure Quality with Comprehensive Audit Management

Link individual audits to audit plans and keep track of all scheduled regulatory inspections, supplier audits, and internal audits.

Transparent Pricing for Maximum Budget Control

SimplerQMS is available as an all-inclusive annual subscription with flexible license options tailored to different roles and usage levels.

Frequently Asked Questions

What Is Quality Management System Software?

Quality management system software is a digital tool designed to help companies implement and manage quality management processes.

Which Are the Best QMS Software Solutions for Life Sciences?
Several QMS software solutions are specifically designed for Life Sciences companies operating in the pharmaceutical, medical device, biotechnological, and other Life Science industries. Each of them has its own characteristics and qualities.

What Types of QMS Software Exist?

Life Sciences companies require QMS software tailored to meet specific product types, industries, and market requirements.

What are Popular Quality Management Software Features?

Some popular Quality Management Software features include Document Control, Change Control Management, Training Management, CAPA Management, and Audit Management.

How Much Does QMS Software by SimplerQMS Cost?

The pricing of SimplerQMS is determined by the type and quantity of licenses purchased.

How Much Time Does It Take to Implement SimplerQMS?

The implementation of the SimplerQMS solution typically takes between five to six weeks.