Document Control Software
Automate and standardize your document control activities with ease.
Work efficiently in Microsoft Office
Get your organization up and running fast on SimplerQMS. We seamlessly integrate with the familiar Microsoft Office applications – Word, Excel, Outlook, and PowerPoint. Work on your documents in Microsoft Office and store them with one click in SimplerQMS Cloud. Documents are automatically named, numbered, and versioned. This will save you time, improve your documentation structure and provide a better overview.
Out-of-the-box regulatory compliance
SimplerQMS ensures compliance with the relevant standards and regulations in the life science industry. We provide an audit trail, versioning, and e-signatures, which are 21 CFR Part 11 and GxP Compliant. Furthermore, SimplerQMS is pre-validated and certified according to ISO13485:2016. This means that your organization can avoid paper documentation and manage any record electronically in SimplerQMS.
Standardize documentation processes
Enforce the use of standardized and approved forms which are created by Microsoft Office. This allows users to easily draft new documents such as instructions, supplier reviews, design records, complaints, and CAPA’s based on your customized forms.
Automate and enforce document access
Ensure that the right people have access to the right documents. Access rights are automatically set on each document and can be controlled on many levels such as by Role, Site, Project, and Department.
Simplify review and approval processes
Automated workflows ensure that the relevant persons are notified when they are assigned a task such as a document review or approval. Tasks are easily tracked through customizable Dashboards and Notifications. This allows you to quickly gain an overview of documentation status. Finally, let any internal or external person sign documents with our built-in Part 11 Compliant eSignatures. This means no more chasing signatures and manual circulation of documents.
Looking for more modules?
Regardless of the stage of your Life Science organization, our integrated software modules cover all your needs.
Save time with automated training activities, learning overview, reminders, and generation of training certificates.
Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.
Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.
Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.
Manage all the necessary processes related to product design and meet design control requirements with ease.
Simplify your issue management workflows by automating tedious tasks.
Manage your equipment calibration schedule and automatically assigns tasks before due dates.
Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.
Plan and organize all your product management activities and integrate them with other processes.
Automate your audit-related activities and ensure better audit preparedness.
Consolidate risk and handle your risk management file in a well-organized and structured manner.
Simplify supplier-related activities and handle your supplier documentation following the standards.
Standardize your documentation processes and boost employee productivity with effective document forms.
Streamline the investigation, documentation, and resolution of all your deviations.
Electronic Batch Records
Digitize and automate your batch record processes to ensure regulatory compliance.
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.