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Lead Digital Transformation in Your Organization
Empower your organization with the tools they need to get more work done, faster, in compliance with the regulatory requirements.
challenge
Complex implementation and integration
A good QMS software solution should have the flexibility to integrate with your current systems and applications. Ideally, you want to choose a vendor that fits your current infrastructure, this way you minimize the risk, uncertainty, and amount of work when implementing the system.
solution
Microsoft based infrastructure
SimplerQMS can easily be connected to Microsoft Azure Active Directory (Azure AD) for single sign-on and user data management.
The system allows you to work with all the familiar Office applications like Word, Excel, and PowerPoint, thanks to its integration with Microsoft Office 365.
Documents are simply edited in the Microsoft Office interface and saved with one click in SimplerQMS. This means you don’t have to download, edit, and upload the document every time you make a change.
solution
Seamless integration with other applications
SimplerQMS can easily be integrated with other systems like Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Product Lifecycle Management (PLM), Warehouse Management System (WMS).
We also provide an application programming interface (API). The API makes it possible to access SimplerQMS from within scripting environments. This means you can integrate SimplerQMS with many other applications.
challenge
Lack of security and regular backups of data
Undoubtedly, one of the biggest concerns in any IT department is the security of the data. Data must be encrypted, and data backups need to be regular. Servers should also be regularly updated and maintained by qualified professionals to assure steady performance.
solution
Trusted technology platform with M-Files
SimplerQMS is built on robust and disaster-proof technology by leveraging the M-Files Document Management platform as the core of its system. M-Files technology platform serves over 5,000 customers across 100 countries. It is well developed and tested to reach the highest levels of reliability and efficiency.
solution
Secure and scalable hosting with Microsoft Azure Cloud
SimplerQMS uses the highly secure Microsoft Azure Cloud Storage solution. Servers are regularly updated and maintained by qualified professionals to assure steady performance. This guarantees an up-to-date, reliable service with no additional workload on your side.
challenge
Issues with regulatory compliance
You do not want to put the responsibility of meeting the specific compliance requirements of the QMS software and its processes on yourself, such as Computer Software Validation and requirements for Electronic Signatures.
solution
Full regulatory compliance
SimplerQMS is ISO 13485:2016 certified and offers a software solution that is in complaince with 21 CFR Part 11, ISO 13485, 21 CFR Part 820, GAMP5, cGMP, GxP, EU MDR, and others.
Our cloud storage and technology platform providers, Microsoft Azure Cloud and M-Files, also adhere to the necessary regulatory requirements for the life science industry, such as ISO 9001:2015, ISO/IEC 27001:2013, and ISO/IEC 27018:2014.
solution
Continuous system validation
SimplerQMS software solution is pre-validated, it fulfills the computer system validation requirement of the GxP guidelines, FDA 21 CFR Part 11, and ISO 13485:2016.
This means that your IT department does not have to spend any time or resources on system validation processes.
modules
The SimplerQMS modules cover all your processes
No matter if your life science organization is a start-up or a later-stage company, our integrated modules cover your needs. All of the modules are included in the SimplerQMS subscription.
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.
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.
Featured Case Study
From Paper to Digital Workflows in 1 Month
Reapplix is a regenerative medicine company that helps people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.
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.
