Get rid of the paper and work more efficiently
Discover how SimplerQMS will help your life science company save time and stay compliant.
SimplerQMS offers an all-inclusive eQMS solution for the Life Science Industry
The SimplerQMS solution is all-inclusive, which means that you will not be charged for implementation, validation, user training, support, or hosting. Everything is included and we don’t bill you by the hour. It’s that simple.
Avoid time-consuming validation
Computer System Validation is a requirement for life science companies that store and management quality records digitally. SimplerQMS provides a Pre-validated eQMS solution, which complies with the requirements of the GxP Guidelines, FDA 21 CFR Part 11 and ISO13485:2016. This means that your organization does not have to spend any time or money on system validation processes. Furthermore, we ensure continuous re-validation of the software and provide extensive validation evidence for use during audits and inspections.
What kind of validation documentation and evidence do you provide?
- Validation Procedure
- Validation Plan
- Validation Report
- IQ, OQ and PQ Documentation
Stay compliant and save time
SimplerQMS takes the full regulatory responsibility for your eQMS. Therefore, your organization does not need to invest in these specialized competencies. Our organization is ISO13485:2016 Certified and we continuously monitor the regulatory requirements and update our processes and documentation accordingly. Our customers are frequently audited by regulatory authorities and the SimplerQMS Solution has therefore been through extensive examination with a successful outcome. We are ready to participate whenever your organization is audited or inspected – and SimplerQMS is always open for audits. All regulatory documentation, such as validation reports and data retention policies are also made available to your organization.
Which standards and regulations are SimplerQMS compliant with?
- FDA 21 CFR Part 11
- ISO13485:2016 (SimplerQMS is certified by Bureau Veritas)
- FDA 21 CFR Part 820
- GxP Guidelines
- Annex 11
- EU-MDR & EU-IVDR
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.
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, nonconformance, and deviation 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.
Automate and standardize your document control activities with ease.
Have an overview of your equipment and handle tasks in an organized manner.
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.
Remain in compliance and monitor the safety and the performance of the product in the market.
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.
Establish your eQMS in 5-6 weeks
We know that your organization has limited time and resources for implementing new IT-systems. Therefore, SimplerQMS uses a fast and proven implementation method. The implementation typically takes 5-6 weeks. The implementation process starts with the analysis of your needs and continues through configuration, training, migration, and an incremental launch of SimplerQMS modules.
secure cloud hosting
Secure and scalable hosting with Microsoft Azure
SimplerQMS includes cloud-based hosting on the secure and reliable Microsoft Azure Platform. Your data is stored in state-of-the-art datacenters managed by experts. This means that your organization does not need to invest in highly specialized competencies and expensive hardware.
High level of security
The Microsoft Azure Cloud offers a high level of security. All data is encrypted at rest and during transmission. Backups are executed every 15 minutes, data is stored in multiple locations, and systems are monitored 24/7.
Certified for life science
Microsoft Azure also adheres to the necessary regulatory requirements for the life science industry. Including ISO 9001, ISO 27001, ISO 27018.
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.
Spacious and easily scalable
SimplerQMS includes space for more than 200.000 documents and 200GB of file storage. The storage capacity can seamlessly be increased if needed.
support and guidance
Get unlimited support and guidance
We understand the crucial role of the Quality Management System in your company. Efficient workflows should not be interrupted by troubleshooting or tutorial searching. For that reason, we provide unlimited customer support. You can reach us by phone or e-mail when you need help. At the same time, SimplerQMS is regularly updated to ensure regulatory compliance, security and increased efficiency.
platform and interface
Work in the familiar Microsoft Office
Our technology platform M-Files has integrations to Microsoft Office, Azure, Microsoft Dynamics, Salesforce and many more applications. More than 8.000 companies worldwide are using the M-Files platform. This means that your organization will be using a proven technology platform while harvesting the benefits of SimplerQMS’ Life Science expertise.
Only one password needed
Your users will be using the same password for logging in to Windows as for e-signing documents in SimplerQMS. This secure and user-friendly feature is included in SimplerQMS through the Microsoft Azure Active Directory technology.
With SimplerQMS you will have instant access to your documents – no matter where you are and what kind of device you are using. SimplerQMS can be used in any browser, through a Windows application, or by using our iOS or Android App.
Ready-to-use to use for Life Science
By using the ready-to-use SimplerQMS solution made specifically for Life Sciences, your organization will save time and money. We configured all of the modules, so you can efficiently manage your SOP’s, Instructions, Forms, Training Activities, Supplier Control, Technical File, Deviations, CAPAs, and much more. At the same time, you get the flexibility to build dashboards (besides using our pre-defined dashboards), configure an unlimited number of projects, archives, and products, store any file type of any size.
sop’s and templates
Save time by using pre-made procedures and templates
The SimplerQMS solution includes a template package with a Quality Manual, Procedures, Forms, and Instructions which are ISO13485:2016 and 21 CFR 820 compliant. These can be used if you don’t already have a QMS in place.
Furthermore, you will save time by adapting key procedures such as Document Control, Supplier Control, Training & Learning which are tailored for organizations that are using SimplerQMS. This means that you get ‘eQMS Compliant’ procedures, which have been audited and inspected multiple times by the regulatory authorities.
Can I also include my own templates?
Yes! It is very easy to add your own templates. You can use your current templates, mix them with the pre-made templates or only rely on the included SimplerQMS templates. Whichever suits you best.
export of documents
Export your files easily
You can easily export all your documents and files including a document index. Simply press the export button, and all the files will be transferred to your computer in an easily accessible structure. We already backup your files for you. However, this allows you to do your own backups or send document packages to external people.