Solutions & Services
We offer you MainEDC™ system comprising seamlessly integrated EDC, IWRS and drug supply components.
Our system qualifies as GAMP 5® category 4 - configurable systems.
DM 365 stands out for providing private cloud hosting (SaaS) for every client – there is no multi-tenant use.
The data flows are separated ensuring the highest security level.
EDC and IWRS systems are subject to validation as they are used in GxP-regulated environments.
Ultimately, the end user is responsible for validation of the system chosen.
If you are a CRO offering data management and drug supply management services or a Pharma doing these jobs on your own, we are your software supplier.
To optimize your GxP-regulated system validation effort, we share it by providing the following services and deliverables, in full compliance with all the applicable regulations and standards:
What is most important and distinguishes DM 365, is that our company is also an end user of its own software.
Yes, we do data management and you can contract us where you need an external service.
This mandates that we validate our EDC, too. So we do - having a full validation package and SOPs covering the validation process. Our clients, who we do data management for, are very welcome to audit us - we have successfully hosted quite a number of local and international qualification audits in the past 4 years.
Please check the table below to see the deliverables we share. Feel free to contact us, we will be happy to help you with the documents in case of an audit.
MainEDC™ validation package includes:
|User Requirements Specification||DM 365 for review by Client|
|Title 21 CFR Part 11 User Requirements Specification||DM 365 for review by Client|
|Functional Requirements Specification *||DM 365|
|Configuration Requirements Specification *||DM 365|
|System Design Specification *||DM 365|
|Installation Plan *||DM 365|
|Installation Qualification (virtual machine) *||DM 365|
|Installation Qualification (application) *||DM 365|
|System Installation Report *||DM 365|
|Design Review Report *||DM 365|
|Code Review Report *||DM 365|
|Unit & Integration Testing Plan *||DM 365|
|Unit and Integration Testing Summary Report *||DM 365|
|OQ Test Plan *||DM 365|
|Test Script *||DM 365|
|Test Execution Protocol *||DM 365|
|Test evidence screenshots *||DM 365|
|Traceability Matrix for OQ *||DM 365|
|OQ Testing Summary Report||DM 365|
|User Acceptance Test Scenario||Client or DM 365 (if contracted)|
|User Manual||DM 365|
|Release Note||DM 365|
Validation Summary Report and Certificate
summarizing supplier's validation activities
Validation Summary Report
summarizing end user validation activities
* Referenced in DM 365's Validation Summary Report and available for auditing when DM 365 provides both software and data management services.