Solutions & Services

Enjoy Your Validation!

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:

  • Formalized User Requirements Specification (URS) for MainEDC, including 21 CFR Part 11 requirements for e-records and e-signatures. You can review and approve the URS and base your validation plan on it.
  • Deployment of your own private cloud instance with Installation Qualification (IQ) documentation.
    Further on we will install testing environment of MainEDC on it and grant you access to a test project so that you do the Performance Qualification (PQ).
    Once you are happy with the results, you can start building your real projects.
  • As soon as you are ready to go to production, we will install production environment of MainEDC on your own private cloud. All system installations are accompanied with System Installation Reports, summarizing actions performed.
  • Validation never ends, so you will continue doing performance qualification in your own projects, once you have configured them.
  • We will make sure that all components of our computerized system validation process are in place - we will train you before granting you access and we will do everything according to our Quality Management System's and all applicable regulations and industry standards.
  • Release of every new system version comes along with a newly deployed instance. Whats remarkable - DM 365 maintains every instance until the last active project, the upgrade of the system version is not imposed. Every system version in use is subject to validation as frequently as you find convenient.

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:

Document Authored by
Validation Plan Client
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
DM 365
Validation Summary Report
summarizing end user validation activities
Client

* Referenced in DM 365's Validation Summary Report and available for auditing when DM 365 provides both software and data management services.