Certified Quality

"DDi, a Software products/solutions provider, is committed to continually improve the efficiency and effectiveness of our resources and working systems to give most efficient, consistent and high quality software products & services ensuring customer satisfaction and confirming to the requirements of interested parties, and applicable legal & other compliance obligations. "

  • From leadership to every employee at DDi, we are committed to superior quality in our software products and services we provide to customers worldwide.
  • We carry the letter and the spirit of quality in our work. Our commitment to quality is demonstrated in two main categories - compliance to industry standards and software development quality standards.

Commitment to GxP and Regulatory Standards:

  • All DDi platforms are compliant with US FDA 21 CFR Part 11 and Eudralex Volume 4 Annex 11.
  • DDi will deliver a project, which will be tested for acceptable quality. The quality standards and customer satisfaction criteria are established for the project deliverable.
  • Computer system validation is performed according to GAMP 5 guideline in order to comply with 21 CFR part 11 and EU & GXP.
  • DDi offers audit support for regulatory inspections and client audits.

Commitment to International Quality Standards & Service management:

  • DDi quality management system is compliant with ISO 9001:2015 standard to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
  • DDi develops software following ISO/IEC 12207 standard.
  • DDi Data Centers for Hosting services are SOC and ISO 27001 certified and provide assurance to customers.
  • IT Service Management is ISO ICE 20000 certified. Service desk team provides 24/7 support.
  • Well defined procedures for Disaster recovery, Data backup and business continuity management are available and being followed. Excellent infrastructure to replicate and synchronize data between the primary and DR data centers on hourly basis.
  

 

FDA 21 CFR PART 11

 
  

 

Gamp 5

 
  

 

IT Service Management ISO ICE 20000

 
  

 

ISO 9001:2015 Standard

 
  

 

Information Security Management System ISO 27001 Standard


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