DKMS Quality Management System Implementation

Five-year partnership ensuring FDA compliance and operational excellence for a leading stem cell donor registry

Client

DKMS

Year

2019-2024

Services

QMS Implementation & Validation, MasterControl System Administration, FDA Compliance Advisory, Regulatory Audit Support

The Challenge

DKMS faced the complex challenge of implementing a comprehensive electronic Quality Management System (eQMS) in a highly regulated environment. As a tissue establishment subject to FDA regulations including 21 CFR Parts 11, 210, 211, 820, 1270, and 1271, DKMS required a system that could handle document control, training management, and audit readiness while maintaining the agility needed for their life-saving mission. The organization needed more than just software implementation—they required ongoing system administration, quarterly validation to keep pace with MasterControl's release cycle, and expert guidance to prepare for and respond to FDA inspections. With lives depending on the accuracy and compliance of their operations, there was zero tolerance for quality failures or regulatory violations. The existing manual processes were creating bottlenecks: document approvals took up to two weeks, training compliance hovered at only 60%, and preparing for regulatory audits consumed significant resources from the Quality team.

Our Solution

DigiForm established a five-year partnership with DKMS, serving as their dedicated QMS implementation and administration partner. Our team worked closely with DKMS's Quality department, which reported directly to executive leadership, to deploy and continuously optimize MasterControl's Documents and Training modules. We led the initial MasterControl implementation with comprehensive system validation following IQ/OQ/PQ protocols, ensuring 21 CFR Part 11 compliance for electronic records and signatures. Beyond implementation, DigiForm provided day-to-day system administration services, including user management, workflow optimization, and system configuration changes. MasterControl releases quarterly updates, and DigiForm established a streamlined validation process that included risk assessment of new features, validation protocol execution, regression testing, and documentation—ensuring DKMS remained in a continuous state of compliance. We also provided critical support for FDA inspections and regulatory audits, including pre-audit system health checks, audit trail reviews, real-time support during inspections, and post-audit CAPA implementation.

“

DigiForm has been an invaluable partner in maintaining our Quality Management System. Their deep expertise in both MasterControl and FDA regulations gave us confidence that our system would stand up to regulatory scrutiny. The efficiency gains we achieved—cutting document approval time from two weeks to two days—allowed our Quality team to focus on strategic initiatives rather than administrative bottlenecks. Over five years, DigiForm has proven to be more than a vendor; they're a trusted extension of our team.

Hannah De Simone

Quality Leadership, DKMS

Key Results

Reduced document approval time from 14 days to 2 days (86% improvement)
Improved training compliance from 60% to 100%
Zero FDA compliance incidents over 5 years
Completed 20 quarterly validations on schedule
Successfully supported multiple FDA inspections with no major findings
Streamlined audit preparation time by 70%

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