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How SDIX Achieved ISO 9001 and FDA Compliance with Digital QMS
For over 30 years, SDIX (formerly known as SDI) has been a leading immuno-solutions company, developing innovative antibody-based solutions that help customers worldwide achieve high-performance diagnostic and commercialization objectives.
Impact
- Achieved ISO 9001 compliance, ensuring standardized quality management.
- Stabilized business processes through an efficient Quality Management System.
- Centralized document control, streamlining retrieval and policy adherence.
- Ensured FDA (CFR Part 11) compliance for electronic records and signatures.
Outcome
SDIX successfully achieved ISO 9001 compliance and stabilized business processes while effectively managing documentation according to FDA regulations using Intelex's Quality Management System.
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The Challenge for SDIX
Prior to implementing Intelex, SDIX faced significant challenges with quality management processes. The company relied on inefficient paper-based workflows for creating and distributing critical documentation, making it difficult to maintain consistent standards.
As a biotechnology firm, SDIX needed to comply with strict FDA regulations (CFR Part 11) for documentation control, but their existing system was inadequate for ensuring compliance.
Additionally, SDIX underwent company reorganization and required a flexible, scalable system that could support 150 users while providing stability and facilitating future ISO 9001 certification.
“The Intelex QMS and their top-notch customer support have helped us build super-efficient and extremely effective Quality System processes to help our organization move forward at a faster pace.”
Jason Usilton, Quality Supervisor, SDIX
“Intelex has taken our questions and concerns to heart and helped customize systems that work for us.”
Jason Usilton, Quality Supervisor, SDIX
How Intelex Helped SDIX
Intelex provided SDIX with a comprehensive quality solution, with a focus on Document Control, enabling them to upload and manage over 3,000 documents.
Key benefits included:
- Tailored on-site training for full-access users, equipping them to train additional employees.
- Elimination of paper-based processes, replacing them with a centralized, digital documentation system.
- Ensured FDA compliance for electronic records and signatures, strengthening regulatory standing.
- Ongoing support, including client service representatives, free refresher courses, and an online resource library.