Biotechnology Firm Meets ISO 9001 Requirements Using Intelex Quality Management Software
Product
- Intelex Quality Management system
Tech Stack
- Not mentioned
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Digital Expertise
- Productivity Improvements
Applicable Industries
- Life Sciences
Applicable Functions
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
Services
- System Integration
- Training
About The Customer
The customer in this case study is a biotechnology firm. The firm was looking to become ISO 9001 compliant to facilitate potential certification in the future. They needed to implement a Quality Management system for approximately 150 users to stabilize the company’s business processes. The firm was also looking to replace paper-based processes and eliminate inefficiencies when creating and distributing relevant documentation. They required a system that would ensure criteria is met regarding acceptable documentation by the FDA (CFR part 11). The firm also wanted a system that could support the reorganization of the company and its evolving needs.
The Challenge
The biotechnology firm was looking to become ISO 9001 compliant to facilitate potential certification in the future. They needed to implement a Quality Management system for approximately 150 users to stabilize the company’s business processes. The firm was also looking to replace paper-based processes and eliminate inefficiencies when creating and distributing relevant documentation. They required a system that would ensure criteria is met regarding acceptable documentation by the FDA (CFR part 11). The firm also wanted a system that could support the reorganization of the company and its evolving needs.
The Solution
The firm implemented Intelex’s Quality Management system. They placed a special focus on Document Control and have loaded over 3,000 documents to date. The firm received extensive ongoing support including responsive and knowledgeable client services representatives, free online refresher training courses, and a convenient online resource library. Tailored on-site training provided full access users with the necessary skills to meet the needs of the organization’s implementation objectives and effectively train lower level users. The firm is currently rolling out nonconformance management, audits management, and communication tracking to support the ongoing restructuring initiatives of the organization.
Operational Impact
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