Biotechnology Firm Meets ISO 9001 Requirements Using Intelex Quality Management Software
产品
- Intelex Quality Management system
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Digital Expertise
适用行业
- 生命科学
适用功能
- 质量保证
用例
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
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.
挑战
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.
解决方案
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.
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