Challenge
- Wanted to be IS0 9001:2000 compliant to facilitate the possibility of certification in the future.
- Needed to implement a Quality Management system, involving approximately 150 users, to stabilize the company’s business processes.
- Needed to replace paper-based processes and eliminate inefficiencies when creating and distributing relevant documentation.
- Required a system that would ensure criteria is met regarding acceptable documentation by the FDA (CFR part 11).
- Wanted a system that could support the reorganization of the company and its evolving needs.
Solution
- Implemented Intelex’s Quality Management system.
- Special focus on Document Control (loaded over 3,000 documents to date).
- Extensive ongoing support including responsive and knowledgeable client services representatives, free online refresher training courses and 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.
- Currently rolling out nonconformance management, audits management and communication tracking to support the ongoing restructuring initiatives of the organization.
Results
Achieved compliance with ISO 9001: 2000 regulations.
The Quality Management system has successfully stabilized the company’s business processes Ability to centrally maintain and retrieve documentation according to restructured company policy.
Document Control system effectively enabling compliance with FDA regulations (CFR part 11) regarding electronic records and signatures.
Confident in the implementation of nonconformance management, audits management and communication tracking to meet the developing needs of the company.
