TCS Teamcenter for Medical Devices is a PLM solution that delivers product innovation and development capabilities in a secure environment while constantly monitoring FDA compliance. Users can create, author and modify documents and route them through intuitive workflows that capture relevant information and dynamically convert approved documents into a secure format.
The solution includes strict rule-driven product-based document control, training management, design control (including packaging, labeling and marketing materials), production and process control (via interface with MES), and application (software) control. Device Master Records (DMR) are created and managed to ensure that the design meets the requirements and that the risks are adequately captured, analyzed and controlled during the entire development cycle. Supported product features such as DHF, DHR and CAPA will provide medical device companies a single, integrated PLM platform, thereby eliminating the need to sustain multiple systems and associated infrastructure.