Effective Quality Management starts with product design and extends to service in the field. Whether in a regulated or non-regulated environment, mitigating risks and reducing the time to identify and solve quality issues is a catalyst to reduce expense and improve company success.
Quality Management doesn’t start after a product is sold. Quality starts with product design and development and encompasses the quality of incoming parts, through delivery and service. Quality should be built into a product, with a focus on solving problems as early as possible, whether in a regulated or non-regulated environment.
But it’s not easy. Challenges include lack of data control and access, slow and expensive response to quality and compliance issues, and difficulty identifying quality issues in the field.
When quality management is done well, from concept to customer, you can mitigate risks, reduce costs and drive top-line growth.
Automate and accelerate service case investigation and response to resolve issue quickly.
Collaborate closely with design and development teams to ensure products are built correctly before they ship.
Achieve and maintain compliance across global markets to secure new revenue sources.
Comply with regulations such as FDA and EU along with industry standards like ISO 13485, 21 CFR Part 11, and 21 CFR Part 820 using pre-defined templates, workflows and reports.
Resolve customer complaints and QA investigations to improve product safety and customer loyalty. Fully integrate to case management systems to leverage customer insights.
Manage CAPA, SCAR, NCMR activities with flexibility to configure forms and workflows as needed for regulatory and customer requirements.
Manage all supplier-related activities: AVL/AML, onboarding, qualification, collaboration, and corrective action.
Incorporate PLM and QMS capabilities on a single platform to enable collaboration between quality and engineering to improve quality before a product ships.
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