What is SaaS QMS?

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SaaS QMS Definition

SaaS QMS is a cloud-based quality management system software. SaaS QMS is sold under a pay-as-you-go subscription model. This reduces long-term capital expenses and provides businesses a quicker payback period on their investment.

SaaS QMS is used primarily by companies in the life sciences industry to streamline product development and quality processes and establish compliance with regulatory standards (e.g., FDA, ISO, EU MDR). It facilitates real-time communication across dispersed teams and enables greater visibility and traceability throughout the entire product lifecycle. This helps prevent quality issues and minimizes compliance risks for faster product commercialization.

FAQs

What is a QMS platform?

A QMS platform provides organizations a controlled and automated way to electronically manage product information and quality processes throughout the product lifecycle. By bringing quality records and the entire product design into one shared system, teams gain greater visibility into product nonconformities which enable them to improve performance and drive greater customer satisfaction while complying with FDA, ISO, and other regulatory standards.

What is quality management in PLM?

Quality management enables companies that are subject to medical device, export controls, environmental, and/or other safety regulations to streamline compliance. By linking corrective and preventive actions (CAPAs) and other quality processes directly to the product record, teams gain greater visibility into product issues, accelerate resolution, and drive continuous improvement throughout the product lifecycle.

What are the different types of QMS?

The following standards are commonly used as the basis for establishing a QMS:

  • ISO 9001
  • AS9100
  • ISO 13485
  • IATF16949

Organizations will choose the QMS that best applies to their industry and products.

Ultimate Guide to QMS

Read our best practice article to learn everything you need to know about quality management systems (QMS).

Read Article

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