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An electronic Quality Management System is an absolute necessity if you want to stay competitive.

eQMS: The Only Option

For any Medical Device or ISO 13485 company today, an electronic Quality Management System is a tool that will systematize and streamline quality practices so you can get superior products to market quickly, without compromising compliance.

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Some of the benefits include:

Reduction in Company Head Count

The work and communication flows built into the eQMS reduce the number of people required for document management. And paperwork is reduced since fewer forms and checklists are needed.

Improved Communications with Suppliers and Stakeholders

Authorized individuals can be given access to only the documents they need and see changes in real time.

Optimized Scheduling Activities

asks such as Internal and Supplier Quality Audit scheduling are much easier to establish and monitor. Less time spent on these activities means your team can spend more time on value-added activities.

eQMS Helps Integrate “Quality” with Operations & Management

When the operations and management teams can access quality information via an eQMS, the importance of and attention paid to quality greatly increases, the cost of quality can be reduced, and ROI increased.

  • Automated work and communication flows drive timely communication between Quality and Operations and the appropriate level of Management.
  • Management can more efficiently see trends.
  • Accountability is much better established with an eQMS than without.

Handwritten Signatures Are Not Required

All the problems inherent in a manual change control process, such as …

  • Taking too much time and too many resources,
  • Error prone,
  • Difficulties knowing where a document is within the change control process,
  • Challenging to notify suppliers of change control activities that affect them,

are eliminated with an eQMS.

Remote Work is Optimized

Of course, product manufacturing requires on-site work. However, some work can be accomplished just as effectively, or even more effectively, remotely. Remote workers can access an eQMS from almost anywhere on the globe. All that’s required is a computer, internet connection, and eQMS access.

The Cost of Quality is Lowered

An eQMS means:

  • Planning is easier and more efficient, thus lowering the cost of prevention.
  • Training system requirements and record keeping are easier, lowering the cost of prevention.
  • Corrective and Preventive Action (CAPA) is optimized, thus reducing the cost of internal and external failures.
  • Complaint Management is optimized, reducing the cost of external failures.

are eliminated with an eQMS.

Custom Consultation

We invite you to schedule a custom consultation to discuss your specific FDA compliance issues.

We can help you determine what to do, how much it will cost, and how long it will take to make that 501(k) go away.