VIRTUAL QUALITY SYSTEM IMPLEMENTATION IN 7 STEPS

Below are the seven steps required to implement a successful Virtual QMS:
  • Users that connect to your files and are qualified per 21 CFR 820 and ISO 13485.
  • Laptops & internet so users can connect to your files.
  • Document(s) approved using electronic signature that is compliant to FDA 21 CFR Part 11.
  • Quality record(s) stored on a cloud-based service that is compliant to FDA 21 CFR Part 11.
  • Records organized in a logical order that supports change control and records management/retention.
  • Quality procedures, forms and logs that are compliant to 21 CFR 820 and ISO 13485.
  • Efficient document filing structure.

Virtual Quality System

Implementation Made Simple

Streamlined Virtual QMS implementation designed specifically for small and startup medical device companies seeking regulatory compliance.

7-Step Implementation Process

Below are the seven steps required to implement a successful Virtual QMS that ensures compliance with FDA 21 CFR 820 and ISO 13485 standards.

Implementation Steps

Your roadmap to Virtual QMS success

1

Qualified Users

Users that connect to your files and are qualified per 21 CFR 820 and ISO 13485, ensuring proper training and competency for quality system management.

2

Technology Infrastructure

Laptops & internet connectivity so users can seamlessly connect to your files and maintain continuous access to quality documentation.

3

Electronic Signatures

Document(s) approved using electronic signature that is compliant to FDA 21 CFR Part 11, ensuring legal validity and traceability.

4

Cloud-Based Storage

Quality record(s) stored on a cloud-based service that is compliant to FDA 21 CFR Part 11, providing secure and accessible documentation.

5

Records Organization

Records organized in a logical order that supports change control and records management/retention, ensuring efficient retrieval and compliance.

6

Compliant Documentation

Quality procedures, forms and logs that are compliant to 21 CFR 820 and ISO 13485, providing the foundation for your quality system.

7

Document Structure

Efficient document filing structure that streamlines access, reduces search time, and maintains organizational consistency across all quality documents.

Ready to Implement Your VQMS?

Let's discuss how these 7 steps can transform your quality management system and ensure regulatory compliance.

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