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.