Good Remote Audit Practices

Define Online Compliant Processes

Design your product processes from design to release and sustaining to comply with or exceed your regulations. Regulatory bodies include ISO for any company and FDA for U.S.-market medical device companies. Each country, economic union, and industry has its own regulatory bodies as well.

Automate the Processes With Date/Time Stamps and User Information

How do you show that users and partners are following your compliant processes as designed? Logbooks and spreadsheets fall short in today’s fast-paced, high-expectation industries. Online systems automatically record users’ activities, leaving a record of who has done what and when.

“We are prepared and confident for audits. We link all QMS information and product records. We structured the data to support our processes. Everything is searchable and we can quickly find the documents and records an auditor needs.”

– Michelle J. Potvin, ASQ CQA Director, Quality
Assurance & Regulatory Affairs, Swan Valley Medical