Customer, Supplier and Internal Audits
Remote and Hybrid Audits
More audits now happen partly or fully at a distance. Certification bodies, notified bodies and MDSAP auditing organizations use remote techniques, and FDA conducts remote regulatory assessments. The quality questions are the same, but the way you present evidence changes.
At a Glance
- Used by
- Certification bodies, notified bodies, MDSAP auditing organizations, customers and FDA
- FDA format
- Remote regulatory assessments, which FDA describes as separate from inspections
- Methods
- Video calls, screen sharing, document sharing and live camera walkthroughs
- Main risks
- Connectivity, document readiness and confidentiality
What It Is
A remote audit uses video calls, screen sharing and shared documents in place of some or all of the time on site. A hybrid audit mixes the two, for example a remote document review followed by a shorter visit to see production areas.
Certification bodies, notified bodies and MDSAP auditing organizations use remote and hybrid methods where their rules allow. FDA has its own approach: remote regulatory assessments, which FDA describes as separate from inspections, can include requests for records and virtual meetings.
Remote doesn't mean lighter. Without the walk-around, auditors rely more on records, so document readiness matters more. Screen sharing also brings its own risks, like showing the wrong file or exposing confidential information.
Who Conducts It
The same organizations that audit on site: certification bodies, notified bodies, MDSAP auditing organizations, customers auditing their suppliers, and FDA through remote regulatory assessments. Each sets its own rules for when remote methods are used and what still has to be seen in person.
On your side, add an IT lead to the usual hosting roles, plus someone whose only job is to manage what's on screen.
What Triggers It
- Audit bodies choosing remote or hybrid formats for document-heavy portions of an audit
- Distant sites, travel limits or scheduling constraints
- FDA remote regulatory assessments, such as requests for records
- Supplier audits where a remote review is adequate for the risk
- Follow-up audits that verify closure of earlier findings
What They Look At
Records Shown Live
Auditors may ask to see records in your own systems and follow the links between them as you navigate.
Document Readiness
Whether requested documents are current, approved and available quickly in readable form.
Live Process Views
Camera walkthroughs of production, storage and labeling areas where on-site observation isn't possible.
Interviews Over Video
The same questions as on site, with fewer visual cues and more need for concise answers.
Electronic Records Controls
Access controls, version control and audit trails in the systems you share, which become visible on screen.
Confidentiality and Data Handling
What is shared, how it's transmitted, and whether the auditor keeps copies.
How to Prepare
- 01
Test the Technology
Try the actual platform, cameras and connections with the auditor's tools before the audit, including from the production floor.
- 02
Stage Documents in Advance
Prepare a controlled index of likely requests so files open quickly instead of being searched for live.
- 03
Set Screen-Sharing Rules
Share a single window, close unrelated files, silence notifications and have a second person watch what's shown.
- 04
Agree on Confidentiality
Agree in writing how documents will be shared, whether copies may be kept and how they'll be protected.
- 05
Plan Live Walkthroughs
Script camera routes through production and storage areas, and check lighting, sound and network coverage.
- 06
Rehearse Remote Interviews
Practice answering on video, where pauses feel longer and people tend to over-explain.
Common Pitfalls
- Sharing a full screen and exposing email, chats or unrelated files.
- Searching for documents live while the auditor waits.
- Connectivity that drops on the production floor during a walkthrough.
- Sending documents by email with no record of what was provided.
- Experts joining from noisy locations or without access to the records they need.
How QMSAdvisor Helps
- A document library that preserves original files with a SHA-256 fingerprint for each one, so the version you share is the version on file.
- An AI-assisted first pass that flags gaps and duplicate files before an auditor asks for them.
- FDA Inspection Simulator sessions with document request clocks, so the back room practices fast, accurate retrieval.
- Advisor-reviewed findings and an action plan for closing gaps before the remote session.
Full Audit Readiness Assessment
Documents, records, evidence and interviews, checked against the specific audit you're facing next.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Software Validation and Device Software (CSV, IEC 62304)
Validate software used in production and the QMS, and build device software on an IEC 62304 lifecycle.
Standards and Regulations Involved
Questions About the Remote and Hybrid Audits
Is an FDA remote regulatory assessment an inspection?
FDA describes remote regulatory assessments as separate from inspections. They can include records requests and virtual meetings, and FDA can still conduct an on-site inspection.
Do remote audits count the same as on-site audits?
That depends on the audit body and its rules. Certification bodies, notified bodies and MDSAP auditing organizations each set when remote methods can be used and what still requires a visit, so ask before planning around a remote format.
How do we protect confidential information?
Agree in advance how documents are shared and whether copies are kept, share single windows rather than full screens, and keep a log of what you provided. Treat the session like any other controlled disclosure.
Are remote audits easier?
Usually not. With no walk-around, auditors lean harder on records, and slow retrieval or a poor connection stands out. Preparation tends to matter more, not less.
Related Audits and Inspections
MDSAP Audit
One audit by a recognized auditing organization that covers several participating regulators, including FDA.
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
Supplier Audit
Audits you perform of your own suppliers and contract manufacturers as part of purchasing controls.
Mock Audit and Mock Inspection
A realistic practice inspection, with an advisor playing the FDA investigator, before the real one arrives.
Request an Assessment
Prepare for Your Remote and Hybrid Audits With an Advisor
Tell us what's coming and when, and an advisor will scope readiness work around it. Please don't send confidential documents yet: secure upload is set up after onboarding.
