Medical Device IT Audit Readiness Checklist

How Tech River Supports FDA 21 CFR Part 11 & HIPAA-Aligned IT Controls

Download the full Medical Device IT Audit Readiness Checklist here

How to Read This Checklist

What’s Inside the IT Buyer’s Guide

How to Read This Checklist

This checklist is designed to help Medical Device and Life Science organizations assess whether their IT environment, security controls, and operational practices are prepared to support regulatory audits

It focuses on IT General Controls (ITGCs) and cybersecurity practices that auditors frequently review or request evidence for.

Each section describes:

What auditors expect
What Tech River manages or supports
What evidence can be produced during an audit

This checklist reflects Tech River’s operational approach to supporting regulated environments and should be reviewed alongside your Quality Management System (QMS) and regulatory guidance. It is intended to support audit readiness by ensuring foundational IT controls are in place and documented.

Regulatory Scope Referenced

This checklist aligns IT practices commonly associated with:

FDA 21 CFR Part 11

(Electronic Records & Signatures – IT controls support)

HIPAA Security Rule

(Administrative, Technical, and Physical Safeguards)

NIST Cybersecurity Framework

(best-practice reference)

Section 1: Access Control & Identity Management

What auditors expect:
Controlled, documented access to systems that store or process regulated data.

How Tech River supports this:

Centralized identity management using secure directory services
Role-based access controls aligned to job function
Least-privilege enforcement for users and administrators
Multi-factor authentication (MFA) for:
- Remote access
- Administrative accounts
- Cloud applications (e.g., Microsoft 365)

Audit Readiness Checklist:

All users have unique accounts (no shared credentials)
Role-based access controls (RBAC) are defined and documented
MFA enforcement is documented
User onboarding and offboarding workflows are defined
Access is removed promptly when employees or contractors leave
Access review evidence can be produced

Audit Evidence Tech River Can Provide:

Access review reports
MFA enforcement screenshots or policies
Account lifecycle documentation

Section 2: Endpoint & Device Security

What auditors expect:
Systems accessing regulated data are protected, monitored, and controlled.

How Tech River supports this:

Managed endpoint protection with advanced threat detection
Centralized monitoring and alerting
Device inventory and lifecycle tracking
Disk encryption and endpoint hardening
Controls around removable media and mobile access

Audit Readiness Checklist:

All endpoints are inventoried and tracked (laptops, desktops, servers)
Endpoint protection (AV/EDR/MDR) is deployed and monitored on all supported systems
Devices are encrypted
Security alerts are reviewed and documented
Mobile and remote access is secured

Audit Evidence Tech River Can Provide:

Endpoint inventory reports
Security monitoring summaries
Encryption status verification

Section 3: Patch Management & System Updates

Section 3: Patch Management & System Updates/strong>

What auditors expect:
Known vulnerabilities are addressed in a timely, documented manner.

How Tech River supports this:

Centralized patch management for operating systems
Regular patch cycles with reporting
Exception handling for validated systems
Visibility into patch status across the environment

Audit Readiness Checklist:

OS patching is automated or centrally managed
Critical patches are applied within defined timelines
Patch exceptions are documented and approved
Patch status reports are available

Audit Evidence Tech River Can Provide:

Patch compliance reports
Exception documentation
Update schedules

Section 4: Logging, Monitoring & Incident Response

What auditors expect:
The organization can detect, respond to, and document security incidents.

How Tech River supports this:

24/7 security monitoring of endpoints and systems
Centralized alerting and escalation
Documented incident response procedures
Incident logging and post-incident review support

Audit Readiness Checklist:

Security logs are enabled and retained
Logs are retained according to documented retention policies
Alerts are actively monitored
An incident response plan is documented and approved
Incident response roles are defined
Security incidents are documented
Evidence of response actions is retained

Audit Evidence Tech River Can Provide:

Incident response documentation
Security alert summaries
Incident timelines and reports

Section 5: Backup, Recovery & Business Continuity

Section 5: Backup, Recovery & Business Continuity/strong>

What auditors expect:
Critical data can be recovered and business disruption minimized.

How Tech River supports this:

Managed backups for critical systems
Encrypted, offsite immutable backups
Regular backup monitoring
Periodic recovery testing
Ransomware-aware recovery design

Audit Readiness Checklist:

Regular backups are performed for critical systems and data
Backups are encrypted and protected from unauthorized access
Restore testing is documented
Recovery Time Objectives (RTOs) and Recovery Point Objectives (RPOs) are defined

Audit Evidence Tech River Can Provide:

Backup success reports
Restore test documentation
Recovery procedures

Section 6: Cloud & Third-Party Systems

What auditors expect:
Cloud platforms and vendors are secured and overseen.

How Tech River supports this:

Secure configuration of Microsoft 365 and cloud services
Restricted administrative access
Monitoring of cloud activity
Support for vendor access reviews and risk discussions

Audit Readiness Checklist:

Cloud environments (e.g., Microsoft 365, Azure) are secured and monitored
Administrative access to cloud platforms is restricted and logged
Third-party vendors with system access are identified
Vendor access is reviewed periodically
Cloud security controls are documented

Audit Evidence Tech River Can Provide:

Cloud access and security reports
Administrative role documentation
Vendor access records

Section 7: Documentation & Audit Evidence Readiness

What auditors expect:
Policies exist and evidence can be produced efficiently.

How Tech River supports this:

Assistance documenting IT and security procedures
Centralized access to audit-relevant evidence
Support during audit preparation and questioning

Audit Readiness Checklist:

IT policies and procedures are documented and current
Evidence can be produced for:
- → Access reviews
- → Patch management
- → Backup verification
- → Incident response
Audit support roles (who answers what) are clearly defined
Documentation is stored centrally and accessible for audits

Audit Evidence Tech River Can Provide:

During audits, Tech River supports clients by:

Assisting with IT-related auditor questions
Providing requested documentation and reports
Helping explain security controls and processes

Final Disclaimer

This checklist is provided for informational purposes only and does not constitute legal or regulatory advice. Regulatory requirements vary, and organizations should consult appropriate compliance professionals for formal audit preparation.

Download the full Medical Device IT Audit Readiness Checklist

A WORD FROM OUR RAVING FANS

In the start-up company environment, things move fast, so you need an IT partner who understands and embraces those requirements. Corey and the team at Tech River take the time to deeply understand our company needs and respond with timely solutions to easy or complex problems. Their work is top-notch for innovation and problem-solving.

Kathy Leith, VentureMed Group

A WORD FROM OUR RAVING FANS

In the start-up company environment, things move fast, so you need an IT partner who understands and embraces those requirements. Corey and the team at Tech River take the time to deeply understand our company needs and respond with timely solutions to easy or complex problems. Their work is top-notch for innovation and problem-solving.

Kathy Leith, VentureMed Group

      EXCELLENT  
   Based on 25 reviews 
    
 
 
 
   
 
 
       Posted on Google  
   
   Amy Hansen-Douglas 
 November 17, 2024.
 
 
 Trustindex verifies that the original source of the review is Google. Chris was amazing to work with.  Patient and walked me through step by step!
  
 
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   Patty Adams 
 November 1, 2024.
 
 
 Trustindex verifies that the original source of the review is Google. Our company couldn't be happier with the decision we made to switch to Tech River. The team at Tech River is amazing. They know the technical side but are able to communicate to those of us less tech savvy. They respond quickly to any issues and work diligently to get them resolved. They offer suggestions on how to improve our systems and security and actually come onsite to onboard new team members! We would highly recommend Tech River to anyone who is looking to make a change in their IT service.
  
 
      Posted on Google  
   
   Nucleus Network 
 October 13, 2024.
 
 
 Trustindex verifies that the original source of the review is Google. I had a great experience working with Chris Kenney from TechRiver, excellent attention to details and highly professional. Our main IT Team is based overseas, in Melbourne, Australia. Chris Kept me informed with the updates throughout the project. The project was completed without any hassles and thanks to Chris to drive the project for us and achieving a positive outcome.
  
 
      Posted on Google  
   
   Lyn Burton 
 September 24, 2024.
 
 
 Trustindex verifies that the original source of the review is Google. I had the pleasure of working with Chris at Tech River, who remotely assisted me with setting up my iPad so I could use it for remote access to my office folders and files. Using ScreenConnect, he was able to walk me through downloading and configuring Outlook and other O365 apps seamlessly. He was incredibly patient and professional throughout the process. Chris even helped me set up my Zoom account, ensuring everything was functioning smoothly. The entire experience was easy and stress-free thanks to his expertise. Highly recommend their services!
  
 
      Posted on Google  
   
   Jon Althoff 
 September 13, 2024.
 
 
 Trustindex verifies that the original source of the review is Google. We partnered with Tech River for our business IT needs and they have done 100% what they promised and then more than that.  Our transition from our previous supplier was painless, and they have solved some of our longstanding problems.  Staff is attentive and reachable and explains what and why they are doing what they need to do. And as an added bonus, they are nice and fun to work with.  Additionally, they provide tests we can take to make sure we are on top of scams and technological changes.  Highly recommended.  Would definitely hire them again, no regrets in our partnering decision!
  
 
      Posted on Google  
   
   Christine Horton 
 September 14, 2023.
 
 
 Trustindex verifies that the original source of the review is Google. Absolutely appreciate the professionalism and responsiveness of Tech River (Marty) and team!  As a small company leader, I highly recommend them- they've made our company more efficient and have become a trusted partner.
  
 
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   Olivia Gadberry 
 May 19, 2023.
 
 
 Trustindex verifies that the original source of the review is Google. Tech River is a great resource for my coworkers and I. Whenever anyone on our team needs help, Tech River is there to support and take care of the issue. They are quick, friendly, and efficient. We have been working with them for almost 2 years now, and I'm sure we will continue. They make IT services affordable for non-profits like us.
  
 
      Posted on Google  
   
   Angel Foundation 
 March 23, 2023.
 
 
 Trustindex verifies that the original source of the review is Google. The addition of Tech River as our IT service provider has been a great move for us.  Their service is fast and dependable, and their customer service is terrific!  I would highly recommend them to organizations that need IT support.
  
 
      Posted on Google  
   
   Michelle Rosenthal 
 January 4, 2023.
 
 
 Trustindex verifies that the original source of the review is Google. Corey and Marty are always available when needed.  We recently transitioned to Tech River from a  larger IT support company and the implementation was flawless!  We could not be happier with our decision to work with Tech River.  They excel at understanding our needs and addressing them quickly and efficiantly!
  
 
      Posted on Google  
   
   Laura Schenck 
 December 9, 2021.
 
 
 Trustindex verifies that the original source of the review is Google. Corey and his team are very knowledgeable, very up-to-date, and very responsive. They anticipate security and platform changes and are ready with a recommendation to help protect our company and to do business more efficiently.