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
HIPAA Security Rule
NIST Cybersecurity Framework
Section 1: Access Control & Identity Management
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 Evidence Tech River Can Provide:
- Access review reports
- MFA enforcement screenshots or policies
- Account lifecycle documentation
Section 2: Endpoint & Device Security
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 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 Evidence Tech River Can Provide:
- Patch compliance reports
- Exception documentation
- Update schedules
Section 4: Logging, Monitoring & Incident Response
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 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 backup storage
- Regular backup monitoring
- Periodic recovery testing
- Ransomware-aware recovery design
Audit Evidence Tech River Can Provide:
- Backup success reports
- Restore test documentation
- Recovery procedures
Section 6: Cloud & Third-Party Systems
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 Evidence Tech River Can Provide:
- Cloud access and security reports
- Administrative role documentation
- Vendor access records
Section 7: Documentation & Audit Evidence Readiness
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 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
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.
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
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COREY CALVIN
Founder and President of Tech River
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