Enterprise Security for Regulated Cloud Platforms: A Senior Leader’s Checklist

When you propose a cloud-based regulatory platform to your organization, you will face two audiences: the business stakeholders who want faster submissions, and the IT security and quality teams who want assurance that moving regulated data to the cloud does not introduce unacceptable risk. The second conversation is often the one that determines your timeline.

This is a practical evaluation checklist — the security and compliance questions you should be asking any cloud vendor before your IT and quality teams ask them for you. For each item, I have included what a strong answer looks like and where common gaps appear.

1. Data Encryption: At Rest and In Transit

What to require: TLS 1.2 or higher for all data in transit. AES-256 encryption for data at rest. Encryption keys managed through a dedicated key management service, not hardcoded or shared across customers.

What to watch for: Vendors who confirm “yes, we encrypt” without specifying the mechanism. Ask whether encryption keys are tenant-specific or shared. Ask who has access to the keys and whether you can bring your own key (BYOK) if your security policy requires it.

A strong implementation uses cloud-native key management — such as Azure Key Vault — with dedicated keys per tenant, ensuring that one customer’s data cannot be decrypted with another customer’s credentials, even in a theoretical breach scenario.

2. Multi-Tenancy Isolation

What to require: Clear documentation of how tenant data is separated. Understand the architecture: shared database with row-level security, dedicated schemas per tenant, or fully dedicated database instances.

What to watch for: Row-level security in a shared database is the most common approach and is acceptable when implemented correctly, but it requires rigorous application-layer enforcement. A defect in a query filter can expose cross-tenant data. Ask the vendor whether they have had independent security testing of their tenant isolation model.

Dedicated encryption keys per tenant add a meaningful layer of protection on top of logical data separation. Even if a query defect were to occur, encrypted data from another tenant would be unreadable without the corresponding key.

3. Identity and Access Management

What to require: Integration with your existing identity provider via LDAP or SAML-based SSO. Role-based access control (RBAC) that maps to your organizational structure. Configurable session timeouts. Secure session management including HTTP-only cookies and CSRF protection.

What to watch for: Platforms that maintain their own user database without federation to your identity provider create a governance gap. You need user provisioning and deprovisioning to flow from your central directory. When someone leaves your organization, their access to regulated submissions should terminate through the same process that disables their email — not through a separate manual step in the vendor’s admin console.

Granular RBAC matters more in regulatory than in most domains. A CRO partner reviewing Module 3 chemistry data should not have visibility into Module 1 cover letters or correspondence with the agency. Role definitions should be specific enough to enforce need-to-know access at the document level.

4. Audit Trails

What to require: Immutable, timestamped logging of every user action: document access, modifications, annotations, approvals, exports, and administrative changes. Audit records must capture the user identity, the action performed, the timestamp, and the specific data affected.

What to watch for: “Immutable” is the key word. Ask whether audit records can be modified or deleted by any user, including system administrators. Under 21 CFR Part 11, the audit trail must be tamper-evident. If your vendor’s database administrator can quietly delete log entries, that is a compliance gap regardless of what the marketing materials say.

Ask to see a sample audit trail export. The format and granularity of audit data vary enormously between vendors. A log entry that says “user edited document” is less useful than one that records the specific field changed, the previous value, and the new value.

5. Infrastructure Security

What to require: Hosting on a major cloud platform (Azure, AWS, or GCP) with documented security certifications. SOC 2 Type II compliance at minimum. Understand which data center regions your data will reside in and whether you have a choice.

What to watch for: Some vendors host on public cloud but have not implemented the security controls that the cloud provider makes available. Azure, for example, offers network security groups, private endpoints, DDoS protection, and web application firewalls — but these are configuration choices, not automatic features. Ask whether the vendor has implemented defense-in-depth at the network layer, not just at the application layer.

Multi-region deployment matters for both performance and resilience. If your teams are in the US, EU, and APAC, data served from a single US region introduces latency for international users and may raise data residency concerns under GDPR or local regulations.

6. Regulatory Compliance

What to require: Explicit compliance with 21 CFR Part 11 (electronic records and signatures) and EU Annex 11 (computerized systems). Pre-built IQ/OQ/PQ validation packages that your quality team can execute without starting from a blank template. GDPR compliance for any personal data processed in the platform.

What to watch for: Vendors who claim Part 11 compliance without being able to show you the specific controls: electronic signatures with meaning, signature-to-record binding, authority checks, and the audit trail requirements discussed above. Ask for their compliance matrix mapping platform features to specific Part 11 requirements.

Validation packages deserve particular scrutiny. A cloud-native platform with pre-validated IQ/OQ/PQ documentation can reduce your validation timeline from months to weeks. An on-premise tool that requires full revalidation with every version upgrade is a recurring cost that rarely appears in the initial vendor comparison.

7. Backup and Disaster Recovery

What to require: Documented Recovery Point Objective (RPO) and Recovery Time Objective (RTO). Geo-redundant backups stored in a separate region from the primary deployment. Regular backup testing with documented results.

What to watch for: RPO and RTO numbers without a tested disaster recovery plan are aspirational, not contractual. Ask when the vendor last executed a full disaster recovery test and what the actual recovery time was. Ask whether backups are encrypted with the same tenant-specific keys as production data.

8. Vendor Security Practices

What to require: Annual penetration testing by an independent third party, with evidence that findings are remediated. A vulnerability management program with defined SLAs for patching critical vulnerabilities. A documented incident response plan with defined notification timelines.

What to watch for: Penetration testing performed by the vendor’s own team is not independent testing. Ask for the name of the third-party firm and the date of the most recent test. Ask whether you will be notified of security incidents that affect your data and within what timeframe. Regulatory submissions contain confidential commercial information — a breach notification that arrives after your next FDA meeting is not acceptable.

The Questions You Should Be Asking

Before signing with any cloud regulatory technology vendor, put these questions in writing and require written answers:

  • Can you provide your SOC 2 Type II report? Not a summary — the full report.
  • How is my data isolated from other tenants, and has this isolation been independently tested?
  • What happens to my data if we terminate the contract? Data export format, timeline, and certified deletion.
  • What is your patch management SLA for critical vulnerabilities?
  • Can you provide your 21 CFR Part 11 compliance matrix?
  • When was your last third-party penetration test, and were all critical findings resolved?
  • What is your contractual notification timeline for security incidents affecting my data?
  • Do you support customer-managed encryption keys?

The vendors who can answer these questions quickly and specifically are the ones who have invested in security as a core capability. The ones who need weeks to compile responses are telling you something about their organizational maturity. Listen to that signal.