Security & Trust Center

ReleaseGuard is built for regulated environments. We know that passing your own security review and validation is just as important as passing an FDA audit. Here is exactly how we protect your data.

AES-256 Encryption at Rest TLS 1.3 in Transit SHA-256 File Integrity Append-Only Audit Trail

Hosting & Infrastructure

ReleaseGuard is hosted on Tier-1 cloud infrastructure (AWS) with SOC 2 Type II certified data centers.

  • Data Residency: US-East or EU-Central regions available for Enterprise customers.
  • Availability: 99.9% uptime SLA.
  • Isolation: Logical tenant isolation at the database level.

Data Encryption

All data is encrypted both in transit and at rest using industry-standard protocols.

  • In Transit: TLS 1.2+ (with HSTS enforced) for all web traffic. No plaintext communication is permitted.
  • At Rest: AES-256 block-level encryption for all database volumes and object storage.
  • Backups: Encrypted with the same AES-256 standards.

Access Controls & Auth

Strict access control is enforced at the application layer to prevent unauthorized access.

  • No Self-Registration: Accounts are provisioned solely by administrators.
  • Brute Force Protection: Accounts lock automatically after 5 unsuccessful attempts.
  • Session Management: Sessions expire automatically after 30 minutes of inactivity.
  • RBAC: Role-based access control ensures users only see what they are assigned to.

Audit Trail Immutability

Our audit trails are designed to meet ALCOA+ data integrity principles and 21 CFR Part 11 requirements.

  • Append-Only by Design: Database triggers prevent any UPDATE or DELETE operations on audit records and signatures. They are physically impossible to alter.
  • File Integrity: Every uploaded file is fingerprinted with SHA-256. If a file changes after submission, approval is refused.
  • E-Signatures: Approval-type actions require password re-entry and capture the user, timestamp, action, meaning, and file fingerprint.

Backup & Disaster Recovery

We maintain automated, encrypted backups to ensure business continuity in the unlikely event of a failure.

  • Frequency: Point-in-time recovery with daily automated backups.
  • Retention: 30-day backup retention window.
  • RTO / RPO: Recovery Time Objective (RTO) of 4 hours; Recovery Point Objective (RPO) of 1 hour.

Customer Validation Support

As a SaaS platform, ReleaseGuard provides the documentation you need to validate us within your own quality system.

  • Validation Pack: IQ/OQ templates and a Validation Master Plan (VMP) available upon request.
  • Audit Trail Export: Full CSV and PDF exports for your own internal audits.
  • Release Dossiers: One-click generation of approved file revisions, signature manifests, and checksums.

Need to complete your security review?

We can provide our SOC 2 report, penetration test summary, and validation documentation to help accelerate your procurement process.

Contact Sales Download Matrix Template