Compliance & Security

Built from the ground up for GxP regulated environments. We understand that compliance isn't optional.

Regulatory Framework Support

FDA

21 CFR Part 11

FDA regulations for electronic records and electronic signatures in pharmaceutical manufacturing.

  • Electronic signatures with signer identification
  • Complete audit trails for all record changes
  • Access controls and user authentication
  • Data backup and recovery procedures
EU

EU GMP Annex 11

European guidelines for computerized systems in GMP-regulated environments.

  • Risk-based validation approach
  • Supplier qualification documentation
  • Periodic review and change control
  • Business continuity planning

ALCOA+ Data Integrity

Every feature in BioWise is designed with data integrity principles at its core.

A
Attributable

Every action linked to a person

L
Legible

Clear, permanent, readable

C
Contemporaneous

Recorded at time of event

O
Original

First capture preserved

A
Accurate

Correct and truthful

Complete
Consistent
Enduring
Available

Validation Support

We provide comprehensive documentation to support your Computer System Validation (CSV) process under GAMP 5 guidelines.

  • User Requirements Specification (URS)

    Detailed requirements documentation

  • Functional Specification (FS)

    What the system does

  • IQ/OQ/PQ Protocols

    Installation, Operational, Performance Qualification

  • Traceability Matrix

    Requirements to test case mapping

GAMP 5 Category

4
Configured Product

Established software configured for use

BioWise is classified as a GAMP Category 4 system, which means validation focuses on configuration verification rather than full code-level testing.

Security Architecture

Encryption

AES-256 encryption at rest. TLS 1.3 in transit. Customer-managed keys available.

Identity & Access

SAML 2.0 / OIDC SSO. Role-based access control. Multi-factor authentication.

Audit Logging

Immutable audit trails. Who did what, when, and why. Export for regulatory review.

Multi-Tenant Isolation

Complete data isolation between tenants. Dedicated resources available.

Zero Trust Network

No implicit trust. Every request authenticated and authorized. Micro-segmentation.

Disaster Recovery

Multi-region backups. RPO < 1 hour, RTO < 4 hours. Annual DR testing.

Infrastructure & Certifications

SOC 2 Type II ISO 27001 GDPR Compliant HIPAA Ready

Hosted on AWS with EU data residency options. Infrastructure security certifications available upon request.

Questions about compliance?

Our team includes former pharmaceutical quality professionals. We speak your language.

Talk to Us