FRAMEWORKS
Frameworks that inform how we operate.
The frameworks below describe the standards and guidance that shape our scientific, quality, and security programs. We communicate our alignment to these frameworks accurately — separating what is independently certified from what is engineered to support or designed toward a standard.
APPLICABLE FRAMEWORKS & STANDARDS
- FDA QUALITY EXPECTATIONS
Operations engineered to support FDA laboratory quality and data integrity expectations.
- CGMP PRINCIPLES
Current Good Manufacturing Practice principles applied to controlled processes and records.
- GLP CONCEPTS
Good Laboratory Practice concepts inform study conduct, reporting, and archival.
- ISO QUALITY STANDARDS
Quality management approach aligned to widely recognized ISO management-system principles.
- ISO/IEC 17025
Structured to meet the technical and management requirements of ISO/IEC 17025 where applicable to scope.
- GAMP PRINCIPLES
Good Automated Manufacturing Practice guidance informs computerized system lifecycle management.
- DATA INTEGRITY GUIDANCE
ALCOA+ principles and international regulatory data integrity guidance applied across scientific records.
- NIST CYBERSECURITY FRAMEWORK
Cybersecurity program designed toward NIST CSF functions: Identify, Protect, Detect, Respond, Recover.
- SOC 2 (FUTURE READINESS)
Control environment built toward SOC 2 Trust Services Criteria as the program matures.
- ISO/IEC 27001 (FUTURE READINESS)
Information security management approach designed toward ISO/IEC 27001 as the program matures.
Bastion Applied Sciences continuously strengthens its quality, security, and governance programs. Certifications, accreditations, and regulatory claims are communicated accurately and only where independently achieved or officially recognized.