Information Security
ISO/IEC 27001
Surveillance Audit
QMS Overview
CAPAManage corrective and preventive actions
Change RequestReview and control quality changes
DeviationTrack and resolve process deviations
IncidentRecord and investigate quality incidents
Audit ManagementPlan and manage audit activities
Vendor ManagementMonitor supplier quality and compliance
Customer ComplaintCapture and resolve customer concerns
Quality IssuesCentralize and resolve quality issues
OOS/OOTInvestigate out-of-specification results
eLogsMaintain secure electronic records
Also in Products
Document Management
Training Management
Certificates
Built on Security, Privacy and Trust
At Astakenis, we understand the importance of protecting critical business and quality information.
Astakenis OneQMS is designed for organizations that operate in highly regulated and quality focused environments. Our approach to security, privacy, and compliance reflects our commitment to protecting information and maintaining trusted processes.
Our Certifications and Compliance
SOC 2 Type II
Our SOC 2 Type II certification demonstrates our commitment to established controls and practices for security, availability, and protection of customer information.
It reflects our focus on maintaining consistent and controlled processes across our technology and operations.
General Data Protection Regulation
Astakenis follows General Data Protection Regulation requirements and principles for the responsible handling and protection of personal data.
Our approach supports data protection, privacy, transparency, and appropriate control over personal information.
Health Insurance Portability and Accountability Act
Our Health Insurance Portability and Accountability Act compliance supports the appropriate protection and handling of protected health information where applicable.
We follow safeguards and processes designed to support the security and confidentiality of sensitive information.
ISO 9001:2015 Certified
Our Quality Management System is certified to ISO 9001:2015, demonstrating our commitment to consistent quality, customer satisfaction, and continual improvement.
Our quality practices are built around well-defined processes, documented controls, risk-based thinking, and ongoing performance improvement.
ISO/IEC 27001:2022 Certified
Our Information Security Management System is certified to ISO/IEC 27001:2022, reflecting our commitment to protecting customer information and maintaining strong information security practices.
We follow structured controls for information security, risk management, access control, data protection, and continual improvement of our security processes.
Our Commitment to Security
Security and compliance are an ongoing commitment at Astakenis.
We continuously review our processes and practices to maintain strong standards for information security, privacy, and data protection.
For organizations in pharmaceutical manufacturing, biotechnology, medical devices, contract research organizations, and contract development and manufacturing organizations, this commitment provides an important foundation for managing critical quality information.
Trust & Compliance
Certified to protect your quality data
Security and compliance are an ongoing commitment at Astakenis. Our platform and processes are independently audited against global standards. Click any certificate to view it.
Quality Management
ISO 9001
Surveillance Audit
Security
SOC 2 Type II
Security, availability & confidentiality controls
Privacy
GDPR Compliance
EU General Data Protection Regulation
Privacy
HIPAA Compliance
Healthcare data protection