Trust in Our Quality

Quality and compliance are the foundation of everything we do. It is why our customers trust in Kallik.

Our focus on quality from product design through to customer support ensures that Veraciti™ and your processes are easy to validate, easy to maintain and always underpin patient and consumer safety.

ISO9001:2015 Certified GXP/GAMP Compliant 21CFR Part II/ Annex II Compliant

Trusted Infrastructure

Quality Assurance

Security, Confidentiality and Availability

Kallik maintains a comprehensive security program based on ISO 27001 to ensure the confidentiality, integrity, and availability of customer data. Kallik is committed to ensuring our services are fully available for operation as set forth in service-level agreements, protected against unauthorized physical and logical access and 24/7/365 onsite monitoring.

Full Control

Kallik undergoes rigorous third-party compliance audits of our robust security, confidentiality, and availability controls. Kallik publishes a Service Organization Controls 2 (SOC 2) Type II report under the Security and Availability Trust Service Principles (TSPs). Kallik data centers and service providers also publish SSAE16 SOC1 Type II and SOC3 (SysTrust) reports.

Always GxP/GAMP Compliant

We follow the highest industry standards (GxP/GAMP), quality guidelines and regulations applying the best quality management systems and standard operating procedures (SOPs) to the design, development and delivery of our software.

Global Regulatory Compliance

Veraciti is 21CFR Part 11 compliant, meeting the FDA regulations regarding electronic records and electronic signatures.

Corrective Action/Preventative Action

Kallik leaves nothing to chance. Our Corrective/Preventative Action process quickly identifies any potential non-conformity or issue. With this proactive CAPA approach, we can quickly respond to issues wherever and whenever they might occur.

Continuous Improvement

At Kallik, we understand that quality is never done. We welcome feedback and respond regularly to requests and audits from our client base to ensure that Veraciti continually raises the bar for compliance and quality.

Reliable data

We comprehensively apply FDA ALCOA+ principles to ensure data integrity.

Quality Management System