“Complying with the international standards and globally recognized best practices for product development, quality management, information security, and internal operations is an integral part of the Calibo ethos. We are committed to maintaining integrity, ensuring transparency, and delivering a superlative customer experience.”
Shubho Mohanty
Chief Product Officer, Calibo Inc.
GxP compliance
The Calibo platform underwent a thorough evaluation of its technical and procedural controls to ensure alignment with the stringent standards of GxP regulations. This review was meticulously guided by the regulatory specifications outlined in:
- 21 CFR Part 11 Subpart B, which defines the U.S. FDA’s regulations on electronic records.
- EU Annex 11, detailing the European Union’s regulatory requirements.
KPMG performed an in-depth gap analysis to identify areas for enhancement and subsequently presented a report outlining recommended corrective actions. The Calibo team diligently addressed and implemented these suggestions, all of which were subject to successful validation by KPMG.
The Calibo platform fully aligns with the GxP-related controls as delineated by the regulatory standards and guidelines previously mentioned.
ISO 9001:2015
The ISO 9001:2015 certification is a testimony to Calibo’s strategic focus on quality management system with an aim to improve our overall performance as a part of our sustainable development initiatives.
The certification underlines:
- Our ability to consistently provide products and services that meet customer expectations and applicable statutory and regulatory requirements
- Our commitment to enhancing customer satisfaction through the effective application of the system
- Our adherence to the quality management principles: Customer Focus, Leadership, Engagement of People, Process Approach, Improvement, Evidence-Based Decision Making, Relationship Management
Calibo Inc. has become an ISO 9001:2015 certified organization after successful completion of a rigorous audit from a third-party certification body. The following activities in Calibo Inc. have been audited for this certification:
- Product Management
- Product Development
- Quality Engineering
- SaaS Operations
- Infrastructure & IT services
- Human Resources
- Finance
- Procurement & Legal
- Product Marketing
- Customer Support
The certificate is available here.
ISO/IEC 27001:2013
The ISO/IEC 27001:2013 certification is a proof that we have the required security management best practices and controls in place. It ensures that we have established, implemented, maintained, and are continually improving an information security management system (ISMS) within Calibo Inc.
The certification also proves that we meet the requirements for the assessment and treatment of information security keeping our information assets (both IT and non-IT) secure amidst the ever-changing cyber security threat landscape and risks.
Calibo Inc. has become an ISO/IEC 27001:2013 certified organization after successful completion of a rigorous audit from a third-party certification body. The following activities in Calibo Inc. have been audited for this certification:
- Product Management
- Product Development
- Quality Engineering
- SaaS Operations
- Infrastructure & IT services
- Human Resources
- Customer Support
The certificate is available here.
ISO/IEC 27017:2015
The ISO/IEC 27017:2015 certification proves that we follow all the recommended guidelines for information security controls applicable to providing cloud service offerings.
Calibo Inc. has become an ISO/IEC 27017:2015 certified organization after successful completion of a rigorous audit from a third-party certification body. The following activities in Calibo Inc. have been audited for this certification:
- Product Management
- Product Development
- Quality Engineering
- SaaS Operations
- Infrastructure & IT services
- Human Resources
- Customer Support
The certificate is available here.