CompliantCloud.com

Our CompliantCloud.com platform is unique globally in that the entire platform is designed from the ground up to ensure compliance with the global Life Sciences regulatory structures. Our platform is designed from a quality perspective to ensure;

• Full auditability in line with regulatory expectations
  • e.g. Eudralex Chapter 7 requirements for outsourced activity & Annex 11, FDA 21 CFR Part 11
• Our platform provides a fully transparent Quality Management Structure
  • CAPA, NC, Training and infrastructure/application lifecycle management
• Dedicated private cloud hosting
  • Maintain data in jurisdiction
• GDPR compliance

We can deploy cloud hosting based on the specific needs of your business and that, alongside our managed services, makes us uniquely qualified to support Life Sciences implementations.

Our parent company Odyssey VC provides a full suite of services in individual or turnkey configurations based on the needs of our customers. Some of our service capabilites as follows;

• Quality & Compliance Services
  • ISO Standard Implementations e.g. 9001, 27001, 13485
  • Computer Systems Validation
  • Quality Assurance
  • Data Integrity & data flow mapping
  • GDPR
  • IT Compliance
  • Audit support
  • Process audits
• Technical Services
  • Application support
  • Project management and PMO
  • Business analysis
  • Bespoke application design, implementation and management
  • GxP Application implementation
  • Networking and cloud architecture
  • Cyber security

Bespoke and turnkey technology delivery available on request. We assist companies across a number of different TRL phases as follows;

• Activities developed by our organisation across levels 3 to 8 specifically are provided below in examples;
  • TRL 3 – We assist client organisations in the establishment of proof of concept use cases primarily focused on software MVP approaches as we are an X-aaS solutions company
  • TRL 4 – We provide more limited use cases in this area as we are providing technology services to software and Life Sciences focused organisations. That said we do sometimes provide feedback on medical device engineering projects in terms of compliance and device viability for lab based use case verifications
  • TRL 5 – We provide compliance services scaled based on the needs of our client organisations to ensure appropriate controls are in place to facilitate leveraging from this phase of concept development. This would include minimum quality assurance processes and validation/qualification support
  • TRL 6 – This is usually done alongside level 5 and is generally a single use case execution of validation and qualification exercises as they refer to compliance X-aaS use cases
  • TRL 7 – This is usually done alongside level 5 also as the software is generally designed, built and tested in the target commercial use cases considering they are an X-aaS deployment model
  • TRL 8 – This is the majority of our workload as we provide full end to end project delivery from TRL 1 to 8 and support our customers in the case of monitoring performance for TRL 9.

Compliance-as-a-Service
Qualified-IaaS