WHY CHOOSE COMPLIANCE GROUP?
Digital transformation made easy with a partner that collaborates directly with the FDA and other regulatory bodies to help clarify misperceptions and shape the regulatory landscape
For superior digital transformation, selecting the right partner is crucial, and here's what makes Compliance Group a unique, differentiated and value-added Siemens Partner. CG began as a validation partner for Siemens Digital Industries, mastering applications like Teamcenter, Opcenter MES, Polarion, Mendix, and more. Our CSA methodology has been successfully applied across these platforms, showcasing our comprehensive understanding of their intended uses, risk assessments, and test assurance plans. As co-facilitators of FDA workshops on “Digital Thread Validation” and “Digital Agile CSA for low-code,” CG is uniquely positioned as a leading validation expert.
The key objective of digital transformation is Organizational Success not merely Implementation Success. CG's Organizational Change Management (OCM) uses a unique methodology agnostic approach. CG leverages the Actualization Change Model™, developed by Dr. Jeffery G. Soper, to adapt strategies, plans, training, and communications to the specific needs and objectives of organizations, ensuring that changes are not just implemented but co-created with stakeholders for contextual relevance and ownership.
Through the OCM approach, CG focuses on building organizational capacity through collaborative learning and coaching, emphasizing the importance of mindset in successful change adoption. The approach includes phases such as Acknowledgment, Adaption, Adoption, and Actualization, which help organizations achieve and sustain digital transformation aligned with long-term strategic goals.
Polarion
Together, Polarion ALM and Compliance Group empower life science organizations to achieve:
- Faster development cycles for compliant products
- Reduced risk of non-compliance issues
- Lower overall costs
- Higher quality products that reach patients faster
Mendix
Compliance Group and Mendix: Your trusted partners for achieving faster, more compliant life sciences innovation.
- Build compliant applications faster
- Simplify compliance integration
- Empower citizen developers
- Maintain audit trails effortlessly
IMPLEMENTING CENTERS OF EXCELLENCE WITH COMPLIANCE GROUP
Supercharge your ALM with Polarion and Compliance Group
- Accelerated Development & Enhanced Product Quality: Deliver compliant products faster and bring higher quality products to market more swiftly.
- Minimized Compliance Risks & Cost Efficiency: Reduce the risk of non-compliance issues while lowering overall operational costs.
- Effortless Setup & Expertise: Deploy Polarion in your cloud, optimize workflows, and provide custom development to enhance its capabilities.
- Streamlined & Secure Operations: Establish CI/CD pipelines, monitor systems, and enforce governance for smooth, secure operations.
- Seamless Integrations: Connect Polarion to your existing tools (JIRA, ServiceNow, etc.) for maximum collaboration.
- Expert Data Migration & User Adoption: Seamlessly migrate your data and ensure a smooth transition for your users.
- Unmatched Validation: Manage the entire validation lifecycle, crucial for regulated industries.
- Centralized Microlearning: CG’s microlearning offers self-paced, consistent access to knowledge, enhancing performance through continuous, monitored learning.
- Impact-Aligned Learning: CG’s microlearning aligns learning objectives with organizational impact, ensuring digital transformation leads to measurable, meaningful outcomes.
Build Aps Faster, and Better with Mendix and Compliance Group
- Rapid Application Development: Quickly build compliant applications.
- Simplified Compliance and Integration: Ensure seamless compliance integration.
- Empowered Development: Enable non-technical users to create applications.
- Effortless Audit Trails: Maintain comprehensive audit trails with ease.
- Efficient App Deployment and Security: Deploy Mendix in your private cloud, optimize app stores, and enforce governance for secure operations.
- Streamlined Development Practices: Establish CI/CD pipelines, monitoring, and integrate DevOps practices for efficient collaboration.
- Seamless Integrations: Connect Mendix apps to existing tools for a unified development experience.
- Expert Data Migration and User Adoption: Seamlessly migrate data and ensure a smooth transition for your development teams.
- Validation Lifecycle Management: Manage the validation lifecycle, crucial for regulated industries.
ON-DEMAND RESOURCING WITH COMPLIANCE GROUP
Assemble Your Team with Confidence!
- Immediate & Flexible Staffing: Get specialized skill sets when and where you need them with our adaptable team extensions.
- Expert Team: Professionals with over 5 years of FDA-regulated experience ensure compliance and quality.
- Minimal Training Required: Quick integration with only site-specific training and minimal oversight needed.
- Efficiency Gains: Reduce risks, speed up processes, and free up internal resources with our experienced team.
- Full Siemens Portfolio Staffing: Experience and capability across the entire Siemens DI Software solutions
- Managed Services for Validation Staffing.
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