Trusted by Leading Regulated Industry Organizations
Life Sciences organizations rely on Dokeos Compliance Consulting along 5 core objectives
Dokeos Consulting has been helping Life Sciences companies for 12 years to generate full traceability, comply with up-to-date regulations, improve quality, and streamline operations. Avoid delays and regulatory risks!
1. CAPA Optimization and Continuous Improvement
Shift to a proactive CAPA system that shrinks corrective actions scope and strengthens Quality Assurance.
2. Software Validation and Integration
Connect the Training process to your Quality Management System.
3. Medical Devices Organizations Compliance
Address FDA ISO 13485 regulation with tailored code and data rationale for audits, documentation, and training.
4. GxP Training Course Material
Off the shelf G(x)P and cG(x)P course material. 100% training material encompassing Good Laboratory, Clinical, Documentation, Manufacturing, Logistics and Packaging Practice, Pharmacovigilance, Food, Cosmetics.
5. Master Quality with Expert Guidance
Rely on our seasoned consulting team to optimize your Quality and Compliance processes.
We specialize in providing tailored solutions for the Life Science Industry, ensuring compliance, efficiency and innovation.
1. CAPA Optimization and Continuous Improvement
Transition to a fully preventive action-oriented CAPA system.
- Expert-led root cause analysis workshops.
- Custom CAPA framework strategy.
- Training and real-time support for CAPA implementation.
Dokeos CAPA services aim at containing the volume of corrective actions, thereby strengthening your overall quality management system and reducing the likelihood of regulatory scrutiny, as long as increasing overall productivity.
Dokeos' Value Proposition
By leveraging its expertise in regulatory affairs and quality assurance, Dokeos helps minimizing audit exposure and enhancing processes reliability. Our approach emphasizes not only corrective measures but a shift towards preventive actions, aligning your operations with best practices that meet stringent FDA and EMA standards.
2. Software Validation and Integration
Ensure smooth and compliant integration of a new software system.
- Software Requirements Gathering Guide (SRGG): no time wasted, follow the guide
- Step-by-step support through the CSV process including CSV templating and planning.
- Validation of critical software components, including user interfaces, data management, quality manual and security protocols.
Proper validation not only ensures compliance but also enhances operational efficiency by eliminating unnecessary features and focusing on what truly matters for regulatory compliance
Dokeos' Value Proposition
Dokeos provides a tailored approach to Computerized System Validation (CSV) so as to unfold software features thoroughly, vetted and validated according to your specific operational needs. Our services are designed to streamline the validation process, integrating quality and compliance into every stage of the software lifecycle.
3. Medical Devices Compliance
Achieve compliance with FDA ISO 13485 standards.
- Pre-audit preparation and compliance support.
- Documentation and regulatory submission assistance.
- Tailored training programs on ISO 13485 and FDA requirements.
- 360 degrees compliance including device, app, code, data and server versioning and check.
Ensuring compliance with medical device regulations is critical for market entry and avoiding costly penalties. Dokeos provides the necessary expertise to streamline this process, making compliance more manageable and less burdensome.
Dokeos' Value Proposition
With increasing regulatory scrutiny on medical devices, Dokeos’s consulting services are designed to help you navigate the complexities of FDA and ISO standards. Our approach provides you with the tools and expertise necessary to ensure your devices meet regulatory requirements.
4. GxP Training Course Material
Develop a compliant and effective training program tailored to your organization.
- Development of custom courses based on your set of SOPs and industry regulations.
- Integration of advanced learning technologies, including VR simulations.
- Comprehensive reporting and certification to demonstrate compliance.
- Global market readiness : FDA, EMA, ICH and WHO regulatory bodies.
Effective training is essential for maintaining compliance across all levels of your organization and adressing the market worldwide. Our training programs ensure that your staff is fully equipped to meet regulatory requirements, thereby reducing risks during audits and inspections and accelerating market allowance.
Dokeos' Value Proposition
Dokeos offers custom GxP training programs tailored to your specific operational and regulatory needs. Our training solution is designed to be both engaging and effective, ensuring that your team is always audit-ready.
5. Master Quality with Expert Guidance
Define and implement a strategic digital learning framework. Along your site masterfile, deploy your policies so as to adress each SOP to the adequate job description or teams
- Assessment of current learning strategies and identification of gaps.
- Development of a custom digital learning roadmap.
- Ongoing optimization and support to ensure continuous improvement.
A well-crafted digital learning strategy can significantly enhance training effectiveness, regulatory compliance, and overall employee engagement. Dokeos’s consulting services ensure that your digital learning initiatives are aligned with your longterm business goals and integrate with third party systems.
Dokeos' Value Proposition
Dokeos helps you design a digital learning strategy that aligns with your business objectives and regulatory requirements. We ensure that your digital learning initiatives are both strategic and impactful.
Our Proven Process for Compliance Success
Dokeos helps you streamline Computerized System Validation through a methodology based on Software Requirements Gathering.
Needs Analysis
Gather your goals and compliance requirements.
Custom Validation Plan
Unfold a strategy tailored to your systems and processes.
Implementation and Training
Ensure your team is fully equipped to operate within compliance standards.
Continuous Validation
Guarantee ongoing versioning, updates and requirements monitoring.
Partner with our compliance experts
Dokeos’ experts deliver tailored strategies to ensure regulatory alignment and audit readiness.
Still have questions?
A Validated Training Management System
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