Quality Excellence, LLC
Services
Our services are delivered in English or Spanish.
Our customers range from the healthcare, manufacturing of biopharmaceutical, foods, cosmetics, and compounding pharmacy areas.
Our evidence and research-based diagnostics tools take our customers to deep dive into the drivers of their organizational culture. We work together to align their culture to their business strategy and design a monitoring system that gives indication of the success of their business strategy.
We provide consulting services for compliance with regulatory requirements, inspection readiness, quality risk management, optimization of quality systems and metrics, quality systems maturity assessments, regulatory training, and organizational/technical capability to all levels of the organization. We prepare firms for inspections through mock audits, regulatory training, regulatory intelligence, and support before, during and after audits from global regulatory agencies.
We collaborate with our customers to align the human systems to support the organizational culture and strategy anchored in the vision, mission, and values of the firm. We help our customers to define the roles and responsibilities required to execute their strategic objectives and develop learning plans and metrics that help them to track their progress. We work with our customer’s human force to gather, organize, and analyze its tacit knowledge into operational documents easily accessible to employees to preserve formal and informal knowledge of the organization during times of transition and to accelerate onboarding of new resources.
Our customers range from the healthcare, manufacturing of biopharmaceutical, foods, cosmetics, and compounding pharmacy areas.
Our evidence and research-based diagnostics tools take our customers to deep dive into the drivers of their organizational culture. We work together to align their culture to their business strategy and design a monitoring system that gives indication of the success of their business strategy.
We provide consulting services for compliance with regulatory requirements, inspection readiness, quality risk management, optimization of quality systems and metrics, quality systems maturity assessments, regulatory training, and organizational/technical capability to all levels of the organization. We prepare firms for inspections through mock audits, regulatory training, regulatory intelligence, and support before, during and after audits from global regulatory agencies.
We collaborate with our customers to align the human systems to support the organizational culture and strategy anchored in the vision, mission, and values of the firm. We help our customers to define the roles and responsibilities required to execute their strategic objectives and develop learning plans and metrics that help them to track their progress. We work with our customer’s human force to gather, organize, and analyze its tacit knowledge into operational documents easily accessible to employees to preserve formal and informal knowledge of the organization during times of transition and to accelerate onboarding of new resources.
Service 1
Organizational Culture Transformation
- Organizational Culture Assessment through research-based tools
- Organizational Culture Alignment to Business Strategy through evidence-based methodologies
- Vision, Mission, Objectives and Strategies Development and Deployment
- Metrics / Business Results Gap Assessment and Improvement Action Plans
Service 2
Quality Systems
We assess your quality systems against global regulations and guidance to ensure compliance. We design inspection proof systems, procedures, metrics, and training on:
- Quality Risk Management
- Investigations and CAPA System
- Complaints System
- Change Management System
- Internal Audit Program
- Documentation System
- Of utmost importance is the advancement of the maturity level of your Quality Systems
- We perform objective assessments of the maturity levels of your quality systems to demonstrate a robust quality culture with proven tools that indicate exactly where you are in your journey to impulse your compliance levels.
- We collaborate with your firm to optimize your quality systems as the backbone of an effective and compliant product lifecycle.
Service 3
Human Systems
- Employee Manuals
- Roles and Responsibilities alignment to business strategy
- Procedure assessment to reduce Human Error
- Human Error Analysis and development of preventive actions
- Competencies Assessments, Gaps Identification and Capabilities Improvement Plan
- Training curricula design, optimization, and metrics system
- Organizational Excellence Learning Programs
Service 4
Maturity Assessment of Quality Systems
• We perform objective assessments of the maturity of your quality systems to demonstrate a robust quality culture.
• We collaborate with your firm to optimize your quality system as the backbone of an effective and compliant product lifecycle.Gap Assessments, Remediation and Mitigation Plans
• We tackle opportunities in organizational and quality regulatory compliance and work with your human resources and quality colleagues to develop plans to correct, prevent and mitigate regulatory risk.
• We collaborate with your firm to optimize your quality system as the backbone of an effective and compliant product lifecycle.Gap Assessments, Remediation and Mitigation Plans
• We tackle opportunities in organizational and quality regulatory compliance and work with your human resources and quality colleagues to develop plans to correct, prevent and mitigate regulatory risk.
Service 5
Knowledge and Learning Systems
- Identify and preserve technical and business knowledge into permanent repositories.
- Identify at risk knowledge due to restructuring, joint ventures, M&A, divestitures, new companies, contract manufacturers, product or technology transfer.
- Incorporate critical knowledge into training plans.
- Align roles and responsibilities to job descriptions across all levels of the organization
- Learning gap assessments and action plans
- Learning Plans optimization
- Development of Learning Programs (business, organizational development, regulatory or quality systems)
Service 6
Regulatory Compliance Assessments
- In preparation for regulatory audits or product approvals, we conduct regulatory assessments on quality systems, product, personnel, documents to ensure successful audit outcomes.
- We develop remediation and mitigation plans to address improvement opportunities to enhance your firm’s compliance level
- We tackle opportunities in organizational, quality and regulatory compliance and work with your human resources and quality colleagues to develop plans to correct, prevent and mitigate regulatory risk.
- Regulatory consulting in FDA, EU, PIC/s and International GMP Regulations for supplier management, biopharmaceutical manufacturing, distribution, compounding/pharmacies and healthcare providers
Service 7
Product Registration
- Agent to register biopharmaceutical products and non-prescription drugs in Puerto Rico Commonwealth
Service 7
Inspection Readiness
- Our inspection readiness model includes regulatory training, walkthroughs, mock audits, logistics, documents review, and onsite or virtual support before, during and after the inspection.
- We conduct behavioral training and what to do/what not to do during inspections
- We help you implement logistics, support systems and readiness for virtual and onsite global regulatory inspections