Quality Consulting Services

Biotech and pharma industries are highly regulated nowadays, and maintaining rigorous quality standards is not just a necessity but a critical differentiator. One of the most significant pain points for companies is ensuring that their quality systems are robust, compliant, and efficient while adapting to ever-evolving regulatory requirements. At Viltis Consulting, we offer comprehensive Quality Consulting Services to help you build and sustain the highest levels of quality across your operations. Our expertise covers quality systems design, regulatory compliance, validation, auditing, and continuous improvement, ensuring your products meet the strictest standards and exceed customer expectations.

Quality Systems

Companies usually struggle with designing and implementing quality systems that not only comply with regulatory standards but also drive continuous improvement and operational efficiency. Viltis’ experts help you overcome this challenge by offering tailored solutions for quality systems that align with both your business needs and regulatory demands.

• Quality Systems Design, Strategy, and Implementation: Creating comprehensive quality systems that ensure compliance and support operational excellence.
• Quality Management Systems (QMS) Development: Developing and refining QMS to promote continuous improvement and ensure compliance with industry standards.
• Quality Assurance (QA): Implementing systematic processes and audits to ensure that products consistently meet high-quality standards.
• Quality Control (QC): Establishing robust monitoring and testing protocols to ensure product integrity and safety.

Regulatory Compliance

The risk of non-compliance can lead to delays, financial penalties, and reputational damage. We provide expert guidance to help you navigate the regulatory landscape, ensuring that your operations meet all necessary standards and that your regulatory submissions are successful.

• Compliance Audits: Conducting thorough audits to ensure your processes and products comply with regulatory standards such as FDA, EMA, etc.
• Regulatory Strategy and Submissions: Developing effective strategies for regulatory submissions and managing interactions with regulatory bodies.
• Data Integrity Compliance (21 CFR Part 11): Ensuring that electronic records and signatures are secure, reliable, and compliant.
• Regulatory Affairs: Managing all aspects of regulatory submissions, approvals, and ongoing compliance to keep your operations aligned with regulations.

Validation Services

Validation is a critical aspect of making sure that your manufacturing processes, equipment, and systems consistently produce high-quality products. The complexity of validation, coupled with stringent regulatory expectations, can be a major pain point for companies. Viltis provides comprehensive validation services for your operations to meet the highest standards of quality and regulatory compliance.

• Process Validation: Ensuring that manufacturing processes produce consistent, high-quality outcomes.
• Equipment Validation: Verifying that all equipment performs as intended and meets regulatory standards.
• Cleaning Validation: Confirming that cleaning procedures effectively remove contaminants and residues.
• Computer System Validation (CSV): Ensuring that your software and systems maintain data integrity and comply with regulatory requirements.

Auditing and Inspection Management

Viltis provides its experts to prepare you for critical events of auditing and inspection by conducting internal and supplier audits, managing inspection readiness, and implementing corrective actions.

• Internal Audits: Identifying and addressing potential compliance issues before they become problems.
• Supplier Audits: Ensuring the quality and compliance of materials and services provided by suppliers.
• Inspection Readiness: Preparing for regulatory inspections to ensure your operations pass with flying colors.
• Corrective and Preventive Actions (CAPA): Developing and implementing plans to correct non-compliances and prevent their recurrence.

Training and Development

Maintaining high-quality standards is ensuring that your staff is fully trained and up-to-date with the latest industry practices and regulatory requirements. Viltis Consulting provides comprehensive training programs designed to equip your team with the knowledge and skills they need to uphold quality and compliance in all aspects of their work.

• Quality and Compliance Training: Offering training programs to ensure your staff is well-versed in current quality and compliance standards.
• Employee Development Programs: Creating ongoing development plans to keep your team informed and proficient in industry best practices.

Documentation and Record Management

Managing documentation and maintaining records in a compliant manner can be a complex and time-consuming process. Viltis Consulting helps you implement and manage efficient documentation practices that ensure accuracy, compliance, and easy access to critical records.

• Good Documentation Practices (GDP): Implementing high standards for documentation to ensure accuracy and regulatory compliance.
• Batch Record Review: Reviewing production records to ensure completeness, accuracy, and compliance.
• Document Control: Managing and controlling access to quality-related documents to maintain security and compliance.

Risk Management

We offer comprehensive risk management services, including risk assessments and failure mode analysis, to help you identify potential issues and implement strategies to mitigate them.

• Risk Assessments: Identifying and mitigating risks associated with manufacturing and quality processes.
• Failure Mode and Effects Analysis (FMEA): Analyzing potential failure points and their impact on product quality.
• Hazard Analysis and Critical Control Points (HACCP): Implementing HACCP principles to manage and control potential hazards.

Continuous Improvement

Viltis helps you apply lean manufacturing and Six Sigma methodologies to optimize your processes, improve quality, and enhance overall operational excellence.

• Lean Manufacturing and Six Sigma: Applying lean and Six Sigma methodologies to improve quality and efficiency.
• Performance Metrics and Monitoring: Developing and tracking key performance indicators (KPIs) to monitor and improve quality processes.
• Quality Improvement Initiatives: Leading initiatives to enhance overall quality and operational excellence.

Pharmaceutical Industry Roles

Quality Assurance (QA) Roles

• Quality Assurance Manager
• Quality Assurance Specialist
• Quality Assurance Inspector
• Senior Quality Assurance Engineer
• Quality Assurance Technician
• Quality Assurance Analyst
• Quality Assurance Director
• Quality Assurance Associate

Quality Control (QC) Roles

• Quality Control Manager
• Quality Control Analyst
• Quality Control Technician
• Senior Quality Control Specialist
• Quality Control Inspector
• Quality Control Associate
• Quality Control Chemist
• Quality Control Microbiologist

Quality Systems Roles

• Quality Systems Manager
• Quality Systems Specialist
• Quality Systems Engineer
• Quality Systems Coordinator
• Quality Systems Analyst

Validation Roles

• Validation Manager
• Validation Specialist
• Validation Engineer
• Senior Validation Scientist
• Validation Coordinator
• Validation Technician
• Computer System Validation (CSV) Specialist

Auditing and Compliance Roles

• Quality Compliance Manager
• Quality Auditor
• Compliance Specialist
• Internal Auditor
• Supplier Quality Auditor
• Regulatory Compliance Manager

Documentation and Record Management Roles

• Documentation Specialist
• Document Control Manager
• Document Control Specialist
• Records Management Specialist
• Batch Record Reviewer

Training and Development Roles

• Quality Training Manager
• Training Coordinator
• Compliance Training Specialist
• Employee Development Specialist

Risk Management Roles

• Risk Manager
• Risk Assessment Specialist
• Quality Risk Manager
• FMEA Specialist

Continuous Improvement Roles

• Continuous Improvement Manager
• Lean Six Sigma Specialist
• Quality Improvement Coordinator
• Performance Improvement Analyst

Data Integrity Roles

• Data Integrity Manager
• Data Integrity Specialist
• Data Integrity Analyst

Medical Device Industry

Quality Assurance (QA) Roles

• Quality Assurance Manager
• Quality Assurance Specialist
• Quality Assurance Inspector
• Senior Quality Assurance Engineer
• Quality Assurance Technician
• Quality Assurance Analyst
• Quality Assurance Director
• Quality Assurance Associate
• Quality Assurance Engineer

Quality Control (QC) Roles

• Quality Control Manager
• Quality Control Analyst
• Quality Control Technician
• Senior Quality Control Specialist
• Quality Control Inspector
• Quality Control Associate
• Quality Control Chemist
• Quality Control Microbiologist

Quality Systems Roles

• Quality Systems Manager
• Quality Systems Specialist
• Quality Systems Engineer
• Quality Systems Coordinator
• Quality Systems Analyst

Validation Roles

• Validation Manager
• Validation Specialist
• Validation Engineer
• Senior Validation Scientist
• Validation Coordinator
• Validation Technician
• Computer System Validation (CSV) Specialist

Auditing and Compliance Roles

• Quality Compliance Manager
• Quality Auditor
• Compliance Specialist
• Internal Auditor
• Supplier Quality Auditor
• Regulatory Compliance Manager

Documentation and Record Management Roles

• Documentation Specialist
• Document Control Manager
• Document Control Specialist
• Records Management Specialist
• Batch Record Reviewer

Training and Development Roles

• Quality Training Manager
• Training Coordinator
• Compliance Training Specialist
• Employee Development Specialist

Risk Management Roles

• Risk Manager
• Risk Assessment Specialist
• Quality Risk Manager
• FMEA Specialist

Continuous Improvement Roles

• Continuous Improvement Manager
• Lean Six Sigma Specialist
• Quality Improvement Coordinator
• Performance Improvement Analyst

Data Integrity Roles

• Data Integrity Manager
• Data Integrity Specialist
• Data Integrity Analyst

Biologics Industry

Quality Assurance (QA) Roles

• Quality Assurance Manager
• Quality Assurance Specialist
• Quality Assurance Inspector
• Senior Quality Assurance Engineer
• Quality Assurance Technician
• Quality Assurance Analyst
• Quality Assurance Director
• Quality Assurance Associate

Quality Control (QC) Roles

• Quality Control Manager
• Quality Control Analyst
• Quality Control Technician
• Senior Quality Control Specialist
• Quality Control Inspector
• Quality Control Associate
• Quality Control Chemist
• Quality Control Microbiologist

Quality Systems Roles

• Quality Systems Manager
• Quality Systems Specialist
• Quality Systems Engineer
• Quality Systems Coordinator
• Quality Systems Analyst

Validation Roles

• Validation Manager
• Validation Specialist
• Validation Engineer
• Senior Validation Scientist
• Validation Coordinator
• Validation Technician
• Computer System Validation (CSV) Specialist

Auditing and Compliance Roles

• Quality Compliance Manager
• Quality Auditor
• Compliance Specialist
• Internal Auditor
• Supplier Quality Auditor
• Regulatory Compliance Manager

Documentation and Record Management Roles

• Documentation Specialist
• Document Control Manager
• Document Control Specialist
• Records Management Specialist
• Batch Record Reviewer

Training and Development Roles

• Quality Training Manager
• Training Coordinator
• Compliance Training Specialist
• Employee Development Specialist

Risk Management Roles

• Risk Manager
• Risk Assessment Specialist
• Quality Risk Manager
• FMEA Specialist

Continuous Improvement Roles

• Continuous Improvement Manager
• Lean Six Sigma Specialist
• Quality Improvement Coordinator
• Performance Improvement Analyst

Data Integrity Roles

• Data Integrity Manager
• Data Integrity Specialist
• Data Integrity Analyst