SynerQ
Consultancy focused on quality, compliance, and validation for the pharmaceutical and medical device industries. Services include auditing and gap analysis against regulatory guidance, commissioning and qualification of facilities and systems, validation project planning and execution (IQ/OQ/PQ), controls and automated systems validation including 21 CFR Part 11 assessments, and process improvement using statistical and risk-based methods.
Industries
Nr. of Employees
small (1-50)
Products
Compliance Services
We provide personnel to develop and execute the required documentation to achieve full compliance of your GMP manufacturing facilities and systems.
Auditing Services
We audit your facility or systems and identify gaps against current guidance and regulation and present solutions quickly and systematically.
Commissioning and Qualification
We assist with the onsite qualification of critical systems such as critical utilities, cleanrooms, process equipment, and sterilization systems.
Development of Project Strategy
We develop project strategies that include team synergy, integration, project change management, and resource management to ensure successful project execution.
Automated Systems
We work with suppliers to develop user requirements and system specifications for new automated systems and create remediation plans for legacy systems.
Compliance Services
We provide personnel to develop and execute the required documentation to achieve full compliance of your GMP manufacturing facilities and systems.
Auditing Services
We audit your facility or systems and identify gaps against current guidance and regulation and present solutions quickly and systematically.
Commissioning and Qualification
We assist with the onsite qualification of critical systems such as critical utilities, cleanrooms, process equipment, and sterilization systems.
Development of Project Strategy
We develop project strategies that include team synergy, integration, project change management, and resource management to ensure successful project execution.
Automated Systems
We work with suppliers to develop user requirements and system specifications for new automated systems and create remediation plans for legacy systems.
Services
Personnel and services to develop and execute documentation and testing required for GMP compliance, commissioning, system qualification, process validation, and operations support.
Facility and system audits to identify regulatory gaps, risk-focused evaluations, and development of remediation plans; provision of experienced auditors (including ASQ-certified auditors).
Personnel and services to develop and execute documentation and testing required for GMP compliance, commissioning, system qualification, process validation, and operations support.
Facility and system audits to identify regulatory gaps, risk-focused evaluations, and development of remediation plans; provision of experienced auditors (including ASQ-certified auditors).
Expertise Areas
- Regulatory compliance and quality assurance
- Validation and commissioning of manufacturing systems
- Auditing and gap analysis for pharmaceutical and medical device systems
- Automated systems and control system qualification
Key Technologies
- IQ/OQ/PQ qualification protocols
- Automated control and information systems validation
- Electronic records and electronic signature validation (21 CFR Part 11)
- Statistical process capability analysis
News & Updates
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Featured article (placeholder content) discussing aspects of compliance approach and related topics.
Featured article (placeholder content).