ProQuality Network
Third-party consulting network providing quality, compliance, validation, and technical services to pharmaceutical, biologics, medical device, and related life-science manufacturers. Services focus on regulatory readiness and remediation, validation lifecycle management, technology transfer and scale-up, data integrity and cybersecurity, data analytics and AI/ML for manufacturing operations, and quality risk and project management.
Industries
Nr. of Employees
small (1-50)
ProQuality Network
Sardinera Office Center, C-3 Costa de Oro, Suite 11, Dorado, PR 00646
Products
Compliance and Quality Project Management
Service providing management of compliance and quality projects in life sciences manufacturing to ensure adherence to regulatory standards and internal quality objectives.
Batch Record Review
Review and verification of manufacturing batch records to ensure compliance with cGMP and regulatory requirements in cell and gene therapy environments.
Microbiological Testing and Environmental Monitoring
Laboratory service performing microbiological testing and environmental monitoring to support pharmaceutical manufacturing quality control.
Commissioning and Qualification (C&Q) Services
Execution of commissioning and qualification protocols to validate equipment, utilities, and facilities in pharmaceutical manufacturing.
Quality Assurance Oversight in Manufacturing
On-site quality assurance monitoring during manufacturing to ensure compliance with GMP and company procedures in real-time.
Deviation and CAPA Investigation Services
Conducting root cause analyses and managing investigations of deviations and corrective actions in biopharmaceutical manufacturing.
Compliance and Quality Project Management
Service providing management of compliance and quality projects in life sciences manufacturing to ensure adherence to regulatory standards and internal quality objectives.
Batch Record Review
Review and verification of manufacturing batch records to ensure compliance with cGMP and regulatory requirements in cell and gene therapy environments.
Microbiological Testing and Environmental Monitoring
Laboratory service performing microbiological testing and environmental monitoring to support pharmaceutical manufacturing quality control.
Commissioning and Qualification (C&Q) Services
Execution of commissioning and qualification protocols to validate equipment, utilities, and facilities in pharmaceutical manufacturing.
Quality Assurance Oversight in Manufacturing
On-site quality assurance monitoring during manufacturing to ensure compliance with GMP and company procedures in real-time.
Deviation and CAPA Investigation Services
Conducting root cause analyses and managing investigations of deviations and corrective actions in biopharmaceutical manufacturing.
Services
On-site and virtual third-party/mock audits, regulatory compliance assessments, gap analysis, remediation plan development and execution, and inspection readiness.
Commissioning and qualification of facilities/equipment/utilities, process validation (stages 1-3), cleaning validation, computerized system validation, validation master plans and protocol execution.
Support for product transfers, process characterization, stability/registration runs, process performance qualification and post-approval change support.
Design and implementation of data pipelines, exploratory and predictive analytics, dashboards and visualizations, ML model development and deployment, and integration with enterprise systems (MES, SAP).
QRM planning, facilitation of structured risk tools (FMEA, FMECA, HAZOP, PHA), risk communication, and risk review processes.
Comprehensive data integrity audits, cybersecurity risk assessment for manufacturing systems, recommendations for controls, and alignment with ALCOA+ and Annex 11/21 CFR guidance.
On-site and virtual third-party/mock audits, regulatory compliance assessments, gap analysis, remediation plan development and execution, and inspection readiness.
Commissioning and qualification of facilities/equipment/utilities, process validation (stages 1-3), cleaning validation, computerized system validation, validation master plans and protocol execution.
Support for product transfers, process characterization, stability/registration runs, process performance qualification and post-approval change support.
Design and implementation of data pipelines, exploratory and predictive analytics, dashboards and visualizations, ML model development and deployment, and integration with enterprise systems (MES, SAP).
QRM planning, facilitation of structured risk tools (FMEA, FMECA, HAZOP, PHA), risk communication, and risk review processes.
Comprehensive data integrity audits, cybersecurity risk assessment for manufacturing systems, recommendations for controls, and alignment with ALCOA+ and Annex 11/21 CFR guidance.
Expertise Areas
- Regulatory compliance and inspection readiness
- Validation and lifecycle management (facilities, equipment, process)
- Technology transfer and CMC process scale-up
- Data integrity and cybersecurity for regulated systems
Key Technologies
- Predictive analytics and machine learning
- Data engineering and dashboarding (KPI systems)
- MES and ERP integration
- Electronic batch records (EBR)
News & Updates
Discussion of strategies for digitizing CMC process knowledge, EBR pilots, leveraging enterprise tools and preparing systems for process knowledge retention and transfer.
Overview of cybersecurity risks to pharmaceutical data integrity and recommended controls aligned to FDA and EMA guidance, including ALCOA+ principles and system security measures.
Business case for knowledge management in CMC development, and how structured process knowledge and QRM accelerate regulatory readiness and time-to-market.
Review of regulatory frameworks relevant to AI in manufacturing (FDA draft guidance, GMLP, PCCP, EU AI Act, Annex 11, GAMP 5) and a simplified credibility assessment for AI models.
Site lists aggregated metrics claimed on the website: 20,000+ projects completed; 10,000+ compliance audits and quality-related projects; 5,000+ project management engagements; 4,000+ commissioning & qualification and validation lifecycle events; 500+ clients engaged.
Discussion of strategies for digitizing CMC process knowledge, EBR pilots, leveraging enterprise tools and preparing systems for process knowledge retention and transfer.
Overview of cybersecurity risks to pharmaceutical data integrity and recommended controls aligned to FDA and EMA guidance, including ALCOA+ principles and system security measures.
Business case for knowledge management in CMC development, and how structured process knowledge and QRM accelerate regulatory readiness and time-to-market.
Review of regulatory frameworks relevant to AI in manufacturing (FDA draft guidance, GMLP, PCCP, EU AI Act, Annex 11, GAMP 5) and a simplified credibility assessment for AI models.
Site lists aggregated metrics claimed on the website: 20,000+ projects completed; 10,000+ compliance audits and quality-related projects; 5,000+ project management engagements; 4,000+ commissioning & qualification and validation lifecycle events; 500+ clients engaged.