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SERVICES
We serve as your external consulting partner for compliance readiness and remediation endeavors.
We offer top-tier consultants, quality experts, and advisors, all deeply committed to addressing your quality-centric challenges.
Our regulatory compliance services include on-site and virtual third-party and mock audits, compliance assessments, remediation plans development, site inspection readiness and enhancement plans, third-party oversight, data integrity and DIRA, quality culture and sustainability of compliance, quality communications plan design, investigations backlog resolution, CAPA effectiveness, root cause analysis, SOP simplification, records management and document controls, storyboard creation and improvement, and quality systems enhancement.
• Start Up of Facilities
• C&Q: Facilities, Equipment, Utilities
• Process Validation: Stages 1 - 3
• Continuous Process Verification (CPV)
• Cleaning Validation
• Computer Systems Validation
• Capacity Expansion: C&Q & Validation
• Systems Development Lifecycle
Management (SDLC):
• Seven Stages: Requirements & Analysis, Project Planning, Design, Coding & Implementation, Testing ,Deployment, Maintenance.
• URS, DS,
• FAT, SAT
• Traceability Metric (TM)
• Validation Master Plans
• Validation Protocols
• Validation Protocols Execution
• Validation Reports
We offer comprehensive project management services, including PMO services, project plans and management tools, progress metrics, reporting and dashboards, risk evaluation and mitigation, milestones and resource loading, change management processes, and project budgeting.
• Risk Management Tools
• QRM Plans
• DIRA’s
• Risk Assessments
• Risk Mitigation
• Risk Control
• Risk Communication
• Risk Review
• Facilitation Methods:
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects and Criticality Analysis (FMECA
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk Ranking and Filtering
• Compliance with ALCOA and ALCOA+ elements.
• DIRA (Data Integrity Risk Assessments)
• Data Integrity Audits: Comprehensive audits of data systems, processes, and practices to identify vulnerabilities and non-compliance issues.
• Gap Analysis and Risk Assessment: Assessing current data management practices to identify gaps and potential risks to data integrity.
• Periodic Reviews and Reconciliation: Conducting periodic reviews of data to ensure consistency, accuracy, and compliance.
• Continuous Improvement Initiatives: Establishing programs to continuously improve data integrity practices and adapt to evolving regulations.
• Regulatory Compliance Assistance: Providing guidance and support to meet regulatory requirements related to data integrity.
We provide comprehensive support for technology transfer, including startup product transfer support, tech transfer strategy, process development, characterization, engineering studies, stability runs, registration runs, product and method transfer support, process performance qualification, process validation, regulatory agency changes filing and registration, and scale-up and post-approval changes (SUPAC).
• Data Engineering & Visualization
• Descriptive, diagnostic, predictive, and prescriptive analytics
• Design, development, deployment, and maintenance of strategic, operational and analytic dashboards
• Root cause analysis, confounding variables, model
cause-effect relationships
• Data analytics, data mining, statistical analysis: Historical
and actual data
We offer a range of services under Knowledge & Talent Management, including training and mentoring, skill enhancement, coaching, and contingent talent sourcing.
• Sate of Good Repair Mitigation Plan
• Asset Identification and Prioritization
• Asset Management Strategy Optimization
• Failure Analysis and FMEA
• Key Performance Indicators (KPIs)
• Lagging KPIs Measurement and Trending
• Action Plan Development
• Effectiveness Evaluation
• Periodic Reviews and Continuous Improvement
• Quality Audits to assess compliance state with regulatory requirements.
• Professional evaluation of Quality Systems robustness
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