Advasur Quality and Validation
Our cost-effective range of validation, qualification, and testing solutions help you improve your systems and processes to reduce variability, mitigate the risk of non-compliance and ensure reliability.
Whatever FDA product jurisdictional business sector you operate in, our experienced subject matter experts use proven processes and industry best practices to help you comply with all necessary regulations and drive value across your supply chain.
Computer System Validation (CSV) and CSV Programming Validation:
- Enterprise Resource
- Planning (ERP).
- Electronic Product
- Code Information
- Service (EPCIS).
- Quality Management
- Systems (QMS).
- Process and Method validation.
- Sterilization validation.
- Cleaning validation.
- Facilities and Utilities qualification.
- Temperature and environmental monitoring.
- Equipment qualification.
- Factory and site acceptance testing.
- Risk assessment and risk mitigation.
- Risk assessment and risk mitigation.
- Validation and compliance training.
- Electronic Document
- Management Systems (EDMS).
- Corrective Action and Preventive Action (CAPA).
- Learning Management Systems (LMS).
- Manufacturing Execution Systems (MES).
- Laboratory Information Management Systems (LIMS).
- IT infrastructure and security.
- Data integrity assessment and Data integrity issues resolution plans.
Quality Management
We offer a range of quality management services to ensure
your systems are optimized and compliant from the very
beginning of your journey towards commercialization.
This helps mitigate your risk of experiencing costly and/or
time-consuming non-compliant situations when going to
market, while at the same time driving process reliability
and repeatability. From Strategy through Sustainability,
our subject matter experts can also provide ongoing
guidance and support around how your systems should
be validated and maintained in order to comply with new
or evolving legislation.
- Quality Tabletop Audit and Quality Issues Simulation
- Analytic Testing Tools
- Quality Systems Implementation Plan
- FDA Product Jurisdictional
- Compliance Assessment and Auditing
- Quality Gap Analysis
- Federal and State Government Inspection Readiness
- Internal, Supply Chain ATP business partners and Independent Audit Support
- Remediation Plan and Execution
