QA Solns
QA Solns is a niche Contract Research Organization (CRO) specializing in developing and maintaining quality systems required by FDA and EU regulations. With over 20 years of experience, they serve small and start-up biotech/pharma companies worldwide, offering tailored services including audits, vendor oversight, documentation, and validation to meet compliance needs from bench-top to market.
Industries
Nr. of Employees
small (1-50)
Services
On-site and remote vendor and subcontractor audits to assess compliance and quality of outsourced functions.
Oversight plans and ongoing oversight of outsourced manufacturing and clinical operations to demonstrate sponsor responsibilities are met.
Conducting Good Clinical Practice site audits to assess trial conduct, subject protection, and data integrity.
Development of quality manuals, SOPs, and documentation aligned to business plans and regulatory milestones.
Validation of software and infrastructure for regulated environments, including lifecycle management, infrastructure qualification, and VPN/remote access controls.
Development and delivery of training tailored to quality system implementation and regulatory compliance.
On-site and remote vendor and subcontractor audits to assess compliance and quality of outsourced functions.
Oversight plans and ongoing oversight of outsourced manufacturing and clinical operations to demonstrate sponsor responsibilities are met.
Conducting Good Clinical Practice site audits to assess trial conduct, subject protection, and data integrity.
Development of quality manuals, SOPs, and documentation aligned to business plans and regulatory milestones.
Validation of software and infrastructure for regulated environments, including lifecycle management, infrastructure qualification, and VPN/remote access controls.
Development and delivery of training tailored to quality system implementation and regulatory compliance.
Expertise Areas
- Regulatory compliance and quality systems
- Audit and inspection readiness
- Clinical trial oversight and GCP compliance
- Computerized system validation and GxP IT
Key Technologies
- Computerized system validation (CSV)
- GxP computerized systems lifecycle management
- 21 CFR Part 11 / electronic records compliance
- GAMP 5 framework