Regulatory Compliance / QA Consulting
Risk Assessment / Gap Analysis
CSI can provide a risk assessment for your organization that will identify existing compliance, strategic and operational risks for Management. Compliance risks are issues that could lead to an audit finding of non-compliance with applicable regulations. Strategic risks arise if an audit uncovers noncompliance or an unacceptable operation, which could result in a loss of business and a negative reputation. Additionally, operational risks involve such issues as inefficient use of resources and unnecessary costs.
CSI has performed numerous audits of vendors of software products, contract service companies, technology service providers, clinical laboratories and data management organizations on behalf of our domestic and global pharmaceutical, biotechnology and contract laboratory clients. The audits were performed to determine the level of compliance with FDA regulations and guidance regarding computer system validation, GLP/GCP/GMP requirements, and 21 CFR Part 11, and to minimize business and technical risks to the purchaser. These audits are formally documented in vendor audit reports with extensive and detailed recommendations for corrective action, including reference to the relevant regulations and guidance.
Remediation Planning / Monitoring
Our regulatory compliance assessments and vendor audits often result in numerous findings and recommendations. CSI has been successful in assuring a complete and thorough completion of the identified remediation tasks and sub-projects. We have assisted both the sponsors and vendors in assuring that all regulatory compliance issues are adequately resolved through a structured process of planning, progress monitoring and reporting.
Quality Management and Compliance Consulting
CSI services include quality management and compliance consulting to assist companies with the development or improvement of quality assurance, quality control and quality management processes, procedures and controls. CSI can provide expert reviews of validation strategies, development methodologies, company policies, procedures and techniques. We can either provide our recommendations in a formal report that provides strategic and tactical improvements in policies, procedures and documentation, or our trained personnel can write missing or deficient quality management documents.
Scientific Writing (SOPs, validation reports, regulatory reports)
CSI development services begin with an audit of the existing SOPs. After establishing what your specific needs are, we can develop custom or generic SOPs specifically for the respective organization, process or system.