| Life Sciences | |
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| Strategic Consulting | |
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Quality & Auditing |
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| GSP Bio |
Quality Assurance and compliance issues create pressures for every life science organization. Often the IT organization and QA organization find themselves in conflict due to the absence of process and procedure, incomplete understanding of a risk based approach or simply the lack of familiarity with the drivers behind the department’s goals.
Court Square’s subject matter experts can support a company’s compliance needs from assessment to implementation to full audit management.
| Quality Assurance (QA) Services: Court Square provides quality assurance resources for critical areas such as quality manual creation, compliance plan development, business and regulatory risk assessments. | Infrastructure Qualifications: Court Square QA experts conduct qualifications of infrastructure based on applicable regulatory requirements (FDA 21 CFR Part 11, SOX etc.), and the client's own risk-based approach. Court Square performs qualifications of facilities including datacenters, hardware, and networking. Final deliverables include custom policies and procedures with client training and knowledge transfer to achieve on-going operational compliance. | Application Validation: Court Square’s validation services range from creation of processes and procedures for validation to the actual implementation of a validated application. |
Court Square offers audit services in multiple areas within a company’s IT and system environment. All audits come with a final report with vulnerabilities prioritized and remediation recommendations. Our quality experts can also implement any remediation issues found in audits done by a client, a third party audit or our own auditing team. In addition, Court Square offers complete audit management services covering every GxP area. We eliminate the need for confusing multiple third party auditing services and the difficult task of coordinating information from multiple sources.
