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Polaris has decades of experience writing SOPs for investigative sites, sponsors, CROs, IRBs, nonclinical laboratories, manufacturing facilities, IT organizations, and technology-related vendors. We begin by looking at your existing processes to make sure they comply with current regulations and guidelines, are aligned with industry best practices, and clearly outline roles and responsibilities. From there, we can develop new SOPs, or revise your existing ones. Afterward, we can create customized training courses to educate your staff on your company’s procedures.
SOPs should be clear and detailed enough to allow staff members to know what is expected of them, but not so detailed that non-compliance with your own SOPs becomes an issue. Polaris SOP Writers can help you with:
Polaris can perform SOP gap analyses and develop SOPs in the following areas:
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Over 25 Years of Compliance and Quality Consulting for the Life Science Industry
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SERVICES
Good Clinical Practice (GCP) Audits Good Laboratory Practice (GLP) Good Clinical Laboratory Practice (GCLP) Audits Good Manufacturing Practice (GMP) Audits Computer System Validation (CSV)/Part 11 Audits CAPA and Remediation SOP Development Strategic Quality Consulting Clinical Project Management (CPM)lljljkkljlkjlkjljk |
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