Do you have confidence in the quality of your manufacturing SOPs? Many companies do, yet "Procedures not in writing, fully followed" was the top GMP deficiency cited by FDA investigators in FY2019.
And what about the SOPs on the clinical side of the business? Are your study oversight procedures flexible enough to accommodate a risk-based monitoring strategy?
And of course, the computer systems that support your business require procedures of their own. Do you struggle with SOPs to address system selection, development, and control?
SOPs are not easy to write. You need them to be clear and concise, but you need them to describe complex procedures, supplement training, demonstrate compliance, maintain quality control, and provide you legal protection. SOP templates that you can download from the web are a decent start, but they fail to reflect your process flows, your unique business processes.
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 for you, or revise your existing ones. Afterward, we can create customized training courses to educate your staff on your company’s procedures.
Contact us and we’ll make sure your SOPs are the right fit for your site, lab, or facility.
Regulatory writing experts at Polaris can assist you with:
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Polaris Compliance Consultants, Inc.
1151 Executive Circle Suite 202
Cary, NC 27511-4589