Do you have confidence in the quality of your manufacturing SOPs? Many companies do, yet “Inadequacy of Written Procedures” constituted four of the top six GMP pharma deficiencies cited by FDA last year. 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?
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, 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 way of doing business.
Polaris has decades of experience writing SOPs for investigative sites, sponsors/CROs, IRBs, nonclinical laboratories, and manufacturing facilities. We begin by looking at your existing processes to make sure they comply with current regulations and guidelines, and are aligned with industry best practices. 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