Standard Operating Procedures (SOPs)
& Regulatory Writing

SOPs

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 2017.

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, 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, 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, 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.