SOPs and Regulatory Writing
Standard Operating Procedures (SOPs) are the foundation of a reliable quality control systems and efficient businesses.
SOPs are a comprehensive set of documents that clearly define how to complete a process in a step-by-step manner, as well as who is responsible for the process, what materials are required, and how the process is to be documented.
When it comes to the manufacture of regulated products like cosmetics, foods, health products, and medical devices, the regulations (for example, the Natural Health Product Regulations or Medical Device Regulations) tell you what you need to do, but your SOPs tell you how to do it. The associated records within the SOPs prove that you did it. SOPs need to be written for most aspects of your life-science business, and they can take the form of high-level documents describing general concepts and action plans or very detailed procedures that are considered step-by-step Work Instructions (WIs). The format can vary from text-based instructions to visual representations (flow charts) or use a mixture of the two. Once created, staff need to be trained on the procedures and monitored to ensure they are following them correctly. SOPs are constantly changing documents, which require review and revisions when practices change.
We recognize that each company is different, which means that your SOP needs are unique. Do you need SOPs that are visual? Cover various departments? Prefer step by step procedures? Our team of experts has written SOPs for hundreds of companies, and we take pride in creating custom SOPs that are actionable for your company. We can also help improve your existing SOPs or revise existing procedures to reflect new aspects of your business.
In addition to creating or revising your SOPs, our team of experts can assist you in writing various regulatory documents such as: packaging and labelling of clinical trial materials and approved healthcare products, cleaning and processes, stability programs, quality manuals, forms and templates to accompany SOPs, investigator brochures and updates, and annual product reports.