I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning the process and getting the team trained to understand the requirements for the quality manual, quality procedures and records.
Within the small biotech company, as a clinical manufacturing scientist, my team would constantly be working to formulate SOP’s and identify problems that came about during the manufacturing process and after production runs work closely with QA to provide feedback to the quality documents.