Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say.
Inadequate process implementation is the top reason why drugmakers get slapped with warning letters, so it’s important that SOPs are task-specific and easy for a user to understand, Mukesh Kumar, a senior director at contract research group Amarex Clinical Research, said.
Companies should ask themselves if their SOPs are simple enough to make into a cartoon, Kumar said.
Drugmakers should use diagrams where necessary, and flowcharts with top-to-bottom instructions can be especially helpful for global pharmaceutical companies with a culturally diverse staff, Sally Breisch, chief operations officer and medical writer at Amarex, said.
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