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Compliance, SOPs and procedural analysis

Key words – SOP, compliance, procedures, analysis, CFR Part 11, Sarbanes Oxley, SOX, Machine Directive

Compliance

Clear standard operating procedures (SOPs) underly efficient processes. They improve productivity and quality through clarity of understanding that ensures uniformity of performance and the avoidance of errors - both of which are often fundamental for compliance with industry regulations and standards. They are also the best way of avoiding disruption to production when team members move on, taking their know-how with them.

Producing clear SOPs requires skills in both procedural analysis and concise writing, and these are the skills I bring to this area.

I have worked with the analysis, development and rationalization of SOPs for FDA's CFR Part 11, Sarbanes Oxley and the EU Machine Directive, as well as analyzing procedures and writing countless SOPs for internal production processes.

SOPs

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CFDR 21 part 11

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Machine directive

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ISO 19600:2014 

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Compliance management systems — Guidelines

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Compliance, SOPs and procedural analysis
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