Pharma and Biotech Quality System Support
With experts who specialize in every area of a QS, NSF helps you develop best practices, coach, mentor and train staff in investigations, simplify documentation and evaluate the costs of poor quality.
Implementation of quality systems (QSs) can be difficult. We believe your QS content should be simple and easy to follow, from your quality policy and quality manual to your procedures and work instructions.
NSF's evaluation, diagnosis, guidance and effectiveness (EDGE) tool assesses your existing QS and offers recommendations for improvement. NSF's team of experts has detailed knowledge of every QS area. We assign the right expert to review and update your policies and procedures, ensuring they meet global regulatory expectations and requirements.
We review and improve processes, offer staff training and qualify people to conduct investigations. We can also support your quality risk management and investigation processes, including root cause analysis. Let us help you develop appropriate corrective actions and preventive actions with sound effectiveness checks.
NSF simplifies standard operating procedures (SOPs) and batch manufacturing records (BMRs) to ensure they are accurate and easy to follow. We work collaboratively to identify the key steps in a procedure or manufacturing process, then design documents using flow charts and decision trees. Our simplification process results in more manageable documents and fewer staff errors.
Cost of Poor Quality Analyses
Highlight manufacturing or testing processes that need improvement with a cost of poor quality analysis. Use cost of poor quality data to encourage senior managers to invest in necessary improvements by shifting the costs associated with rejects, rework, deviations and investigations to positive investments in your company.