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Within a validation life cycle, stage 3 (ongoing/continued process verification) is the longest stage. Its purpose is to demonstrate the “state of control” and enable the identification of drifts and shifts. Many companies now use statistical process control (SPC) for this purpose. However, there are many possible applications for SPC in the GMP environment. We would like to learn more about these and therefore ask you to answer the following 10 simple and quick questions.

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How many employees does your company have?
What products does your company manufacture?
(please select all that apply)
In which areas do you already use SPC?
(please select all that apply)
For which puposes do you use SPC?
(please select all that apply)
Which types of control charts do you use?
(please select all that apply)
Do you have any problems with SPC?
Which statistical methods do you use to evaluate the control charts?
Do you use process capability indices to evaluate your processes?
What is your threshold value when using process capability indices
What software do you use to run SPC?
Thank you for your time and input.

Your ECA Team
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