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Siegfried Schmitt
Articles
Improve Automation, but Beware of the Pitfalls
Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.
The Value of FDA 483s and Warning Letters
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
Computerized System Descriptions–How Hard Can It Be?
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
Auditing for Good Distribution Practices
Auditing distribution suppliers provides understanding and documentation of the services performed.