CGxP Writing Toolkit
The CGxP Writing Toolkit is a comprehensive suite of trainings, SOPs, templates, and exercises to help any organization ensure that they are using proper standards and techniques necessary to produce accurate, compliant documents with FDA diction.
Do the documentation and writing standards at your company help or hinder you and your company’s long-term success?
In a CGxP environment, high-quality documents ultimately are the most valuable contribution individuals can make to their company’s long-term success. Documents record the past (e.g., batch records, investigation reports), instruct the present (e.g., SOPs), and direct the future (e.g., project plans).
Therefore, authors need to constantly strive to follow best practices for CGxP writing to maximize their investment of time and energy for the following reasons:
- To meet regulatory requirements.
- To effectively record and share current information, knowledge, and understanding that can be reliably and confidently leveraged in the future.
- To provide a strong foundation for related documents.
This toolkit provides CGxP documentation and writing standards that can be customized to fit any organization.
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