Senior Project Manager
CGxP Documentation and Writing Standards Toolkit
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. The professional package includes the following editable documents:
- CGxP Formatting Standards Presentation
- CGxP Writing Style and Standards Presentation
- CGxP Formatting Standards SOP
- CGxP CGxP Writing Style and Standards Standards SOP
- Procedure and Template for Writing SOPs and Technical Reports
- Memorandum Template
- Exercises with Answer Keys
- Workshop Agenda to host your own training
Kymanox estimates that it would take a qualified contractor 120 hours (80+40) to complete the work included in this package.
This estimate is based on our extensive experience creating these and other templates and procedures, as well as averages that we have observed across the industry.
Please use the calculator at the right if you would like to see how your own calculations affect the dollars and time saved by purchasing our package. You can replace the numbers for "Effort Hours to Complete" as well as "Labor Rate" in order to see differences.
Labor Rate is defined as the overall cost of one employee per hour (including pay rate and benefits), or the overall cost of one qualified contractor per hour. Kymanox estimates this at $60/hour for a qualified contractor.
Available Hours Per Day refers to the number of hours a single resource has to work on the project per day. 8 hours assumes that the resource is fully dedicated to the project.