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Mitchel Kevern, MEM
Senior Project Manager
Kymanox

CGxP Documentation and Writing Standards Toolkit

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.
Product Description

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
  • GMPPENS
TOOLKIT TYPE Free Starter Standard Pro
Purchase Price $0 $199 $399 $479
CGxP Formatting and Writing Standards Summary Presentation (9 slides) PDF yes yes yes yes
CGxP Formatting Standards Presentation (Editable/32 slides) Powerpoint no yes yes yes
CGxP Writing Style and Standards Presentation (Editable/23 slides) Powerpoint no yes yes yes
CGxP Formatting Standards SOP (20 pages) Word no no yes yes
CGxP Writing Style and Standards SOP (14 pages) Word no no yes yes
Procedure and Template for Writing SOPs and Technical Reports (14 pages) Word no no yes yes
Memorandum Template (1 page) Word no no yes yes
Exercises with Answer Keys (37 pages) Word no no yes yes
Workshop Agenda (1 page) Word no no no yes
GMPPENS (80 count) GMPpens no no no yes
Purchase
Return on Your Investment

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.

   
   
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