GMP Proofreading


Your Proofreading Expert,
Danielle Giles

I have always been one of “those people” who notice spelling, grammatical, and formatting errors. I was even the go-to in school for proofreading of papers and essays, and that did not change as I entered the workforce. There is just something in my brain that can see the errors and wants to fix them.

During my 17-year career in the pharmaceutical/medical device industry, I spent a lot of time writing and editing all types of documents that a cGMP business requires as I worked as a Quality Specialist, Quality Engineer, and Director of Quality. I started with writing SOPs and work instructions, and before too long I was editing and approving protocols, investigations, contracts (including quality agreements), and reports submitted to the FDA and customers. What I found is that it is extremely difficult to both review for technical accuracy and proofread documents effectively — it is similar to proofreading your own work. After writing or editing documents, it can become difficult to see what is  actually written instead of what the brain thinks should be there.

Not only did I review internal documents, but I also reviewed documents vendors sent to me for approval. Even before reading the entire document, I would already have an impression of the quality of work by how it was formatted and presented. And if, for example, I was reviewing an investigation that was full of spelling and grammatical errors, I would find myself questioning how much time and effort was spent – and more importantly, the quality of that time and effort – digging into the root cause and corrective/preventive actions. I figured that if I had that reaction, others would, too. And after spending time in conferences and networking with others in the industry, I was certain I was not alone!

I get it — not everybody looks at these errors with such a critical eye, and there may not be a correlation between the quality of work and a few errors in the document. This is especially true when documents are translated into English.

But written word is one way we present ourselves to the world. It does have an impact on your company’s image and reputation.

My background includes a master's degree in Regulatory Affairs and Quality Assurance from Temple University. Whether your Quality Management System documents need a holistic review or you need to have a field alert quickly proofread prior to sending it to the FDA or customers, I am here for you. 

Let me use my experience and expertise to help you put that polished touch on your documents.