GMP Technical Writers
Our GMP technical writers are carefully recruited to not only provide you with an experienced technical writer who specialises in writing in plain language but who also brings GMP consulting strength to your project.
This means that our writers understand documentation change control and document approval processes in a GMP environment as well as being able to provide broad GMP consulting across a range of subjects.
We use process mapping techniques to ensure your procedures are documented logically. This ensures information isn’t duplicated across multiple procedures and reduces confusing cross referencing.
We can even run process mapping sessions with your subject matter experts to ensure your team is aligned on how your processes should run before the writing commences reducing review and approval time.
Writing in Plain Language
Our passion for writing in plain language means we deliver documents written in simple language, even for the most complicated processes, as well as being:
- written in active language
- well laid-out to reduce incorrect data entry and misunderstanding by end-users.
Our past projects include:
- Integrating new facilities and equipment procedures into existing QMS documents from Manufacturing records through to equipment registers.
- Process mapping and developing documentation plans to support green field manufacturing facilities.
- Coordinating large scale document reviews of QMS procedures to reduce document numbers and improve document readability and useability.
- Training plain language writing techniques to ensure document improvements can be sustained after your documentation project has been completed.
- Developing templates to help organisations standardise their styles and present a more professional image.
- Writing and updating QMS to ensure core procedures reflect current GMP.
We can also work with your document management team to help ensure your QMS document management processes are meeting both GMP and business needs.
User friendly (including Auditors)
Our writers have backgrounds from across all areas of Life Science industries including validation, operations and Quality Assurance. Their practical back-grounds help to ensure your documents are user friendly for the intended audience as well as meeting regulatory requirements.
Organisational change management
We can also provide experienced Organisational Change management consultants to help integrate change throughout your organisation.
We can assist you with:
- Standard operation procedures (SOPs) and Operating Instructions
- Batch records
- Registers and forms
- Process flow diagrams
- Scientific reports and protocols
- NDAs, and other regulatory documents
- Power point presentations
- Proof reading services
- Writing in Plain Language training
- Tender writing