GMP technical writing and documentation
Your documents are what inspectors read first, and what operators rely on every shift. We write the controlled documents a regulated facility runs on, so they are clear on the floor, consistent across the site, and aligned with the regulations that apply to you.
Documents written to be followed
The most-cited drug GMP observations come down to procedures that are missing, unclear, or not followed. A procedure that reads the way the work is actually done is easier to train on, easier to follow, and easier to defend.
We write new documents, rewrite legacy procedures, and build full document systems for new sites, delivered in your templates and ready for your change control.
What we write
Procedures and instructions: SOPs, work instructions and job aids, master batch and packaging records, forms and logbooks, equipment operation, cleaning, and maintenance procedures, and training materials.
Quality and validation documents: risk assessments, deviation and investigation reports, CAPA plans, change control assessments, validation master plans, URS and traceability matrices, protocols and summary reports, P&IDs and facility layouts, and supplier qualification documents.
What we deliver
- Standard operating procedures (SOPs)
- Work instructions and job aids
- Master batch and packaging records
- Forms, logbooks, and checklists
- Validation master plans, protocols, and reports
- Risk assessments and investigation reports
- P&IDs and facility, equipment, and utility layouts
- Quality manuals and site master files
- Training materials and assessments
Regulations and standards
- 21 CFR 211.22(d), 211.100, and 211.186
- 21 CFR Part 11
- ISO 22716
- ALCOA+ documentation practices
Common questions
Can you write in our existing templates and document system?
Yes. Every deliverable is formatted to your templates and numbering, and routed through your change control, whether your records live on paper or in an electronic QMS.
Do you rewrite legacy SOPs?
Yes. We review existing procedures against current practice and requirements, then rewrite them so the steps match how the work is performed and the responsibilities are clear.
Can a document project be done remotely?
Most of it can. Drafting and review work well remotely. Floor walk-downs and operator interviews are done on site across San Diego County and Southern California, or by video for remote clients.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.