Non-Medical Technical Writing Support Project
About this Project
PSC provided the client with non-medical technical writing support including Data Science and Regulatory Affairs focused, a Pharmacovigilance process improvement initiative, and other Clinical Science process improvement efforts. Non-medical technical writing activities include the development, maintenance, and revisions of documents connected with Good Clinical Practice (GCP), Quality, Regulatory and Non-Regulatory expectations, Standard Operation Procedures (SOP) and other processes, and Document Impact Assessments. Over a duration of time, in-scope non-medical technical writing projects were expected to vary in number, size, complexity, and non-medical subject matter which were discussed between PSC project team and project sponsor(s) when assigned the writing project to PSC.
- Microsoft Office Documentum module (ADMS – an internal document repository)
- PEAK (Process Excellence and Knowledge – process map software)
- Adonis (similar to PEaK)
- SAP S/4 + MDG module
The PSC project team comprised of 6 Technical Writers, one of which was a Project Manager. The team successfully produced the non-medical technical writing project deliverables based on an agreed timeline with the client over the course of 8 months.
Errors & Inconsistencies In Existing Records
Validation & Compliance for Computerized Systems
Generation, Re-Visioning & Execution of Validation Documentation.