About this Project

OBJECTIVE

Technical Writing Services.

SERVICES

Provided technical writing services. The scope of technical writing to be provided included: Lot release- was actually researching errors and inconsistencies in existing records.  Also generated SOP’s for equipment facilities and utilities.

PROJECT SUCCESS

PSC® provided two experienced technical writing consultants for this project. The project successfully took around 1020 hours.

About this Project

OBJECTIVE

Client required assistance with technical writing on their projects.

SERVICES

PSC‘s® technical writer for this project primarily wrote, edited, and reviewed cGMP documents, Systems Specifications, SOPs, and related materials while maintaining standardized documentation practices for recording details of new processes. The technical writer maintained standardized language and documentation practices that allowed  execution of documents. The technical writer established and supported documentation practices that reduced review times and deviation by researching errors and inconsistencies in existing records and communicating effectively with appropriate personnel. The technical writer also worked with internal teams to understand system documentation requirements, analyzed current content to make improvements as necessary, and maintained documentation pertaining to systems operation and user documentation.

PROJECT SUCCESS

PSC® successfully assisted in technical writing for quality and cost-effective projects over the course of 7 months.

About this Project

OBJECTIVE

The Facilities Department in Waco, Texas required technical writing support for engineering projects and new equipment implementation.

SERVICES

PSC provided the Texas facility with technical writing support for engineering projects and new equipment implementation. Documents included Functional Risk Assessment, System Risk Assessment, Standard Operating Procedures, Work Instructions, Traceability Matrix, User Requirement Specifications, and Functional Requirement Specifications.

PROJECT SUCCESS

PSC performed the technical writing tasks per client policies and the industry standard in a timely manner within the timeline.

About this Project

OBJECTIVE

Required support for the compliance and validation activities related to the Software Transition Project for 12 months.

SERVICES

PSC® provided Validation and Compliance Technical Writing for the transition of computerized systems for the client. Responsibilities included but were not limited to generation, re-visioning and execution of the following SDLC validation documentation: Compliance Analysis, Compliance Plan, User Requirements, Functional Requirements, Test Protocol, Test Execution, Traceability Matix, and Compliance Report of the computerized systems.

PROJECT SUCCESS

Over this year long project, the PSC® Project Team, which consisted of 5 Validation Engineers, successfully maintained a strict timeline and adhered to the project budget, along with successfully completing the technical writing, validation compliance of the transition of the computerized system.

About this Project

OBJECTIVE

Required non-medical technical writing support.

 SERVICES

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®.

PROJECT SUCCESS

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.