PSC Biotech helps the client by generating and completing new SOPs as well as reviewing, updating and completing pre-existing SOPs for their facilities and laboratories. Examples of the SOPs that need to be developed include:
PSC Biotech® guided our client, a leader in the animal health industry, through the regulatory strategy for their vaccine’s international expansion by developing formats for submission of critical quality, safety, and efficacy data and authoring CTD Modules 1-5 for submission to the respective regulatory agencies.
PSC® performed technical writing support for 3 months utilizing a Senior Technical Writer. The project started on 6/10/2020 and concluded on 9/10/2020 or agreed upon timeframe. PSC® provided project schedule oversight through the entire project.
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.
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.
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.
