Documentation:
Our staff has the experience to create technical documentation such as:
- Global/Local Policies and Procedures
- SDLC documentation: Validation Plans, Data Migration Plans, System Test Plans, Validation Reports, System Test Reports, IQ, OQ, PQ/UAT, Requirements Specifications, Test Scripts (Automated and Manual), Test Cases, Design Specifications, Testing Reports, Gap Analysis, Feasibility Studies
- Regulatory Submissions: IND, NDA, 510K
- RFPS, Warning Letter "483" Responses, Audit Reports, Project Plans, etc.
We will create as many documents or as few as required. Contact us so that we can discuss your documentation requirements. |
