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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.

Computerized System Validation:
Computerized Systems Used in Clinical Trials
Institute of Validation Technology
Food & Drug Administration (FDA):
FDA Website
FDA News Website
CBER
CDER
Sarbanes-Oxely
Sarbanes-Oxley Forum
Sarbanes-Oxley Forum2
Sarbanes-Oxley Law
HIPAA
HIPAA Advisory
HIPAA Compliance
HIPAA Training
OTHERS
Code of Federal Regulations
National Institutes of Health

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