System validation is a time-consuming and expensive process that
is a crucial part of the vast majority of clinical and safety
application implementations. BioPharm Systems' dedicated team of
validation and compliance experts has developed numerous validation
packages that save you time, money, and resources.
Our validation packages contain a comprehensive set of document
templates, ready for customization to meet regulatory and business
needs.
Each validation package contains the following
components and templates:
- User Requirements Specification
- Traceability Matrix
- Test Scripts
- Validation Plan
- Test Incident Report Form
- Validation Summary Report
- Protocol Template(s)
- Protocol Execution Summary Report Template(s)
BioPharm Systems offers validation packages for several
Oracle Health Sciences applications, including:
- Argus Safety Suite
- Adverse Event Reporting System (AERS)
- Oracle Clinical
- Remote Data Capture (RDC)
- Thesaurus Management System (TMS)
