Computer System Validation Services
Let us expedite the process, so you can concentrate on the bigger picture
The Computer System Validation (CSV) process is time-consuming and can require dedicated resources, in some cases, for up to 9 months. Let our trained Repligen Support Specialists do the work for you. With our years of experience performing validations with our variable pathlength spectroscopy software for CTech™ SoloVPE and FlowVPX Systems, you can be confident that your computer validation will be completed in days and in compliance with regulatory requirements.
What's included in your Validation Services?
Validation services can be performed on-site or remotely depending on your needs and timing.
| Validation Requirements | Include |
|---|---|
|
Initial Configuration and User Account Control (UAC) Setup
|
At-line, in-line process monitoring |
|
Account User/Group Creation & Configuration
|
✓ |
| New Technology File System (NTFS) Created and Secured with Permissions |
✓ |
| Configure Parameters for Managing/Administration |
✓ |
| Advanced Security Permissions (access, folders, and database) |
✓ |
| Set and Test Audit Trail/Data Integrity |
✓ |
| Verify Compliance with Test Case Protocol |
✓ |
|
Verify all Functionality and Operations Execute Correctly
|
✓ |
| Validation Report, Appendices, and Submission Preparation |
✓ |
| System Release Documentation |
✓ |