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

  • Software, Security, and Compliance
At-line, in-line process monitoring

Account User/Group Creation & Configuration

  • Admin, IT admin, User, Power User, and Reviewer

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

  • Permissions, Data Acquisition/Saving, E-signatures, Security, Error States, etc.

Validation Report, Appendices, and Submission Preparation

System Release Documentation

Let us do the work, so you can leap months ahead.

Request Validation Services