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Computer System Validation Services

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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 PATsmart™ SoloVPE and FlowVPX Systems, you can be confident that your computer validation will be completed in days and in compliance with regulatory requirements.

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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.

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