Does Life Technologies offer a Computer System Validation Service?

Yes, our experienced professionals perform Computer System Validation Services on various platforms.

Does Life Technologies provide 21 CFR Part 11 compliant software?

Where can the requirements be found based on my regulated status?

What is GxP?

Is a risk assessment mandatory to be compliant with GxP requirements?

Which Life Technologies™ platforms have software that can enable compliance with certian GxP and Part 11 requirements?

Does Life Technologies operate under ISO standards?

Is a vendor audit enough to ensure that software features such as audit trails and electronic signatures are all present and compliant?

When does Part 11 apply?

What is GAMP5?

How does quality system management differ among GxP?

How do GxP responsibilities differ?

What are some frequently cited issues?

What are the main cases of incorrect test data?

Does Life Technologies offer flexible pricing plans?

TERMS

What is an IQ?

Instrument Qualification (IQ) procedures verify at the time of the testing, that instrumentation is delivered and installed according to the stringent specifications set by Life Technologies, documenting the shipment integrity, components, and compatibility with the system configuration.

What is an OQ/IPV?

Operation Qualification/Instrument Performance Verification (OQ/IPV) verifies and records an instrument’s ability to meet specified performance criteria after installation, repetitive use, relocation, or other major service events. The OQ/IPV service involves comprehensive testing of the complete system using established conditions and known sample characteristics, verifying the accuracy and precision of the instrument. Instruments should be regularly tested to confirm high-quality performance and identify possible impact due to normal wear or inadequate user maintenance.

What is an FSE?

A Field Service Engineer (FSE) is an experienced and certified representative trained to repair and service Applied Biosystems™, Invitrogen™, and Ion Torrent™ instruments using only factory-certified replacement parts.

What is the Remote Service Center?

The Remote Service Center is a phone-in facility where senior service engineers aid in solving instrument and computer validation problems before an FSE is sent out to your laboratory. Often a Remote Service Center representative can help fix your problem quickly and easily, thereby eliminating the need for a field visit.

RESOURCES

The discussion provided herein is for informational purposes only and is not intended to give any regulatory or legal advice.

If you require further customization for your validation process, or a broader scope of validation services, please contact a Life Technologies sales or service representative by email at service.sales@lifetech.com, or via telephone at 800 327 3002 (toll free in the US only).

To contact a compliance and validation expert directly, please email complianceservices@lifetech.com.