NOVOSTI

Your new issue of Data Integrity Insights is here!

Your new issue of Data Integrity Insights is here!

Agilent Technologies
DATA INTEGRITY INSIGHTS
Traditional approaches to laboratory data integrity are no longer enough to meet today’s increased scrutiny of your computerized systems. To successfully present your results, you must be prepared to prove that your data have not been compromised.

Data Integrity Insights helps your lab stand up to regulatory examination by keeping you informed about the latest FDA and global enforcement trends, and the strategies you can use to stay compliant.

Analyst-to-Analyst Webinars
Demystifying Software Validations Demystifying Software Validation

The term “software validation” can trigger many responses, including dread and confusion. In this Webinar, you’ll learn how to take a methodical, practical approach to system definitions and software validation.

View now
The Front Lines of Data Integrity
Documents
Understand the FDA’s current thinking about software validation

The US FDA has issued guidance documents regarding software validation. Click the titles to view.

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application

Failure to meet FDA guidelines:
The consequences

“Your response is insufficient because it did not specify who holds administrative privileges on your computers, or address the significant pattern of data manipulation (e.g., deletions, date/time alterations) we observed at your facility…”

Read real FDA warning letters

Exclusive Insider Offers
Reduce Risk in a Data Integrity World: Approaches to Ensure Compliance Demystifying Software Validation
eBook: Reduce Risk in a Data Integrity World: Approaches to Ensure Compliance

Gain new insights into keeping your data secure—and making sure your systems comply with FDA guidelines.

Editorial: Welcome to the Brave New World of CSV?

Computerized system validation (CSV) isn’t rocket science. It’s the application of good software engineering practices in the context of a regulated laboratory.

White Paper: Demystifying Software Validation

Eliminate the confusion and anxiety of software validation. This white paper will help you think critically about risk-based validation, revalidation, and the differences between qualification and validation.

Download now
Read now
Read now
Innovations with Purpose
OpenLAB Achieve the highest level of data integrity: OpenLAB CDS

Be confident in your chromatography data system’s ability to keep your lab data consistent, accurate, and protected.

Learn more
CrossLab Minimize regulatory stress: CrossLab compliance consulting

Let Agilent help you more efficiently minimize your regulatory risk, and stay current with industry standards and best practices.

Learn Learn more
Data Integrity Live
Philadephia 23rd Annual IVT Validation Week

October 17-19, 2017
Philadelphia, PA

The gold standard for validation training is back with comprehensive information on new global regulations, technology advances, and industry case models.

Register now
Stay In the Loop
View our previous issues and stay informed about the latest FDA and global enforcement trends.

ALIFAX SEMINAR: Nova, brza rješenja u bakteriologiji za kliničku učinkovitost

9.11.2018

Pozivamo vas na seminar pod nazivom Nova, brza rješenja u bakteriologiji za kliničku učinkovitost, u organizaciji tvrtki Alifax …

VIŠE

Multiply You Experimental Possibilities – New Agilent Cary 3500 UV-Vis

6.11.2018

Confidently perform multiple experiments, simultaneously The innovative new Agilent Cary 3500 UV-Vis will transform your laboratory. …

VIŠE

Pridružite se Agilentovoj zajednici

3.10.2018

Agilentova zajednica je znanstvena online platforma s fokusom na uzajamnu pomoć među korisnicima. To je …

VIŠE

FEATURED TRAINING & EVENTS

FEATURED PROMOTIONS

Have you discovered Agilent CrossLab yet? Agilent CrossLab delivers vital, actionable laboratory insights that drive …

VIŠE