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ValGenesis Blog (4)

The ValGenesis blog is dedicated to the best practices, insights and trends in validation for the life sciences industry. (4)

May 25, 2017

Risk Management for Medical Devices

Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.

May 25, 2017

What is wrong with traditional Equipment Validation?

In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost.

April 28, 2017

Object-Oriented Validation

ValGenesis (VLMS) has capitalized on delivering functionality to support object oriented validation. Here you can create requirements as objects, and these can be shared.

March 13, 2017

Data Integrity by Design

Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).

February 24, 2017

Validation and Calibration in the Life Science Industry

Validation and calibration are different; calibration requires assessing the accuracy of instrument results by measuring the variation against a defined standard to determine the relevant correction factors.

January 31, 2017

Cleaning Validation Requirements for the Life Science Industry

Cleaning Validation is a manual paper-based process that is very inefficient and time consuming. ValGenesis is a validation lifecycle management system that enables paperless cleaning validation and integration of all related data.