White Papers


Discover how you can manage your Validation process 100% paperless achieve and operational excellence through our educational white papers. Topics include industry regulations, our technology features and solutions, providing a close-up look at many of the risk, validation compliance and quality issues impacting businesses today.

Compliance with 21 CFR Part

Based on the inherent productivity gains associated with the implementation of computer systems, firms operating under regulated United States Food and Drug Administration (US FDA) industries have sought to leverage computer technology as a means of gaining a competitive advantage in the market.

Top 10 Reasons

Validation systems are still almost entirely manual or consist of a number of disparate, uncoordinated systems. Inefficiencies caused by human error cost manufacturers millions of dollars annually, increase product time-to market,and introduce quality problems that can result in regulatory actions including stringent penalties. Validation deficiencies are still the number one reason for the issuance of FDA warning letters.

Blood Establishment Computer System (BECS)

FDA's guidance document titled Blood Establishment Computer System Validation in the User's Facility provides assistance to blood establishments in developing and maintaining a validation program for Blood Establishment Computer System (BECS). According to the guidance, this program should be consistent with recognized principles of software validation, quality assurance....

ASTM E2500 Standards

Regulated Pharmaceutical, Biotech and Medical Device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while safeguarding product quality and patient safety. Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or the manual approach to validation.

Compliance with EU Annex 11

Based on the inherent productivity gains associated with the implementation of computerized systems, companies operating under the scientific European Medicines Agency (EMA) and its regulatory branches have sought to leverage computer technology as a means of gaining a competitive advantage in the market...
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