Validation

Improve processes through designed experimentation
By InSite Technologies Inc.
White paper
This white paper from InSite Technologies Inc. describes how one medical device manufacturer attained significant improvement in advancing its process understanding without having to revalidate. The company did this using designed experimentation.

System validation with Experion PKS
By Honeywell Process Solutions
White paper
This white paper by Honeywell Process Solutions describes the FDA's 21 CFR Part 11 validation process regarding electronic records and signatures and discusses how Honeywell can assist with project validation.

Business systems validation for Pfizer production plant
By ABB Inc.
Case study
In this case study, ABB defines a practical validation strategy and detailed implementation plan for a flagship Pfizer plant that produces Lipitor, maintaining Pfizer's excellent regulatory compliance record during a major software transition.

Speed, communication and high-quality science from MDS Pharma Services
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services supports Roche Pharmaceuticals to prepare for an FDA audit by undertaking lot-to-lot validation and other biosafety tests for reagents used in diagnostic kits.

Catching the Drift: What the Specifications of Your Humidity Measurement ...
By Veriteq Instruments Inc.
White paper
Understanding how RH measuring devices function and how those functions are commonly represented in product specifications can help with selecting the right system. Knowing what to look for in product specifications can also initiate incisive questioning of manufacturers about the accuracy of their humidity measuring systems.

Regulatory compliance and validation services
By ABB Inc.
Product collateral
ABB’s regulatory compliance services can assist in dealing with the increasing demands and complexity of national and international regulations.

Method validation, experience and 'getting it right' the first time
By MDS Pharma Services
White paper
This white paper by MDS Pharma Services is an interview on method validation with Dr. Sheila Tenneson, MDS director of analytical development in the pharmaceutics division, who describes the role of validation in pharmaceutical development and validations performed at MDS facilities.

Method validation for laser diffraction measurements
By Malvern Instruments Ltd.
Application note
In this application note, Malvern Instruments Ltd. describes the need for method validation for and outlines some of the important variables that should be assessed when considering the precision of laser diffraction measurements.

Cleaning validation references
By Alconox Inc.
Application note
In this application note, Alconox Inc. describes cleaning validation for pharmaceutical and medical devices. It explains how to identify residues, select a sampling method and writing procedures and training, and offers a directory of methods for each detergent, among other tips.

Bioanalytical method validation
By FDA Center for Drug Evaluation and Research
White paper
This white paper by the FDA's Center for Drug Evaluation and Research (CDER) provides guidance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability and bioequivalence studies requiring...