Validation Center
Computer System Validation News
Are you ready for the FDA guidance on Data Integrity and Compliance?
September 23, 2024The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is...
4 Types of Software Requiring Validation, 5 Regulatory Expectations
April 25, 2018Companies who are are new to computer system validation often ask us whether software validation is required for their s...
History of 21 CFR 11 Compliance
April 17, 2018Life Sciences companies that want to sell their products or services in the United States must comply with the 21 CFR Pa...
Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?
December 10, 2016In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide AP...
Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?
November 01, 2016In mid-2016, the World Health Organization (WHO) published the 2nd draft of Global Model Regulatory Framework for Medica...
New from PIC/S: Draft Guidance on Data Integrity
September 10, 2016Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has publishe...
Are you complying with the new FDA General Wellness Policy for Low Risk Devices?
August 19, 2016In July 2016, the FDA released Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices to cl...
Are You Following the FDA Medical Device Cybersecurity Guidance?
February 18, 2016In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety....
Are you ready for the FDA guidance on the design of Interoperable Medical Devices?
February 11, 2016If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just publis...
Are you complying with the European Commission's new version of Annex 16?
November 23, 2015In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical su...