Category: Validation

CSA IN ACTION A Risk Based Approach Preparing and testing documentation on average takes 80% of the time dedicated to validation. The objective of CSA

SHIFTING THE VALIDATION PARADIGM: From CSV to CSA. In 2011 the FDA launched their “Case for Quality”.  The FDA carried out an in-depth review on

Remote Versus On-Site The 2019/2020 period has been unique for the Medical Device Industry around the world. This has led companies to seek innovative methods

Here’s What You Need To Know… What Is Process Mapping: The purpose of Process Mapping is for organisations to improve efficiency. It is the gathering

Do you need help Validating Software and Systems to meet Regulations? Have you a temporary shortfall in testers or qualified Validation Engineers to manage current

What is Critical Thinking? Critical thinking is a method of objectively analyzing the data on any problem, subject or content in order to form a

Integrity in the Data LifeCycle If you are working with data in a Life Sciences organisation it is imperative that you can guarantee its integrity

What is “Data Governance”? (Data Governance -MHRA) * – The arrangements to ensure that data, irrespective of the format in which they are generated, are

Audit Trail Reviews for Data Integrity Audit trail is a record of the “who, what, when, and why” of a record. Data integrity arrangements must

Data Integrity Data Integrity is not a new requirement in medical device and pharmaceutical industries – it features heavily in Chapter 4 of the EU