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
Dry Run Dry Runs are often misunderstood. While they can be of huge benefit to a project, time and again they do not get factored
Good Automated Manufacturing Practices GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International Society for Pharmaceutical Engineering