As the pharmaceutical world is becoming more data-driven, you’ll need to pay closer attention to how your pharmaceutical company’s culture and operations ensure the completeness, consistency, and accuracy of data. Data specialists call this _data integrity_. Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA. Similarly, data must be complete, consistent, and accurate throughout the data life cycle, according to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceutical Inspection Co-operation Scheme.
The first section of this e-book provides recommendations on people-related advice. The first article gives more of an introduction on what data integrity is and examines how your company’s quality culture can assure data integrity. The following article shares five misconceptions about what data integrity is and is not. The next article shares eight steps for your company to prepare for the FDA’s upcoming “data effect” tsunami, and those steps include both people-related and technology-related steps.
The next section of the e-book delves into best practices for data integrity along the pharmaceutical value chain, including what to audit in laboratory information management systems (LIMS) and how to prepare for that audit, important cGMP considerations for implementing electronic batch records, how to audit electronic batch records, and how to address data integrity in your supply chain risk management. The e-book concludes in sharing nine pitfalls to avoid as you journey deeper into today’s world of data integrity.