Data Integrity and Digital Workflow Guidance for the Contemporary Pharma Lab
April 16, 2021
Correct data is fundamental in a GxP quality system. This podcast will discuss what needs to be put in place to achieve data integrity and minimize the risk for an organization. We will discuss how to achieve data integrity and give real examples from FDA warning letters about the most frequent violations. To prevent violations, processes and systems should be designed to follow the ALCOA principles which will be explained in detail. We will review how a modern lab instrument can provide all the technical features which are needed to automate processes, ensuring that data integrity compliance issues are not created. As an example, we will present the functionalities of Cubis II, the 2nd generation premium laboratory balance from Sartorius. We will also discuss software applications for QC- or production-relevant applications like Tablet & Vial checker (Uniformity of dosage, USP chapter ), Loss on Drying (USP Chapter ), Standard preparation (USP Chapter ), Pharma Filling (Transfer of liquid products) or MYCAP CCX (Transfer of media and inoculum). The software applications safely guide operators through the workflow, automatically calculate the results and have conformity checks included.