Data integrity and digital workflow guidance in a contemporary pharma lab
ABOUT THIS WEBINAR
Correct data is fundamental in a GxP quality system. In this on-demand webinar we discussed what needs to be put in place to ensure data integrity and minimise the risk for your organisation. We also discussed how to achieve data integrity and give real examples from the US Food and Drug Administration (FDA) warning letters about the most frequent and typical violations. To prevent violations, processes and systems should be designed to follow the ALCOA principles, which will be explained in detail.
We reviewed how a modern lab instrument can provide all the technical features that are needed to automate processes and which ensure that data integrity compliance issues are not created. As an example, we will guide you through the functionalities of Cubis II, the second generation premium laboratory balance portfolio from Sartorius. In addition, we discussed software applications (QApps) for QC- or production-relevant applications like tablet and vial checker (uniformity of dosage, USP chapter <905>), loss on drying (USP chapter <731>), standard preparation (USP chapter <129>), 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.
Cubis II is the only laboratory scale available on the market that offers full pharma compliance and state of the art digital workflow support without a need for any additional software.
Key learning outcomes:
- The importance of data integrity
- How to ensure data integrity and minimise the risk for your organisation
- How a laboratory balance can support full pharma compliance without a need for additional software
- How software applications with guided workflows help to achieve trustable and compliant results.
Dr Eszter Paldy, Product Manager Premium Weighing Solutions, Sartorius
Eszter studied biology at the University of Szeged in Hungary and earned her PhD in Pharmacology. Following her PhD, she was awarded with the Humboldt Fellowship for postdoctoral researchers and worked at the Pharmacology Institute of the Medical University in Heidelberg in Germany. During this time, she has further educated herself in business, project and product management. She joined Sartorius in 2017 where she works as a product manager for premium weighing solutions and is actively involved in new projects for product development.
Dr Holger Densow, Product Manager Premium Software Applications, Sartorius
Holger studied biology at the University of Bielefeld in Germany and finished his Doctorate in 2005. He then worked as a sales representative for two and a half years for a German biotech company. In 2008 he joined another company to manage lab instruments as a product manager. Since 2016 he has worked as a product manager at Sartorius and is taking care of software solutions for lab balances.