 |
White paper overview
- Learn why pharma and biopharma laboratories should increasingly digitalize their laboratories
- Understand the key business benefits that such digitalization brings – not only to the laboratory but to the entire company's value chain
- Understand how digitalization supports effective risk and knowledge management
- Prepare for the increasing regulatory expectations in relation to automation and digitalization
Pharma and biopharma companies stand to benefit enormously from the increased digitalization of their laboratories.
On the one hand there are substantial benefits in terms of time, accuracy, better trend analysis, and faster release of product from QC labs, for example, and on the other hand digitalization is increasingly expected from the various regulators.
As a case in point, two particular proposals within the updated EU GMP Annex 11 highlight that:
- There is an increased expectation of advancements in data integrity, ideally using technical solutions and automation.
- An expectation of overall digital transformation within laboratories.
This white paper was co-authored by Pete Baker, Bob McDowall, and Gunnar Danielson
Peter Baker
Peter Baker spent 11 years working as a US FDA Drug Investigator and was the FDA's Investigator of the Year in 2013. He has substantial experience in uncovering serious breaches in data integrity and has a special interest in big data management and compliance with Annex 11/21 CFR Part 11. Peter now works as an independent consultant helping companies to improve the quality of medicines through good data management.
Bob McDowall
Bob is an analytical chemist with over 50 years of experience in the pharma and life sciences industry. In particular, he has over 35 years of experience in automating laboratories and providing consultancy and validation advice about laboratory computerized systems and informatics, especially LIMS and CDS. Bob has also recently authored a number of books, including: “Validation of Chromatography Data Systems, 2nd Edition”, “Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories 2019” and has written the “Questions of Quality” and “Focus on Quality” columns in the LCGC International and Spectroscopy magazines, respectively.
Gunnar Danielson
Gunnar Danielson leads METTLER TOLEDO's software solutions business development and consulting teams while having a core focus on digitalizing laboratories and on systems integration. Drawing on his 25 years in computer systems and business, Gunnar has extensive experience in laboratory workflow automation and data integrity. He is also the head of METTLER TOLEDO's data integrity group and contributes to industry standards and regulatory conversations.
