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Change Management in Cloud Systems
Cloud systems have come to stay. They brought multiple benefits but also a few problems for the pharmaceutical industry, being the most annoying one, the fact […]
Practical implementation of CSA – Lessons learned
While the official guide has not been issued yet, multiple details are available and had been gathered by TDV in several conferences and collaborations around the […]
Audit Trail Review & Data Integrity
Amongst the important changes introduced in the management and use of computerised systems as a consequence of the increasing expectations on Data Integrity assurance, is the […]
TDV News
A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been issued by the FDA this week. This is a […]
Looking for an opportunity in Life Sciences? Willing to be part of our team of consultants? Check this out! OPEN POSITIONS: Mid-senior & Junior […]
In July 2022 ISPE issued the second edition of the GAMP 5 guide. Since the issuance of the first edition in 2008, multiple changes have occurred […]
