The advantages of a cloud solution for the pharmaceutical industry
In today’s world of enterprise IT, there is a question that most of the companies are facing: Can the pharmaceutical industry use cloud solutions and
Interview with Vincenzo Giorgini – Rigel Life Sciences
Vincenzo Giorgini spent his first 15 years of professional life in production, 2 years as the head of injectable department and another 13 years as pr
Validation of a cloud system in a regulated environment
In regulated pharmaceutical environments, informatic systems, including systems in Cloud, must comply with 21 CFR Part 11 and EU cGMP Annex 11. Sherpa
Why is Environmental Monitoring important?
Environmental Monitoring is one of the tools pharma companies must use to obtain knowledge of the state of the Contamination Control in manufacturing
Interview with Laia Movilla, Product Specialist at Sherpapharma
Today we interview Laia Movilla, the Product Specialist at Sherpapharma. Laia has a Bachelor’s degree in Biomedical Engineering from the Universitat P
Available
The last concept added to the ALCOA+ principle is Data Availability. This point is a consequence of the previous one (Data Endurance), i.e. data must
Enduring
The third concept recently added to the ALCOA+ principle is Data Endurance. While this concept is also touched on the previous principle (Consistency)
CONSISTENT
The second concept that has been recently added to the ALCOA+ principle is Data Consistency. All data should be chronologically arranged, with time st
Complete
On 2016, documents on Data Integrity and Data Management issued by WHO (World Health Organization Working document QAS/19.819) and the PIC/S (PIC/S, D
Accuracy
Following the series of ALCOA+ publications, it is time to review last concept of classical ALCOA: Accuracy Data. A way to guarantee the accuracy of a
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