Karin Östergren, M.Sc.

Karin Östergren, M.Sc., is the manager for Quality Assurance Computerized Systems, AstraZeneca Sweden Operations, S-151 85 Södertälje, Sweden.


Upgrading a Pharmaceutical Laboratory to Part 11 Compliance

FDA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1