Akos Bartha, PhD



Akos Bartha, PhD, is a technical and quality adviser, 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