Process Control Systems GAMP 5 Software Categories
In the article Validation Determination the use of categorising software was discussed and how...
ISPE GAMP 5 Software Categories: Hardware & Software
As discussed in ISPE GAMP 5 the GAMP Categories for hardware and software have...
Efficient Software Testing for a Regulated Environment
Testing, as with all validation activities, is not only performed to demonstrate regulatory compliance...
Electronic Records – CSV FDA Warning Letters
In addition, we remain concerned that your (b)(4) adverse drug experience reporting system has...
EU Annex 11 – Computer System Inventory
EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems...
Computer System Validation – Periodic Review
Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer...