Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the most common challenges with cleaning and cleaning validation? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you have any suggestions for a facility to maintain an “inspection-ready” state? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is cleaning and cleaning validation so crucial to the pharmaceutical industry? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Which significance do the PIC/S Guidances have? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Traceability matrix – what is necessary? Must an end user have a traceability matrix, administrate it and validate it? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans What is standard software? Does standard software have to be validated? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to approve hardware and software suppliers formally? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans How should the frequency of QA audits be determined? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Why are there still inconsistencies in the way different national GLP compliance monitoring programmes inspect multi-site studies? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Are Biologicals/GMOs test items or test systems? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Should new OECD Test Guidelines be developed for Biologicals/GMOs? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Which Test Facility “area of expertise” should be used for Biologicals/GMOs? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Would such global archives need to be declared by each test facility to their national GLP compliance monitoring authority? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans If a GLP inspector requests information retained in an archive, can a test facility respond by retrieving electronic records from a company’s global electronic archiving system (physically located in another country)? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans For some national GLP compliance monitoring programmes, it is acceptable to archive electronic data in a primary database with the use of appropriate access rights (i.e. read only permission for the study director / the study staff/QA and full rights for the archivist etc.). For other national programmes, data can be physically transferred to another location or to a storage medium (also with the corresponding access right modifications) for archiving. Are both acceptable? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans How should hosted services (“cloud” computing) and the retention of electronic data be treated in the context of GLP. 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the responsibilities of TF management with respect to support records? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to harmonise retention times for archived records? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Should an IT service provider that offers software as a service be considered a TF and therefore be included in a national GLP compliance monitoring programme? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the responsibilities of a TF when third parties subcontract non-GLP hosting services with data acquisition systems used in GLP studies (e.g. data storage such as “e-archiving as a service”)? What is considered acceptable? If a data centre uses an IT service provider to only provide infrastructure for the data centre (e.g. space, power, controlled environmental conditions, etc.) or hosting servers of a contracted GLP test facility (i.e. access to the GLP data is only possible via the Test Facility), is this data centre considered to be part of the TF (and not a third party)? Would such a data centre need to be part of the test facility audits? 1.57K viewsDrugsPharmaceutical « Previous 1 2 … 249 250 251 252 253 … 283 284 Next » Question and answer is powered by anspress.net
