Commercial and Gov’t Pricing Projects at Leading Generic Pharma Co. Our client is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals as well as active pharmaceutical ingredients. Our client is among[...]
Archive for the ‘FDA Computer System Validation’ Category
June 3rd, 2010 - 8:44 pm § in FDA Computer System Validation
Commercial and Gov’t Pricing Projects at Leading Generic Pharma Co.
SQA Solution is looking for QA Analysts with Imany CARS and EDI experience
SQA Solution is looking for QA Analysts with Imany CARS and EDI experience ALL WORK TO BE ONSITE; SQA Solution focuses exclusively on delivering quality assurance, functional automation, performance engineering, and software testing services that support the significant business challenges and deman[...]
July 28th, 2009 - 1:04 am § in FDA Computer System Validation
Multiple PQs by functional area, anyone have experience with this?
Greetings. I have a client that asked about spliting their ERP validation into three seperate OQs, based on functional modules, followed by a PQ for each module tested in a particular OQ. Their goal is to get some of their ERP system back into production ASAP. My thought is that this approach is unu[...]
June 1st, 2009 - 3:08 am § in FDA Computer System Validation
How to validate MD5 check sum hash utility to transfer a file?
Many applications use this utility for validating files or groups of files to show that they have not been tampered with, corrupted or modified in anyway. I am looking to use MD5 to validate File transfer from one RAID to another. Please share your thoughts and opinions, and if you have any articles[...]
April 15th, 2009 - 8:17 pm § in FDA Computer System Validation
What is TEMPO standard?
The Russian TEMP partnership is really promoting GxP knowledge (in collaboration with RASP) in Russsian Federation but doesn’t seem to establish any new or modified standards. And in this site I didn’t find any mentioning of TEMPO standards or change procedures. And in the specification [...]
April 8th, 2009 - 6:42 pm § in FDA Computer System Validation, HP Quality Center
Are handwritten and E-Signatures allowed on the same document??
Hello everyone, I have a question. Is it allowed to use handwritten and E-Signatures on the same document, in terms of Part 11? Are there any restrictions? And if it is allowed, could you please provide me the answer with a reference?[...]
March 30th, 2009 - 6:11 am § in FDA Computer System Validation
What validation documents (IQ, OQ, PQ) are required when a CDMS (Oracle clinical, SAS etc) is purchased from vendor
what validations documents are to be produced when only computer system is installed with Windows XP/Vista, with MS office, adobe and other common software for users?[...]
March 30th, 2009 - 5:56 am § in FDA Computer System Validation
How to determine the extent of Computer validation to be compliant with 21 CFR part 11
The Section “11.10 Controls for closed systems” of 21 CFR part 11states that, (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. The question is How to to determine the extent of validation re[...]
March 27th, 2009 - 10:49 pm § in FDA Computer System Validation
How to audit an application for a pharma company
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