Category Archive for FDA Computer System Validation

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 demands of our customers. Our experience and capabilities are extensive and reach into most major vertical industries. We are looking for QA Analysts with Imany CARS and EDI experience to join our team in San Francisco, CA

* 7+ years experience as a QA Engineer in software development technical organizations.
* Experience testing-Many’s CARS applications.
* Strong troubleshooting skills on n-tier applications.
* Experience with applications that support order and contract management organizations.
* Experience with I-Many product line highly desirable including CARS, Medicaid, GP including New Generation line of products like Contract Authoring and Validata
* Strong data validation using SQL; complex query development (inner/outer joins).
* Strong understanding of testing message types; EDI and XML messages.
* Excellent communication skills and strong experience working in an engineering team.
* Experience testing java based applications, Oracle Database and UNIX OS.

MOST CRITICAL SKILLS: Knowledge of i-Many’s CARS , EDI.. Excellent knowledge of Oracle, Linux, JBoss, Apache is a major plus.

Send resumes to fuad@sqasolution.com

About SQA Solution
SQA Solution Inc. is a provider of On Demand software testing , Our US based and global professionals with proven methodologies serve as software testing partner throughout a client’s product implementation schedule. Our clients rely on SQA Solution services to deliver quality and bug free software to their customers. Based in San Francisco, California SQA Solution maintains offices in India and Ukraine providing services under the SQA Solution name. To learn more about the SQA Solution team, visit http://www.SQASolution.com
About The Author:
Fuad Mak – Co Founder and Test Architect at SQA Solution . SQA Solution is an SEI – CMM Level 4, ISO – 9001:2000; ISO – 27001 Certified, 20+ people Software Testing Company. We have been providing services since 2001. Contact us for more detail: Fuad Mak – fuad@sqasolution.com

http://www.sqasolution.com

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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 unusual, but could be used as long as there is a “true” PQ of the entire system at the end, just like any other validation.

If anyone has experience or a comment on this approach, it would be greatly apprciated.

Posted 8 hours ago

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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 that would be useful as well.

This is simply an idea that I am exploring the merits of and I was wondering if anyone has used it. I am mostly interested in .

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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 for the position I mentioned before it so directly required as a crucial skill: a candidate should be an expert in TEMPO change request procedure. Looks like some internal document management and/or workflow management system/methodology.

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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?

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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?

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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 required to be compliant with 21 CFR part 11. Is it the full validation required or only the validation of features which are required for intended use.

I like to put my query with a basic example of simple Computer system validation. Is it necessary to validate all the hardware and software in the Computer to be compliant with the 21 CFR part 11 or only the intended hardware and software validation will serve the purpose of achieving the compliance of 21 CFR part 11.

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How to audit an application for a pharma company

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