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Quality Engineering >> Quality Methodologies

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leinad
Newbie


Reged: 11/02/12
Posts: 3
Contract IT Resources in a Regulated Environment
      #719196 - 11/02/12 07:06 AM

I work in the IT department of a contract research lab that is heavily regulated by the FDA GLP regs. We have a need to be flexible regarding our employee base to meet demand and we don't want to go through cycles of hiring and laying off workers to achieve this flexibility so we have decided to use contract resources to fulfill this need. There is concern from our internal QAU that this may pose a compliance and security risk. The contract employees don't generally have access to any data and our facility has very strong access restrictions that would prevent them from entering an area where data is stored or where the test system is housed. The only place I see an issue is that contract developers need to access the production database to effectively perform their job and this would be the only place where they would have access to data. However, all of our contract and regular employees sign a confidentiality agreement.
I'm curious to see how others in the industry or across industries are dealing with the need to be flexible and how some of the QA folks view the issue I just described. How are your organizations dealing with this? Have any of you run into this same or similar issues with contract resources?

Thanks,

Da


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CPat
Member


Reged: 12/08/09
Posts: 102
Re: Contract IT Resources in a Regulated Environment [Re: leinad]
      #719202 - 11/02/12 08:37 AM

Are your contract employees acting as developers, testers, operations, production support? In my experience, governance committees take the easy way out. If a regulation indicates a person shouldn't have access to salary information, they restrict access from the entire HR database or better yet, to the production environment.

Can your database be configured so that a contractor role only access to what you want? Do they need access to the actual environment, the data or both?

Would the cost of implementing these changes in your environment be justified in the savings from hiring contract employees as opposed to hiring full time employees?

Can you put a dollar amount on any of this? Seeing numbers in a spreadsheet goes a long way.


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leinad
Newbie


Reged: 11/02/12
Posts: 3
Re: Contract IT Resources in a Regulated Environment [Re: CPat]
      #719214 - 11/02/12 10:31 AM

CPat,

Thanks for the response and good questions and suggestions. I will need to see if we can impose those access restrictions.

Our contract employees are developers and project managers.

My concern is more about gathering some information regarding how others in the industry are approaching the need to have contract developers and such in a regulated environment as ammunition for an anticipated shootout with QA:). The regulations don't address this issue at all but I am getting push back from our internal QA on this. I think you propose a good idea by suggesting that we emphasize the savings as justification for the minimal risk we are assuming.


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leinad
Newbie


Reged: 11/02/12
Posts: 3
Re: Contract IT Resources in a Regulated Environment [Re: leinad]
      #719296 - 11/05/12 07:38 AM

Anyone else have any suggestions? I'm very interested in compiling some examples of how this is being addressed in other companies across industries. How are you addressing data/IP security while using contract employees?

If you are kind enough to post in response please indicate your industry, if your company (not interested in company name as I can see a need to keep that confidential) is regulated and if so by which agency is it regulated.

Thanks!

Dan


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