Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
NQA-USA
NQA-USA
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
Forum Username

Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
clia - clinical laboratory improvement amendments, lims (lab information management system), software validation, validation (general), gcp (good clinical practices) for drugs and medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 23rd July 2009, 01:54 PM
erikam erikam is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2009
Location: Orange County, CA USA
 
Posts: 6
Thanks Given to Others: 1
Thanked 0 Times in 0 Posts
Karma Power: 22
Karma: 10
erikam has less than 100 Karma points so far.
Question Validation of new LIMS (Laboratory Information Management System)

I work for a small clinical lab (aprox 20 lab techs) who has previously been subjected to CLIA rather than FDA regulations. As such, we have not validated our LIMS (Lab info management system) which tracks and creates our patient reports. My company recently decided to start accepting samples for pharmaceutical companies for clinical trial purposes, so I am implementing GCP for the lab. Obviously, we need to get our old (but still in use) LIMS validated, as well as the new one which is currently being debugged, and not yet iimplemented. The new system does have electronic signatures and is suposidly complient. I was not here when the decision was made to purchase the software.

My background is in QA and Regulatory Affairs not IT, and I'm not sure how to go about getting this validation accomplished. Is this something we can hire a consultant to do for us, or is it something the IT manager who is implementing the LIMS should be doing?

Thanks is advance, this area of software validtion is new to me and to my company and I really appreciate any guidence any of you have.

Sponsored Links
  #2  
Old 23rd July 2009, 01:57 PM
erikam erikam is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2009
Location: Orange County, CA USA
 
Posts: 6
Thanks Given to Others: 1
Thanked 0 Times in 0 Posts
Karma Power: 22
Karma: 10
erikam has less than 100 Karma points so far.
Re: Validation of new LIMS

oh, one other thing I forgot,

The IT manager is wanting to do very minimal duplication between systems when rolling out the new software. He wants to roll out the software prior to validation, and with only a few weeks of duplication. I am against this, but need to know what other groups do prior to the roll out so I can give the management team a better reason for why an extended test period is a necessity.
Sponsored Links

  #3  
Old 24th July 2009, 04:42 PM
yodon yodon is offline
Appreciated Information Resource

 
Registration Date: Jun 2005
Location: Plano, TX
Age: 55
 
Posts: 726
Thanks Given to Others: 447
Thanked 458 Times in 322 Posts
Karma Power: 120
Karma: 4712
yodon is appreciated, and has over 1700 Karma points.
yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.yodon is appreciated, and has over 1700 Karma points.
Re: Validation of new LIMS

You can absolutely contract validation out otherwise I'd be looking for gainful employment. ;-)

Start with a validation master plan. Decide what all needs to be validated and any general approaches you plan to take to validation. In parallel, develop requirements specification(s) for the software. You have to know what it's expected to do, what regulatory constraints there are (HIPAA?, part 11), security (both usage access & data control), etc. Ensure the software is locally under proper configuration control, ensure your software vendor adequately manages the software, develop the test protocols based on the requirements, run them, record the results, and viola! you're done.

Indeed, this is why many companies contract this stuff out. Having expert support really does save time and money in the long run, IMO (but maybe I'm biased).
Thanks to yodon for your informative Post and/or Attachment!
  #4  
Old 25th July 2009, 12:36 AM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
Forum Administrator

 
Registration Date: Dec 2005
Location: Massachusetts, USA
Age: 51
 
Posts: 5,720
Thanks Given to Others: 1,784
Thanked 2,711 Times in 1,694 Posts
Karma Power: 400
Karma: 16401
Ajit Basrur is appreciated, and has over 1700 Karma points.
Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.
Re: Validation of new LIMS (Lab info management system)

My friend , yodon is right and I would also approach in a similar way. Most organizations contract this activity outside as this involves lot of expertise which our regular IT folks may not be having. Besides, the Computer System Validation (CSV) is a very dynamic area and the experts in this domain are abreast of all changes.

So, my suggestion would be hire a consultant or get in touch with the LIMS software supplier to provide guidance on validation

__________________

You canít use up creativity. The more you use, the more you have Ė Maya Angelou
  #5  
Old 28th July 2009, 12:43 PM
alex.Kennedy alex.Kennedy is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2009
 
Posts: 53
Thanks Given to Others: 0
Thanked 27 Times in 18 Posts
Karma Power: 27
Karma: 172
alex.Kennedy is appreciated, and has over 100 Karma points.alex.Kennedy is appreciated, and has over 100 Karma points.
Re: Validation of new LIMS (Lab info management system)

Good day Erikam

This process can be carried out by yourselves or an outside contractor. I would suggest that you start the process yourselves and define your basic requirements, by raising a User Requirements Specification (URS) and in it document what your end users want the LIMS system to do.

Follow this by executing a Risk Assessment against these requirements to define the seriousness of any default condition.

This will enable you to document a justification for the depth and scope of the validation you undertake. Once these two tasks are in progress, you should raise your Validation Plan (VP). In which you can detail all responsibilities, methods and requirements, that are essential to the compliant qualification of these LIMS systems.

At this stage you will be able to judge what can be done with in-house resources, and what requires external assistance. You will also be able to scope the subcontract work.

We have a free SOP on Equipment Validation, if you can post your email address I will send you a copy.

Alex Kennedy
  #6  
Old 28th July 2009, 12:52 PM
erikam erikam is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2009
Location: Orange County, CA USA
 
Posts: 6
Thanks Given to Others: 1
Thanked 0 Times in 0 Posts
Karma Power: 22
Karma: 10
erikam has less than 100 Karma points so far.
Re: Validation of new LIMS (Lab info management system)

Thank you all for your advice. I think we are going to contract this out. The IT Manager "has all this information in his head" and extracting that information would be easier for a knowledgeable outsider.

Our consultant is going to develop an IT validation policy, create a validation plan for the old and new Lab info systems, develop change control documentation, and assist in conducting a retrospective vendor audit.

Thanks again, you gave me a great starting point in figuring out what to do!
  #7  
Old 9th November 2011, 10:26 PM
yarina yarina is offline
Involved in Discussions

 
Registration Date: Feb 2011
Location: Tianjin PRC
 
Posts: 22
Thanks Given to Others: 13
Thanked 1 Time in 1 Post
Karma Power: 18
Karma: 15
yarina has less than 100 Karma points so far.
Re: Validation of new LIMS (Lab info management system)

Quote:
In Reply to Parent Post by erikam View Post

I work for a small clinical lab (aprox 20 lab techs) who has previously been subjected to CLIA rather than FDA regulations. As such, we have not validated our LIMS (Lab info management system) which tracks and creates our patient reports. My company recently decided to start accepting samples for pharmaceutical companies for clinical trial purposes, so I am implementing GCP for the lab. Obviously, we need to get our old (but still in use) LIMS validated, as well as the new one which is currently being debugged, and not yet iimplemented. The new system does have electronic signatures and is suposidly complient. I was not here when the decision was made to purchase the software.

My background is in QA and Regulatory Affairs not IT, and I'm not sure how to go about getting this validation accomplished. Is this something we can hire a consultant to do for us, or is it something the IT manager who is implementing the LIMS should be doing?

Thanks is advance, this area of software validtion is new to me and to my company and I really appreciate any guidence any of you have.
Dear Erikam,
Since you work for a clinical lab, you must be knowlegable on the CLIA.
If my facility only perform waived tests, I have to obtain Certificate of Waiver, pay biennial certificate fees, and follow manufacturers' test instructions.
Will you please tell me (1) how to obtain CW; (2)how to pay biennial certificate fee; and (3) if the distributor is changed, do I have to send this information to FDA ?

Thanks and kind regards,
  #8  
Old 10th November 2011, 06:51 AM
alex.Kennedy alex.Kennedy is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2009
 
Posts: 53
Thanks Given to Others: 0
Thanked 27 Times in 18 Posts
Karma Power: 27
Karma: 172
alex.Kennedy is appreciated, and has over 100 Karma points.alex.Kennedy is appreciated, and has over 100 Karma points.
Re: Validation of new LIMS (Laboratory Information Management System)

Your first task is to get your LIMs system validated. Go onto the internet and search on 'software qualification documentation'.

Then choose a qualification documentation package that includes all the required documents from VMP to PQ. Ensure that you choose an interactive package then you will only have to follow the interactive instruction to complete the documentation completion.

It is not difficult and can be executed by a reasonably competent technician.

Regards
Ale Kennedy
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
ISMS (Information Security Management System) Implementation Guide keres ISO/IEC 27000 Series - Information Security Management Systems (ISMS) 12 17th October 2011 06:39 AM
Toyota FMDS (Floor Management Developmental System) - Need more Information bpillar Manufacturing and Related Processes 3 20th September 2011 09:44 AM
Appropriate Processes for Information Security Management System (ISMS) Gourmet ISO/IEC 27000 Series - Information Security Management Systems (ISMS) 7 8th February 2011 01:05 AM
Excel Spreadsheet Validation for Calculating Data coming from our Instruments (LIMS) JudyJ ISO 17025 and related Metrology Topics - Measurement Devices, Calibration and Test Laboratories 3 18th November 2010 12:14 PM



The time now is 07:45 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".