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System / Vendor Selection

Which vendors receive the URS?

The URS is sent to some of the vendors. These should be pre-selected according to your basic requirements for modules in the system, operating system and/or database they are using, their technical requirements to clients and servers, etc.

Assessing the answers

The vendors will answer the URS, and will state which requirements they can fulfill and which they cannot. You need to evaluate which are important (need-to-have) and which are less important (nice-to-have). The answers should be weighed according to their importance. Hopefully this will distinguish the vendors from each other. You might want to audit the top vendor to see for yourself is the built-in quality is sufficient for your needs. Additionally you may want to see for yourself or ask other users if the system is "User friendly".


Want to know more?

Publications:

Segalstad: Development Qualification: Selecting the right LIMS vendor, European Pharmaceutical Review, Vol. 5 Issue 4 (2000) 58-61 Also published in: American Pharmaceutical Review, Vol. 3, Issue 4 Winter 2000-2001 (84-87)

Segalstad, Florén, Nilsson: Choosing and installing the right LIMS, Scientific Computing World, Issue 39 June 1998, 25-26. (Re-written by the journal's editor without authors' approvals)


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Sub menu Articles and Information: 

21 CFR Part 11

Standards and regulations

Validation Plan

Qualifications

LIMS

User Requirements Specification URS

System selection

Vendor audits

IT project organization

Live system organization 

 



Segalstad Consulting AS
PO Box 15 Kjelsås, 0411 Oslo, Norway * Tel: +47 2223 8005 * Fax: +47 2223 8581 * Email: Siri@Segalstad.com * 

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