It is well known that quality must be built into a product from the start and cannot be tested in after production is completed. In like manner, computer validation must become an integrated part of the normal business function using computers. GXP International's philosophy for validation consulting is to be an active participant with and mentor to a client's system team in helping them exercise and expand their own proficiency in validation and in integrating validation support into normal ongoing work procedures.
GXP International cannot warrant that clients will pass full FDA inspection based solely on the work performed by GXP International. Regulatory compliance for computerized systems in any operating environment is the sole responsibility of the regulated company. GXP International will, however, at no cost be available by phone and fax to support clients during an inspection and to discuss work performed by GXP International as requested by FDA inspectors.
The scope of GXP International's warranty is the computer validation documentation produced by its consultants. The limit of this warranty is that GXP International consultants will rework and resolve any 483 items or warning letter concerns documented by FDA inspectors on computer validation documentation produced by GXP International under this contract.
The rework/resolution effort will be at no cost to clients for an amount up to 15% of the original contract consulting fees paid. In the unlikely situation that more rework should be required, such work will be performed at the original contracted rate. A copy of the relevant 483 form or warning letter would serve as the rework order.
Should clients desire onsite support during an FDA inspection, the full daily rate plus travel expenses for the consultant will apply.
Dr. Teri Stokes
GXP International
131 Sudbury Road
Concord, MA 01742 USA
Tel: +1-978-287-4393 Fax: +1-978-369-5620
Email: drstokes@gxpinternational.com
Dr. Teri Stokes