Many regulated companies take the option of using Vendor-Provided Qualification Packages.
Is this a good option?
We have found that the quality of the qualification offering varies significantly, in some cases it may not satisfy the requirements of the EU guidance. Some vendors provide excellent documentation which is compliant with the guidance.
The cost of the qualification offerings varies significantly as well. We have seen a client pay £25k for a sub-standard qualification of a single item of equipment which we had to re-write (for a lot less then £25k!).
So here are some tips and guides to help you determine the best option:
• Ask for example documents, be wary if these are not forthcoming
• Get a comparison price from a company such as ours
• Remember risk management is an important element
• Vendor supplied qualification must be reviewed, and where necessary supplemented and approved by the regulated company
• Understand your critical process parameters and how the system will support them, so they are adequately challenged
• Protocols too generic
• Not approving the supplier in site’s QMS
• No specific link to usage of system
• Failure to challenge critical aspects of the system
• Non-compliance with Annex 15
• Poor translation from original language
• Too expensive!
Call us on 07774354446 for advice or to discuss this subject further.