How To Complete Method Validation Documentation
What Belongs On The First Page?
Whether you have brought on an organization to map your facility, or you are performing the mapping study yourself, you will need to know what the document containing mapping or validation results looks like. While it may seem cliché, the first page of your mapping or validation document is probably the most important.
Now, when we say ”mapping or validation document” we are speaking specifically to the results that your company or a mapping contractor will generate after the mapping is done. If you are preforming a mapping validation yourself, the outline and overall form of this document should have already been created before you placed your first sensor in your facility. If you are hiring a contractor to map your facility, or validate some piece of your cold chain equipment, you should ask to see a sample copy of what they will provide you after the mapping study is complete.
The first page of your mapping or validation results is also known as the “Approval Page.” This first page contains essential information that your auditor will look for when she or he is reviewing your temperature mapping or validation study.
The first thing that this page should have written on it, probably in bold, is the name of the project or study. Usually somewhere at the top, the name should tell you exactly what was done. For example, ”Temperature Mapping Study for the Dickson Company.”
The second piece of information that needs to appear on your approval page, is the contact information of the group who performed the study. If you performed the study, then that’s your company’s name, address, and telephone number. If it was performed by an outside group, you should have not only their company name, address, and telephone number on this page, but the contact information of their project lead as well.
The third piece of crucial text that must appear on your temperature mapping or validation approval page is the make, model, and serial number of the unit being validated or mapped. If an entire warehouse is being mapped (as opposed to a single refrigerator or cold room) then the address of the facility should appear on the approval page as well. Your auditor will want to know that this mapping study was performed on a specific piece of equipment or a specific facility.
Next up, is date(s). Not the date that the document was created, or the date that you received the document from an outside contractor, but the date(s) associated with the mapping or validation study. If the mapping or validation took more than one day to complete (it probably will) then the beginning and end dates of the study should be listed. This piece of information is also referred to as the date executed.
Finally, and most importantly, are signatures. Your approval page should obviously have some signatures on it. The most important signatures are by the people completing the study, and the project lead(s) on your end. In many validation documents, the organization completing the validation study (again, that could very well be you) and your project lead will have initialed signatures and dates on every single page. For the approval page, initials don’t cut it. Printed and signed names with associated dates from the project lead and person performing the validation or mapping study is essential to the proof and legitimacy of the document.