Agency Reviewed Documents (second hand pre-used) will now supplement Validation Online's popular range of highly cost effective, interactive Documents. This library will contain specific compliance documentation, which has been authored for, and used in an FDA / MHRA / or other national regulatory authority, regulatory inspection. They will range from the likes of an IQ for a specific type of mixer, to a complete validation suite of documents (URS to PQ) for a specific equipment system.
If you are an author or a validation person, or a company producing regulatory required protocols / method statements / SOP’s / process methods / risk assessments or any other of the multitude of documents the industry uses, than please do not let your agency reviewed documents fade away, on some server or store. There is probably some one in the next town, state or country just about to produce an exact copy of what you may be throwing out.
When we receive documents for resale, we run them through a process that sanitizes them, removing all references to the company of origin, and all traceable elements i.e. personal names, individual company descriptions, trade names, serial numbers, internal document references, etc. All these details along with the identity of the supplying author or company are treated as completely confidential and guaranteed to be secure. The documents, once completely sanitised, are loaded to our secure servers and can only be viewed after purchase.
Validation Online has two levels of commission in these sales, if we do the sanitation we pass on forty percent of the retail price to the document owner. If the document owner undertakes the sanitation (we show how), we pass on fifty percent commission. There are no up front charges.
A lot of document authors are now finding they can augment their salary or sometimes pension quite considerably this way.
We have been in involved in the creation of regulatory required documentation for eighteen years and have sound estimating knowledge of what most documents cost to author from scratch or from templates. So we set commensurate values on all documents.
Individual simply documents may be valued quite lowly, however complex protocols for specialist equipment maybe priced a several hundred dollars, while a complex validation suite ranging from URS to PQ may be valued a several thousand dollars, even higher sums are available in some cases.
Don’t delay, join this cost effective documentation revolution and start building that extra income now.
Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question, you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.