Nicolas,
In my own opinion these are the instances where regulations or regulatory requirements do not "keep up" with the technology and how things are actually done in companies. Your scenario or process is more common with most companies where Purchase Orders (POs) are created in an electronic system. There is not really an "approval" necessarily because the process of actually creating the PO and acceptance of the PO in the system is the approval. Thinking about way some regulations were written are from a previous perspective where POs (and other processes like customer orders) were a hard copy paper that was approved by someone. That PO then was filed in a folder awaiting the product, and once received then would be filed in a filing cabinet somewhere. Now, POs are rarely printed out and all maintained in an ERP system. There are different ways you can show the PO is "approved" through an electronic system, which is described in the associated procedure. As an example, stating in the procedure when the PO is accepted in the system by the person entering the information, then the PO is "approved" which the electronic system should show who created the PO and when. There are some electronic systems/ERP systems do have an approval step in PO generation, but more often than not there is no specific approval. Therefore, ht process should be described when a PO is approved - remember it is about the controls in place ensuring the proper content, requirements, specifications, etc., are included on the PO.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Jan-2020 13:25
From: Nicolas Garrett
Subject: Brazil GMP (ANVISA)
Hi all,
We are performing a gap analysis of the Brazil GMP (ANVISA) for IVDs. The following is required per the standard:
2.5.4. Purchase records. Each manufacturer shall maintain records of purchase orders that clearly describe or make reference to specifications, including quality requirements for components, manufacturing materials, finished products or services requested or contracted. The approval of orders, including the date and manual or electronic signature of the responsible, shall be documented.
Would email approvals being attached to the PO be acceptable as documentation for the approval? Or would an audit log of our purchase order system showing our procurement managers date and name be acceptable? We are trying to add this in easily to our procedure since there are so many POs being produced, it seems burdensome to have to get an approval of every single PO we create.
Any guidance is helpful!
Thanks!
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Nicolas Garrett MS
Regulatory Affairs Associate
Norman OK
United States
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