In this article, Dr. Jon walks through the document control, SOPs and Good Manufacturing Practices incorporated with the igwLAB from extraktLAB. The IGW software seamlessly integrates with the production process using its Document Control Manager to ensure traceability throughtout the production process and efficient SOP and document management for GMP compliance and overall well structured processing.
Document Control for GMP Compliance
One of the key aspects of GMP is that you have a written documentation and that written documentation is controlled. Usually what they mean when they say control is that changes have traceability to them. So if you have revision one and revision two, or maybe even three and four of that document that has all been recorded, and you know exactly what was changed.
There should also be a process by which you can introduce, maintain and approve changes that take place in those documents.
For example, you can’t have an operator changing the SOP, just because he or she wants to do something differently. You typically would have a document control process in that case. With the igwLAB you have a document control system that makes sure you have all the documents available to the user on the spot that have the right rev numbers assigned to your process, and that they have been approved and signed off on by the quality assurance or quality assurance manager.
Process Tracking with Document Control
What the igwLAB allows you to do is really take those documents that come out of an approved process and make them available at the point of manufacture. This also allows you to warehouse all of the changes that have been made in the right version and add events to those documents. For example, version one, version two, or any other changed document would be recorded as an event, or an uploaded MSDS, that would be an event. So any of your documents, and your SOPs need to be at your actual process, and they need to be the latest and greatest. That’s what the IGW software has to offer.
In order to be GMP compliant, you need to have a piece of paper in the process outside of the IGW that would approve those changes. So the IGW does not, for example, route approvals, it doesn’t really make changes or even do REV edits on the actual text itself – that can be done outside of the IGW software. The sole purpose of the IGW is to provide real time, up to date approved documentation at the point of manufacture and that you can use as an event manager to go back six months, 10 months or even five years ago, so that you have a length of data and say, “these are the documents I was using at that time.” That’s the great thing about the traceability of IGW.
Document Control Interface
Now we’re taking a look at the document control interface. On the left hand side, there’s a document control module which has a variety of options. You can search for different documents, you can assign different documents to different facilities and you can even sort by date modified. This is important in the event that you have a significantly older document or the documents entered get completely filled up.
Let’s get into the different documents. The documents that we have here can be implemented with permissions and controls that allow for traceability throughout a production. If I have a receiving inspection SOP in the IGW software, I can take it and add an action to that. Now, there are permission controls on what an employee can do. You have to be a quality assurance manager or an operations manager to really make those document changes. This allows for traceability and quality management from management down to each individual employee.
If you’ve been uploading files, for example, if you wanted to have a new file put in there, I can add that on their production record. Then I can select the categories for that documentation as an SOP, add it to that document, and assign the document to specific locations. Like the inventory vault, the extraction room and any other location in your process. The efficiency of this document control also depends on how your facility is laid out in particular.
At any point now I can add in a completely different document, assign it for any process point I want. Take SOP for milling, for example. After I create and assign the document I can add categories to it. In this case, it’s an SOP, it’s going to be at this facility and it will be in the milling room. I can easily assign those categories to this new document specifically for a milling SOP with just a few buttons.
Assigning and Registering Documents
So the new document has been created, it’s all uploaded, I assigned it to these particular locations, and I selected those categories. Now I can go back to managing my documents with the Document Manager. Suppose I want to change a registered event to any particular SOP. With the Document Manager, you can see all your data with an SOP, collect all your data, delete documents and files, or add in a different file. This makes document control incredibly streamlined inside of the igwLAB.
So that’s the document module. I hope you enjoyed it, and I’m looking forward to doing more of these modules with you guys so you can get a better understanding about what is required for your SOPs and what is required for your process to bring them to your production facility and maintaining control over those either productions. So this has been Dr. Jon Thompson with extraktlab, I hope all is well with you. Thank you, Take care.