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Quality document management system (QDocs)

Working an a laboratory environment, I have a lot of experience with SOP (Standard Operating Procedures) and WKI (WorK Instructions). In the beginning my company was using a paper based system, because the lab was subjected to GLP and thus a computerized system had to be validated and was not easy to find.

Then the new QA offiver decided to create a new electronical system because the need for collecting signatures electronical was getting high since everything was done on paper.

We decided to use WSS as base system and expand it specially for the needs of the lab conform to GLP. WSS is a free system that comes with any windows server edition, so no extra cost.

The system is now going into its 3rd year and is running version 3 now. Each version contained more functionality since the system was such a succes.

In the following posts I will explain the workflows and functionalities of the system. Some technical explanation is also given.

I decided to make a complete new version with the same principles, because my company owns the initial system, I will start from scratch and improve were I can. The first improvement is that I now use content types and its possible to add new document types. 2 default types are SOP and WKI.

Here is a visual overview of the review process, the approval and publishing workflow that automatically follow after the review workflow will be explained in further posts.

 

So QS will initiate the workflow by creating a new Quality document. The reason why QS initiates is that they can perform a check first if the new document is relevant. Also they will decide on the author and responsible reviewer. The responsible reviewer can be the authors direct supervisor or any subject expert. When QS finishes the initiation of the document, an email is sent to the author to tell him about the creation of the document.

The author can start editing the document. When he finishes he can send it to the respobsible reviewer for review. He can approve or disapprove the review. if he disapproves the review, the document will be resended to the author. Whe the RR finishes and approves the review the document advances in the workflow. The last step in the review process is that the QA department does a last check and assignes persons or groups to be instructed in the document. then they release the document for approval. this will be described in a next post.

 The technology used to create this document management system is WSS, .Net, MS SQL 2005 or 2008 and IRM. All Microsoft based products. The custom development consists out of a Sharepoint workflow, several web parts and custom WSS site features. This makes the technology very strong and flexible for future upgrades.