Document Control

GxP/GMP, GDocP, ISO 9000 and documentation

GxP stands for "Good Practice" which is quality guidelines and regulations. The "x" stands for the various fields, for example Good Documentation Practice or GDocP, Good Financial Practice or GFP and so on. There are many instances of these regulations. One instance of GxP is Good Manufacturing practice or GMP.

GMP describes required Quality Management System (QMS) for manufacturing, testing, and quality assurance in order to ensure that products are safe, pure, and effective. GMP has ultimate goal to enable companies to minimize or eliminate contamination and errors which protects consumers from purchasing a product which is not effective or even dangerous. GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.

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ISO 9001 compliance becomes increasingly important in regulated industries. How does it affect documentation? Here is how...   What is Document Control?   Document control means that the right persons have the current version of the documents they need, while unauthorized persons are prevented from use.   We all handle many documents every day. These documents include forms that we fill out, instructions that we follow, invoices that we enter into the computer system, holiday schedules that we check for the next day off, rate sheets that we use to bill our customers, and many more.   An error on any of these documents could lead to problems. Using an outdated version could lead to problems. Not knowing if we have the latest version or not could lead to problems. Just imagine us setting up a production line to outdated specifications or making strategic decisions based on a wrong financial statement.   ISO 9001 gives us tools (also referred to as "requirements") that show us how to control our documents. Read more

There are few applications specifically designed for document control. Arena is one of them and it is the subject of my today's post.

Arena has the following modules:

• item management;
• Bill of Materials Management (BOM);
• change management;
• supplier collaboration;
• compliance tracking;
• project collaboration.

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Document control is revision control of documents, assigning and tracking documents numbers, change control management, assuring documents compliance, documents routing and tracking. It can also include Bill of Materials (BOM) and Approved Vendor List (AVL) management. Document control could either exist separately or could be a part of content management activities.   In companies, especially in regulated industries, there are document control people for performing document control functions separately. They do not have any functions related to content management. Document control is usually part of QA. It is mandated function in regulated industries. Document control is a part of ISO 9001 and GMP/GxP requirements.   The primary purpose of document control is to ensure that only current documents and not documents that have been superseded are used to perform work and that obsolete versions are removed. Document control also ensures that current documents are approved by the competent and responsible for the specific job persons and are distributed to the places where they are used. Read more

In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are required to use a change control procedure. I am going to describe this change control procedure in this post.   A change control procedure is usually one of standard operating procedures (SOP's). It usually includes a change control form. Some companies also use change request forms for suggested changes. This procedure usually includes the following components:   Identification   The identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material, and any other related item or document. The change control form has blank spaces for recording this data. Read more