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Aug 1

ISO 9001 and Documentation

ISO 9001 and Documentation
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 Using an outdated version could lead to problems.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 Just imagine us setting up a production line to outdated specifications or making strategic decisions based on a wrong financial statement.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.

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Jun 19

Document Control Systems Reviews - Arena

Document Control Systems Reviews - Arena

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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May 15

Document Control System Implementation

Document Control System Implementation
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.

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Categories: Document Control
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Feb 16

Change Control in the Regulated Industries

Change Control in the Regulated Industries
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.

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Feb 15

Change Control

Change Control
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.
 
The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.
 
Change control is used in a wide variety of products and systems. For Information Technology (IT), it is a major aspect of the broader discipline of change management. Typical examples from the computer and network environments are patches to software products, installation of new operating systems, upgrades to network routing tables, or changes to the electrical power systems supporting such infrastructure.

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