Document Control Procedures Manual
Document control refers to the profession and practice of ensuring that approved document management standards are followed for document creation, review, modification, issuance, distribution, and accessibility.
Document Control Procedures Manual
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Document control procedures ensure that the information contained in organizational documents is accurate and up-to-date, is updated regularly and that the proper process for documents updates is followed.
Document control is a specialized function. The document control system used by an organization is a set or collection of procedures that define the various functions that are needed for effective document control. Document control procedures that are based on best practices are standardized, documented in a document control procedure manual, and are then distributed through the organization. In this way, all employees know the exact procedure they have to follow for any type of document that they are working on or need to work on.
For documents that require revision on a periodic or as-needed basis, the document review procedure defines who can initiate or request document revisions, and who makes the actual revisions. The procedure also includes the method to be used for recordings information related to version control such as document owner, revision number, and chronological information such as date of current revision and next review date.
Even though paper-based documents and document control procedures are still used, most modern document control is performed by electronic document management systems (EDMS). This is because of the many benefits offered by electronic document management systems such as:
You can control access to business documents through password protection. Advanced security features will also ensure that your critical digital documents are protected from security breaches and cyber threats.
Modern document control is accomplished through electronic document control software that automates workflows and offers several additional benefits such as ease of storage and access, and improved security.
Having procedures in place ensures that employees are always working with the most up-to-date and relevant data and documents. The prevents a host of problems that could occur due to dealing with obsolete documents.
Your organization will need to comply with various local, state, and federal laws and regulations. A document control system that incorporates relevant legal and regulatory requirements will help you comply with those laws and regulations.
Disaster Recovery: use of plans and processes that ensure business continuity in the event of natural or man-made disasters. In the context of document control, it usually means maintaining multiple copies of the document repository, so that businesses can use backup repositories if the primary repository is in any way compromised.
Version Control: tracking and managing successive versions of the same document. Version control maintains a database of successive versions of documents so that users can refer to previous versions if required.
If you are new to document control management and are looking to learn more, we recommend taking our Technical Writing Certification Course, where you will learn the fundamentals of managing technical documentation.
In most cases, investing in a results-driven quality management system (QMS) or document control system is the mission-critical first step that your life sciences organization should take in securing an effective document control and management process. Additionally, creating a clear document control procedures manual can position the organization for rapid and sustained document management success.
After establishing basic document procedures and requirements, remove all unnecessary or dated documentation. This will help to eliminate clutter and files that could potentially cause liability or risk of compliance infractions.
Document control procedures set the framework for how documents are approved, updated or amended, how changes are tracked, how documents are published (internally or externally), and how documents are made obsolete.
Who creates a document, and how the document is created, are determined by the document control procedure. This can include details on how the document is formatted, how it is named, and other technical details about the document.
How a document is reviewed, who approves a document, and how approvals or modifications are recorded, are all spelled out in the document control procedure. Quality assurance principles require documents be reviewed for accuracy.
After documents become final and approved, they often still need changes in the future. Document control procedures will determine the process for document revisions. The procedures identify who can initiate or request revisions, and who can implement them. Document revision levels, publish date, document owner, and next review date are managed over the lifecycle of the document. Once revisions are drafted, they follow an approval process similar or identical to the initial document review and approval process. The document control procedure also defines how a document will be identified according to its revision.
Once documents are final and approved, the document control procedures define the parameters of how and where a document is published, and who is authorized to have access to it. Publishing requirements may indicate whether the document is available internally or externally, where a document is made available, what security restrictions are on a document, and so on.
In most organizations, an individual or group of individuals are identified as responsible for document control procedures. This includes responsibility for the Document Control Procedures Manual (itself following document control procedures).
Built right into Microsoft Windows Explorer and Microsoft Office, Document Locator makes document management easy to use. Version control, document workflow, paperless scanning, email management, and a full complement of document control features are available in the document management system.
The Aerospace Document Information Control Procedure for AS9100 defines methods and responsibilities for controlling aerospace quality documents used to provide work instructions or set company policy. The document control policy also defines methods for document revision, approval, and distribution. It applies to all quality documents required by the AS 9100 aerospace QMS. (10 pages, 2518 words)
Document Control is responsible for controlling the aerospace Quality Management System manual, all procedures and work instructions related to the QMS, and all internal and external documents required by the QMS.
The Laboratory Manual is a reference manual for ORA laboratory personnel and supporting units. It provides personnel with information on internal policies and procedures to be used for testing consumer products, training laboratory staff, writing reports, safety, research, review of private laboratory reports, court testimony, and other laboratory activities. (Formerly: Laboratory Procedure Manual)
The short answer is that under ISO 9001:2015, a quality manual will not be required. The ISO 9001:2015 standard does not specify requiring a formal quality manual. However, a quality manual can still satisfy the requirement for documented information concerning:
These manuals are part of the protocol for the National Health and Nutrition Examination Survey (NHANES), conducted by the National Center for Health Statistics. Manuals listed below were developed for interviewer and examiner training. These are important references for NHANES as all correct procedures, policies, and standards are comprehensively detailed. Dates on the first page of each manual reflect the most recent revision.
Document control helps you ensure compliance with industry regulations and reinforce quality management within your organization. This hands-on course gives you a test environment to build your own document control procedures, including: process mapping, referencing and amendments. You will also learn how to maintain a document infrastructure and distribute control documents so that they are current and accessible to all stations.
A memo is displayed in the production line of your pharmaceutical company detailing modifications to be made to an existing production process. The memo is a duplicate of information that is kept under controlled specifications elsewhere. Now consider that further changes are made to the controlled document. But, the memo continues to carry obsolete information because it is not controlled. You either start controlling the memo or destroy it immediately!
In another example, the training department of your medical devices company has prepared a revised and updated training module for incoming new employees. Considering the importance attached to such a module, it must be controlled, and every change documented.
EU MDR: The latest medical device regulation applicable to the European Union has many points concerning document control. There is an emphasis on the lifecycle of the product in totality. This includes post-market surveillance, which is the set of activities that your organization will do to collect and evaluate the capabilities gained from your medical device that is already in the market and to identify if any further action needs to be taken.
With document control, your organization will manage all documents throughout their lifecycle. It means that it is a dependable, standardized, and organized way of organizing documents, data, and information.
So, you will have a set of procedures for document control and a person(s) who will be responsible for document control. The content of these procedures is dependent on if you are using an electronic system for tasks such as numbering, versioning, and archiving.
The document control procedure in your organization will also give a detailed explanation of how the prepared document must be reviewed and who are the responsible persons to approve it. Also, how the approvals and modifications should be recorded will be highlighted in the document control procedure. You should be aware that all documents must be reviewed for accuracy before publishing. 041b061a72