Although document control is an aged-old profession and is widely implemented in various activity sectors, most have difficulty defining it effectively. As digital solutions have advanced so have the capabilities and processes needed to ensure proper document security, analysis, control, and digital storage.

Contrary to common belief, a document does not have to exist in the form of paper or any other hard copy format. Regardless of the media and/or digital solution, your documents are the mechanism used to communicate all requirements and information within an organization.

Requirements or information once captured as a document are subject to the information and document management rules and processes of the organization. All product-related requirements, from the Application Requirements level down, must be properly documented. All administrative requirements, from the Business Regulations level down, must be properly documented.

The types of documents related to products will vary from organization to organization. Several factors will influence the types of documents required such as type of end deliverable, type of industry, applicable regulatory agency, etc. Regardless of the source of the document creation, all product-related documents must be managed through a standard Document Control process.