Controlled Document

 A controlled document is a document that has been formally reviewed, approved, and issued by an authorized person or organization, and is subject to change control procedures. In regulated industries such as pharmaceuticals, medical devices, and biotechnology, controlled documents are critical for ensuring product quality and regulatory compliance.

Controlled documents may include standard operating procedures (SOPs), batch records, specifications, test methods, and other quality-related documents that are essential for product manufacturing, testing, and release. These documents are typically subject to revision control procedures, which ensure that changes are properly reviewed, approved, and communicated to all relevant parties.

Controlled documents typically include the following features:

  1. Document number and revision history: A unique identification number and a record of all previous revisions.

  2. Document title and purpose: A clear title that describes the content and purpose of the document.

  3. Approval signatures and dates: The signatures and dates of all personnel who reviewed, approved, and issued the document.

  4. Effective date: The date from which the document is effective.

  5. Distribution list: A list of all individuals or departments who are authorized to access the document.

Controlled documents are essential for maintaining consistent product quality, ensuring regulatory compliance, and facilitating effective communication and training within an organization.

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