Below learn about the List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy) and the difference between Controlled documents and uncontrolled Documents used in the Pharmaceutical documents system.
Types of Document Copies in Pharmaceuticals:
Master Documents:
The originally approved copy of a document Is marked as a “MASTER COPY” stamp on the Front/Back side of the page with Blue Color ink & kept in a file marked as “MASTER COPY” is called a master copy and is retained in the custody.
Controlled Documents:
Photostat/copy of master copy for departmental/user uses It is stamped in Red ink as “CONTROLLED COPY” on the front of the page is a controlled copy. Controlled copies are distributed as per distribution lists.
Obsolete Documents:
A copy, that has been revised, withdrawn, or superseded, is called an obsolete copy’. It is stamped in Red ink as “OBSOLETE COPY” on the front of the page and is an Obsolete copy Its hard copy is destroyed and its soft copy is retained in the computer’s respective folder with the old revision number marked at the end of the file name.
What is Documents Control?
Have you ever wondered if a document you found is the latest one? Or question if it’s really accurate and up-to-date? Below is an explanation about Document Control and how it helps you trust the documents you work with.
Document Control aims to make sure documents can be trusted by users. It ensures reliable, updated, checked, and officially approved information. It also keeps records of how documents are produced, exchanged, and changed.
So, what is Document Control? It’s a profession that manages documents. Its job is to enforce specific processes for creating, reviewing, modifying, issuing, distributing, and accessing documents.
You’ll find Document Control in many sectors, and it’s crucial for any organization. It’s a vital part of managing risks.
Remember, Document Control isn’t the same as software like Electronic Document Management or Content Management Software. Those are just tools for Document Controllers.
In short, document controllers are pros who ensure documents are accurate, reliable, and trustworthy at every stage. They minimize risks for their organizations and build trust in the documents available to users.
Related:
Controlled Documents Vs. Uncontrolled Documents
We’re comparing controlled documents to uncontrolled ones. What exactly is a controlled document? Put simply, it’s a document that needs to go through specific Document Control processes.
A controlled document follows a formal review, approval, distribution, modification, storage, and access processes. Document Controllers manage these processes. Being a Document Controller requires both theoretical and practical knowledge.
Now, let’s discuss uncontrolled documents. Essentially, these are documents not managed in the Document Control sense. They raise risks for the company and individuals within it. Uncontrolled documents pose threats to safety, compliance, traceability, correctness, information loss, confidentiality, and reputation.
Controlled documents mean trust, lower risks, efficiency, compliance, and traceability. To shift from uncontrolled to controlled documents, proper Document Control practices must be implemented, acting as a gatekeeper.
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Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has experience in Pharma manufacturing and has worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don’t hesitate to reach out via email at [email protected].