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9 Pitfalls to Avoid During the Document Control Process

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1. TIME CONSUMING Gathering all stakeholders in a room to collaborate is impractical. Sending emails back and forth is inefficient. Those who use a paper-based or hybrid system are at the mercy of these methods. Switch to an electronic system that provides a virtual collaboration space. 2. PARALYZING DELAYS In a manual process, paper documents can be misplaced or they might sit in someone's inbox for days and weeks. An electronic system will automate routing, follow-up, escalation, review, and approval. 7. RELIANCE ON TRIBAL KNOWLEDGE It takes a long time to develop a medicine, medical device or other regulated products, so it's likely that by the time the product is launched, some of the people in the original team have moved on. In a manual process, this means relying mostly on the knowledge of other employees to understand the product's history. Your system should be able to document the history of a product so there is no need to rely on tribal knowledge. 3. GHOST OF REVISIONS PAST When a document revision becomes effec- tive, access to the prior revision should be cut off. In a manual system, the ghost of revisions past continue to haunt users because it's harder to control documents. 4. TRAINING FALLS THROUGH THE CRACKS Most regulated companies are required to train affected personnel on important quality documents. When the document is changed or updated, it might require re-training. In a paper system, document control and training control are sepa- rate, so training tasks related to docu- ment changes might fall through the cracks. Integrate your processes to ensure timely training on crucial docu- ments. 6. NOT HAVING THE RIGHT PEOPLE IN EVERY CHANGE Sometimes a change that makes perfect sense to engineering, regulatory, and quality may be next to impossible from the point of view of manufacturingwithout significant changes. Your change control process should involve the right people in every change. 8. TIME CONSUMING SEARCH FOR DOCUMENTS Finding a document shouldn't be like looking for a needle in a haystack. You want users to be able to search for a docu- ment and find it easily because documents that are created and approved, but never referenced, are of little use. 5. DOCUMENT REVIEW CAN BE NEGLECTED A review is meant to ensure that a document is still applicable and accurate. Many times, processes evolve without the documentation being updated to reflect the change. An effective document control system should ensure that the actual process and the docu- mented process are in sync. 9. INEFFECTIVE DOCUMENT RETENTION A document retention policy sounds like a process to keep docu- ments around for as long as possible. In fact, it's about determin- ing when documents can be safely deleted. Your document control process should support your retention policy and not clutter your systems. 9 Pitfalls To avoid during the document control process

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