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WHAT IS YOUR DOCUMENT CONTROL PROCESS LIKE?

In a regulated environment, the document control process could resemble an obstacle course replete with

pitfalls. For a smoother experience and to ensure compliance, you need effective control in every phase of

the life cycle of every important document.

5 STAGES OF DOCUMENT CONTROL

The process begins with an individual who initiates document creation. As the document goes through these stages,

other people will be involved. Without an effective system, the process could be bumpy and it might jeopardize compliance.

COMMON DOCUMENT CONTROL ISSUESDave Hunter, MasterControl product management director, identified the most common issues in every

phase of the life cycle of a document in a white paper titled 9 Pitfalls to Avoid During the Document

Control Process. These issues are prevalent in life science and other regulated companies.

Read this free white paper and learn how to improve your document control process.

9 PITFALLS TO AVOID DURING THE DOCUMENT CONTROL PROCESS

9 PITFALLS TO AVOID DURING THE DOCUMENT CONTROL PROCESS

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.  

1. TIME-CONSUMING COLLABORATION

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. 

2. PARALYZING DELAYS

When a document revision becomes effective, 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. 

3. GHOST OF REVISIONS PAST

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 separate, so training tasks

related to document changes might fall through the cracks.

Integrate your processes to ensure timely training

on crucial documents. 

4. TRAINING FALLS THROUGH THE CRACKS

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 documented process are in sync. 

 

5. DOCUMENT REVIEW CAN BE NEGLECTED

Sometimes a change that makes perfect sense to

engineering, regulatory, and quality may be next to

impossible from the point of view of manufacturing without

significant changes. Your change control process  should

involve the right people in every change. 

 

6. NOT HAVING THE RIGHT PEOPLE IN EVERY CHANGE

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. 

 

 

7. RELIANCE ON TRIBAL KNOWLEDGE

Finding a document  shouldn’t be like looking for a needle in

a haystack. You want users to be able to search for a

document and find it easily because documents that are

created and approved, but never referenced are of little use.  

 

8. TIME-CONSUMING SEARCH FOR DOCUMENTS

A document retention policy  sounds like a process to keep

documents around for as long as possible. In fact, it’s about

determining when documents can be safely deleted. Your

document control process should support your retention policy

and not clutter your systems.  

 

 

 

9. INEFFECTIVE DOCUMENT RETENTION

HOW TO AVOID COMMON DOCUMENT CONTROL PITFALLSThese problems are worse in organizations that use a paper-based system or a partially electronic system.

If your company faces this situation, switching to a fully automated system  will be a significant step toward

improving your experience and ensuring compliance.  

Read this free white paper and learn how to improve your document control process:  

9 PITFALLS TO AVOID DURING THE DOCUMENT CONTROL PROCESS

©2016 MasterControl Inc. All rights reserved.  

Or for a summary of the whitepaper, view this infographic.