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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 ISSUES

Dave 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 P IT FA L L S T O AVO I D DU R I N G T H E D O C U M E N T
C O N T R O L P R O C E SS

9 PITFALLS TO AVOID DURING THE DOCUMENT

CONTROL PROCESS

1. TIME-CONSUMING
COLLABORATION

Gathering all stakeholders in a room to collaborate is impractical.

Sending emails back and forth is inefficient. Those who use a paperbased 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 someones inbox for days and weeks. An
electronic system will automate routing, follow-up, escalation,
review, and approval.

3. GHOST OF REVISIONS PAST

When a document revisionbecomes effective, access to
the prior revision should be cut off. In a manual system, the
ghost of revisions past continue to haunt users because its
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 separate, so training tasks
related to document changes might fall through the cracks.
Integrate your processes to ensure timely training
on crucial documents.

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 documented process are in sync.

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 manufacturing without
significant changes. Your change control process should
involve the right people in every change.

7. RELIANCE ON TRIBAL
KNOWLEDGE
It takes a long time to develop a medicine, medical device or other re
gulated products
, so its 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 products history. Your system
should be able to document the history of a productso there is no
need to rely on tribal knowledge.

8. TIME-CONSUMING
SEARCH FOR DOCUMENTS
Finding a document shouldnt 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.

9. INEFFECTIVE DOCUMENT
RETENTION
A document retention policy sounds like a process to keep
documents around for as long as possible. In fact, its about
determining when documents can be safely deleted. Your
document control process should support your retention policy
and not clutter your systems.

HOW TO AVOID COMMON

DOCUMENT CONTROL
PITFALLS
These 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

Or for a summary of the whitepaper, view this

infographic.

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