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the inspector online

Volume 5

This issue:

 
Product Feature

The Latest & Greatest in GV Technology

See what more we can do for you.

Our customers ask, we deliver.
We are committed to continuously developing our products to reflect the needs of our customers.

Why should you upgrade?
Good question. Read the details of the new versions to see why.

DOCU-PROOF 3.4.0

FEATURES BENEFITS
Ability to import PDF annotations Verify call-outs to ensure changes were made.
Ability to ignore word order Ability to customize inspections.
Ability to inspect multiple file types (HTML, XML) More flexibility.
Ability to compare multiple masters to one sample More versatile and faster inspections.
Available with Vista & Acrobat 8 Extensive compatibility.

 

DIGITAL-PAGE, TVS, & Scan-TVS 4.4.0

FEATURES BENEFITS
Ability to select & deselect image layers Perfect for graphic files: focus your inspection on specific file details.
Vista Operating System & Oracle 11g Extensive compatibility.

New camera with improved zoom functionality
Inspect the smallest of areas with pixel precision.

 

Single layer inspection at work...




Inspect only what you need to inspect. Get rid of unnecessary layers such as dimensions, titles and borders.


For Gold and Platinum Support Plan Holders:
All releases notes and software can be obtained by contacting the Global Vision Support Center.

Not a support plan holder? Don’t worry, contact us today and we will get you started.
support@globalvisioninc.com

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Customer Spotlight:

The Proof is in the Process

A recent FDA regulation revision has had pharmaceutical packagers scrambling to fine-tune their process. The regulation implies changes to the size and content found on inserts, consequently translating into more complex and time consuming inspections for pharmaceutical packagers. It is now more important than ever for pharmaceutical packagers, such as Catalent, to ensure processes are operating as efficiently as possible.

“Reading an even larger sheet will take more time and larger equipment. Our goal is to reduce the time it takes for verifications in order to increase efficiencies for both our customers and ourselves,” says Maria Serra, QA manager for Catalent Puerto Rico.

Being a Global Vision customer for over a decade, Catalent had already benefitted from Global Vision’s automated inspection solutions in their production department. However, they believed that if they could extend this same technology to all departments in their workflow, they would be able to increase efficiencies even more—regardless of the FDA regulation. “Completely automating our process would allow for quicker verifications, better error detections and a happier QC staff,” says Serra.

Catalent had installed Scan-TVS, a scanner-based artwork comparator, on the production floor many years ago. This enabled them to check the customer proof to the first sample off the press to ensure that they were the same. If they could now also implement it in the prepress department they would be able to support their customers’ efforts to have a completely proofless process. “The goal is for us to demonstrate a solid process so that our customers will trust our QC department enough to give the final go-ahead before starting the full press run. Thus eliminating the need for the customer to physically come to the plant to review and approve the file,” explains Serra.

“Using Digital-Page in our process enabled us to approve a proof within hours as oppose to days.”

Cutting approval time will come in handy for Catalent customers that are dealing with product launches that need to move quickly. “Pfizer has come to see our facility and are looking to approve us as a proofless supplier,” says Serra, “which would allow us to make revisions without hardcopy proofs and consequently help them get their products to market faster.” Catalent has been extremely happy with the results from Global Vision and is looking to extend implementation to other plants across Puerto Rico.


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News Brief:

To Print or Not to Print

There has been debate as to whether or not to continue to provide printed package inserts (PI) with prescription drugs. However, as we are moving into a more technology centered world, should PIs be moving that way as well? Keep reading to find out more about both sides of the issue.

In 1998, a committee sanctioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) tried to replace printed PIs with electronic PIs.

Here are some of the main reasons why they believe that PIs should be electronic:

Out of date info.
The information that is provided on the PI is always changing and is almost always out of date by the time it reaches the pharmacy.

Decrease in costs.
Eliminating the need for pharmaceutical manufacturers to print these costly package inserts each and every time they ship a prescription drug.

Ease of use.
Claims have been made that electronic PIs will be easier for health professionals to use.

 

On the other side of the fence are those vying to keep the hardcopy PIs, stating that discontinuing them would be against the best interest of the public for the following reasons:

Access to electronic PIs.
There is no way to completely ensure that everyone will have access to the electronic formats. What about the elderly? What about power outages?

The right to choose.
There is plenty of information online for those that prefer to obtain drug information that way. In keeping the printed PI, all parties will remain happy.

Responsibility to the public.
The FDA is responsible for ensuring that those that dispense prescription drugs to consumers have all the necessary information pertaining to proper usage, side effects and cautions. The way they do that now is through ensuring that each provider receives printed PIs detailing all this information. If printed PIs are eliminated, there will be no way for the FDA to monitor the distribution of this information.

Additional Issues.
Switching to an environment that deals strictly with electronic based PIs minimizes the FDA’s ability to properly monitor validation protocols, equipment maintenance and backup systems.

Small costs, big payoffs.
The costs associated with printing the PIs are minimal relative to the average price of prescription drugs. Especially when you factor in the assurance and security that is provided by printed PIs.

As it remains now, for most prescription drugs, there is no guarantee that consumers will get any information with the medication that they are given. Printed PIs are seen as an easy, fool proof way to ensure patient safety and minimize risks. However, others think that we should be moving with the times into the world of online PIs. Whatever the verdict, it is important for Congress and the FDA to install measures to keep consumers safe, whether it be through electronic or printed packaging inserts.

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For our Customers:

Global Vision Announces Partnership with Indian Representative

Global Vision is happy to introduce a new international reseller to their team. Based in Mumbai, India, they specialize in delivering material testing instruments to clients from around the world.

“We are extremely pleased to now be able to offer Global Vision’s automated inspection systems to our clients,” says the company's Director. “They have been the leader in the automated inspection world for quite some time now and it is an honor to add their solutions to our existing product line.”

“The demand for automated inspection solutions has been quickly increasing in India,” says Global Vision President, Reuben Malz. “It is our job to make sure that all of our current and future Indian customers are well supported from the get go. We are confident that they have the expertise and ability to properly represent Global Vision in India.”

 


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