Checking the Fine Print – Bayer HealthCare Partners With CIS

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As FDA tightens controls over the accuracy of labeling content, drug makers continue to respond with more-thorough means of checking all packaging components. Still, consumers and the legal system demand more 100% accountability for even the most minute of errors. Something as minor as a missed hyphen can turn a 1/2 tablet dosage into a 1.2 tablet dosage, a potentially dangerous oversight. To avoid such mistakes, current GMPs require 200% human inspection. However, even with this 200% inspection policy, labeling mistakes and omissions remain the largest reason for recalls.

Moving beyond human inspection, Bayer HealthCare (Morristown, NJ) has taken the lead by automating the proofreading process for its printed materials. The firm has partnered with Complete Inspection Systems, Inc. (CIS; Indialantic, FL). Complete Inspection Systems, Inc. has created a new proofreading system designed to cover a full range of visual inspection tasks. Its flagship product, AutoProof Pro, is designed to locate any labeling problems from first draft through the final production process. AutoProof Pro is a suite of tightly integrated tools that work together to ensure the accuracy of day-to-day quality-assurance tasks. The software is designed to run on standard office computers and peripherals, so the system can be shared between publishing, printing, and production services.

Labeling control manager Terry Cullen, along with system operators Karen Kunkle and Linda Lynch, who handle graphics and materials for a number of Bayer plants, championed Bayer’s proofreading project. Bayer decided to incorporate AutoProof Pro into its label control department to act as the quality control tool throughout the entire process. Bayer’s user requirement specifications included ensuring that operators could automatically inspect and compare text at each step of the process.

For instance, after the original printed regulatory material is created and submitted to FDA, it is often revised. After FDA approval, it is then sent to the graphics department so that artwork can be created for the product. The regulatory document is then compared against the insert, label, or carton. Such proofing can be very difficult, as the formatting, character size, style, and number of words per row may not even match. Multiple languages, graphs, charts, and images are also often used, further increasing the chances of proofreading errors.

To assist Bayer with these tasks, Complete Inspection Systems, Inc. two reading and inspection modules. The first, called the PDF Text Extractor, gives Bayer the ability to convert almost any electronic file to a PDF format. The user can then select or zone an area and compare it with 100% accuracy to other documents in almost any language supported by Unicode standards. The operator saves the extracted text for use with the AutoProof Pro Text Compare Module.

The operator can then take the finished insert, convert it to a PDF, read it, and save it as a text file as well. The operator can then go to the AutoProof Pro main menu, select the Text Compare icon, and load the regulatory document and the finished insert. The Text Compare function locates each character and aligns it as closely as possible to the other document. Any characters found on one document but not on the other are highlighted. In less than 5 seconds, AutoProof Pro highlights any differences in the two files.

Using AutoProof Pro, Bayer can automatically proofread material from the earliest stages of production to the final product. AutoProof Pro validates documents even if they have been reformatted, exported to other applications, or even authored on different operating systems. To inspect printed materials, AutoProof Pro uses advanced visual comparison techniques tuned to pick up even the smallest errors. Printed materials can be scanned using a variety of devices, ranging from desktop scanners to 50-in. sheet feeders. AutoProof Pro compares sample documents with the original approved master, looking for any changes in the written copy, document formatting, graphics, and bar coding, as well as imperfections created by mechanical printing problems. For complete end-to-end product validation, AutoProof Pro can be used to compare packaging components removed directly from production to validate them against a master.

AutoProof Pro was also designed to meet 21 CFR Part 11 standards.

QuantumCompare Document Inspection for Packaging and Inserts

Complete Inspection Systems, Inc., has announced its advanced new document comparison system. QuantumCompare sets a new standard in digital document comparison; for the first time, two electronic documents can be inspected for content and style differences, regardless of their appearance, layout, authoring, distillation engine or number of pages. Differences are highlighted in the body of the original document, in the precise context in which they are found. Using unique new technology, QuantumCompare analyzes the unique Unicode value of each character, rather than its shape or appearance, making it the most advanced text comparison software on the market today.

QuantumCompare is a user friendly document comparison system for any digital documents in which accuracy is absolutely critical: product information, packaging, manuals, labels and booklets. It is Unicode-based and can read and distill PDF files for comparison from a number of common formats. It is capable of finding differences in font type, font style, text color and can compare other text attributes like bolding and italicization.  To begin a comparison, the user loads the master and sample documents into the system, and selects the regions to be compared (or selects nothing, in order to compare the entire document). Next, the operator executes the comparison – the computer will compile the words present in the two files and compare their underlying data values, as well as the attribute tags such as font, bolding, italics, color and size. The system will then report back the results to the operator. In the example here, among other errors, the word “linearly” was left out of the sample – the system reports the change as a deleted word. A word present in the master file was left out of the sample and hence the word is deleted. The change is highlighted in the document in the original context and the difference is listed in the Difference Navigator along with the type of difference.

Detected errors are identified, aligned and color-coded the Difference Navigator pane. Errors are reported in the same order as they appear within the document, allowing the operator to read and revise sequentially. Use Quantum Compare to check your documents after each revision to verify that only intentional changes were made. What was changed? What is the precise nature of the change? Quantum Compare will give details about how and where the change occurred, and can generate a detailed report of discrepancies.

MultiCheck all Inclusive Vision Inspection Solution

Complete Inspection Systems, Inc., an automated vision systems manufacturer, has launched its newest quality assurance and inspection system, Multicheck.

MultiCheck  is an all inclusive image inspection solution, with the ability to verify 100% of the copy and graphics on labels, cartons, and other materials by performing image comparisons, text comparisons, reading and verifying the barcodes as well as performing Optical Character Recognition (OCR) on documents and applications with variable information such as clinical trial labels.

The MultiCheck  system is designed for those users whose needs exceed the basic requirements of inspection and designed specifically to proofread labels, inserts and cartons with variable information, as is often the case in clinical trials.  MultiCheck  also has a database component, so that the master documents can be cataloged, with their inspection types and zones already set.

The MultiCheck system consists of a computer and an imaging workstation with a 12 megapixel camera, and a powerful software suite. The system can capture a high-resolution, shadow-free image of any object up to 17 x 23 inches in diameter, under uniform lighting conditions. The camera has built in zoom and macro features so that all objects can be clearly captured.

HD Barcode Secure Identification of Product or Person

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Complete Inspection Systems, Inc. has introduced the world’s most advanced 2D barcode for absolute identification without Internet lookup.

The HD Barcode is a revolution in data density, holding up to 703kB of secure, encrypted information that can be customized with unique private versions of the HD Barcode. Additional security features include a code generator program that is kept separate from the readers ensuring that the barcode can never be reproduced.

As a second security measure, the code can contain data about other covert features and their locations within the identification card. This information can be easily moved as required and only the company has access to that information.

Complete Inspection Systems, Inc. also provides Android or iOS Smartphone apps that can read the HD Barcode and provide conclusive data in the form of images and secure information that would reveal diversion or detect copying of the identification card.

Q-Spec™ End of Line Inspection for Inserts, Cartons and Kit Components

Complete Inspection Systems, Inc. is proud to introduce the newest Vision/Barcode based inspection system Q-Spec™.

Q-Spec™ is a kit verification system designed to inspect and verify all of your labeled components, including inserts, cartons, or other kit components during your final packaging assembly. The system can be custom configured to match your kit against your work order or database.  No barcode, no problem, we can use HD camera based technology to read and match your product code utilizing Optical Character Recognition (OCR) or Optical Character Verification (OCV) technology. Q-Spec™ can be configured to read both the work order and component to eliminate errors by typing in the data. Q-Spec™ provides an accurate and detailed report of any differences found by part number or the expected kits shipped. The system can be configured to require correct flow of the packaging of each kit as well as adding extra or defective components or labels not used. Optional features, such as seal inspection of pouches, product count, or verifying barcodes meet ANSI standards may be added.

Q-Spec™ allows the user to only inspect a random sample of the kits or products being assembled and packaged.

Complete Inspection Systems, Inc. Unveils New 2D Barcode

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Complete Inspection Systems, Inc. has unveiled a new 2D barcode for product identification and brand protection.

The new HD Barcode avoids additional cost to the manufacturing process by being incorporated into printed materials such as cartons, labels or containers, allowing products to be identified instantly and securely from any location. The barcode can be custom-configured to provide each manufacturer a unique private version of the code and holds up to 703k of secure, encrypted information.

A separate code generator programme can be added as an additional security feature to the normal printing process, which is detached from the readers to ensure that it cannot be reproduced. Data pertaining to other covert features and their locations on the materials are also available within the code. In addition, the HD Barcode helps to print the entire insert or directions. We offer an Android or iOS smartphone application that can provide conclusive data in the form of images and secure ePedigree information, by reading the code. The information reveals diversion or detect wholesale copying of the packaging.

Complete Inspection Systems, Inc. incorporates the latest computer, imaging and scanning technologies with its custom software to offer advanced systems and solutions that will meet the requirements within the packaging, medical device, and pharmaceutical industries.

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