Man working on compliance with a laptop

Date: January, 2019 | Categoryquality Author: Ryan Szporer


In spite of the term Software Development Lifecycle (SDLC), there aren’t concrete steps to follow when coding. Each case is somewhat different, even if there is one universal truth: Certain standards apply across the board. Data integrity is one such standard.

The Ultimate Software Development Lifecycle Goal

It may not be the ultimate goal, as that would be releasing a functional piece of software. However, as a key consideration of any successful Software Development Lifecycle (SDLC), data integrity is a requirement that must not be ignored. That goes for GlobalVision’s proofreading software, which follows an SDLC approach, too.

The term “data” is relatively straightforward: information collected and potentially used by the application. “Integrity” is, of course, the end result achieved through the process of keeping that data uncorrupted and unchanged. It goes hand in hand with the concept of data security, which is sought after through the act of taking the necessary measures to protect it.

For example, individual lifecycles have proper security precautions built into them and controls added at each step. One precaution would be the act of defining early on the sensitivity of the data a given system will require. As James E. Purcell writes in his paper, “Defining and Understanding Security in the Software Development Life Cycle”, this enables the security needs of the firm to be considered come the time for decisions to be made later on in the process. Failure to do so leads to potentially unforeseen consequences and add-ons and patches after the fact. Almost by definition, those should be the last resorts.

The Software Development Process

Taking the development process one meticulous step at a time is a way to avoid them. As alluded to earlier, there is a variety that can be followed, but, generally speaking, as a list, it looks like the one below:

Analyze and Plan, which should include preliminary risk assessment. Relevant regulations that will come into play should be looked at and a plan of action as to how to address them should be devised. This should be reflected in the resulting software-requirement-specification document that comes out of these two phases.

Design, where whatever needs to be in the software gets included in the design specification document. Depending on the system being designed and compliance considerations, it may end up including failsafes with regard to the database, so it is easily backed up and restored. Furthermore, as a security precaution to protect against data being stolen or corrupted, encryption, if applicable, is identified as a necessity at this stage.

Build the Software, presumably using secure code to eliminate any potential vulnerabilities that may surface.

Test, with regard to all aspects of the software in a thorough, structured fashion. Testing is as universal as it gets and becomes a focal point of a product’s development regardless of the industry. When it comes to software though, aspects like code quality and security testing are just two of many that should be considered here, ideally by a dedicated quality-assurance team.

Unit testing, where the smallest testable parts of an application are verified for bugs and vulnerabilities independently, is also a popular pre-emptive strike against breaches but can be automated. Meanwhile, black-box testing, which places the application under the microscope of a tester who does not look at its internal workings (as if it were in a black box), seeks to test a variety of things, including external database access and the software for data-structure errors.

Deploy or Release, finally. That’s assuming all tests have passed and any security shortcomings that had been documented during the testing phase have been resolved. As part of the final quality checks of the software, further security testing may actually be done.

Maintain and Evaluate, which translates to updating the software via security upgrades and improvements whenever necessary. It turns out, sometimes there are good reasons behind those Apple iPhone updates.

Dispose, as, even in obsolescence, software must be handled with discretion. If the software is in the midst of being replaced, caution must be exercised to ensure any sensitive data is archived securely or disposed of in its entirety.

After all, any SDLC seeks to create software that is useful to the organization. Logically, software that can be superseded by a newer version has outlived that usefulness. By the same token, an application without the appropriate level of security is relatively useless, to begin with.

The Importance of Data Integrity

As a result data integrity becomes increasingly paramount, depending on the industry in which the software will be used. Expensive changes may be called for at a later date by auditors, but that’s only if the organization in question is relatively lucky.

In a worst-case scenario, hackers could find a way in, compromising not just the integrity of the data but the brand equity of the company too. That could cut any software development cycle drastically short. It doesn’t have to be that way, as the above steps show.

Compliance documents under digital proofing for EU regulatory affairs

Date: January, 2019 | CategoryCompliance Author: Ryan Szporer


Regulatory affairs were created to meet a pressing need, regardless of the industry in question.

For example, in pharma, the Biologics Control Act of 1902 was the first legislation to regulate drug quality in the U.S., while American apothecaries date back to colonial times. Of course, medicine as a sheer concept dates back just a couple more years before that, illustrating how much regulatory affairs departments have had to catch up in what can only be considered a short period of time in comparison.

In any case, whether that aforementioned need is in the pharmaceutical (Food and Drug Administration; FDA), energy (Department of Energy; DOE), or financial industry (Securities and Exchange Commission; SEC), the overriding role remains the same.

Regulatory affairs officers liaise with those governing bodies and different departments within the company to ensure the rules in every region in which a company’s products and services are distributed are met.

Proofreading meanwhile plays a critical role in different facets of a regulatory affairs manager’s day-to-day duties.

Automated quality control enables those responsibilities to get handled as efficiently as possible.

The Responsibilities of Regulatory Affairs

Regulatory affairs responsibilities take the primary form of oversight of a product’s life cycle. Through each of the product’s development stages, there are strict rules and guidelines to follow to ensure compliance. Proofing figures in several of these steps:

  • Initial rule/ law changes are lobbied at the state and federal levels.
  • Product/ drug applications are submitted to regulatory bodies.
  • Briefing documents are compiled for the appropriate regulatory agency to review.
  • Packaging copy created by marketing is sent for internal and external approval.
  • Packaging and labeling updates are evaluated.
  • Changes are applied across different product lines whenever necessary.
  • Info is revised (like the drug formulation and dosage in pharma) to extend product life cycles.

In each case, the regulatory affairs department enters into or even drives the file-creation process. It is imperative the text and artwork be 100% accurate from a spelling standpoint and based on what had been approved internally. While this can be accomplished through manual proofreading, i.e., with the naked eye, digital systems have been proven to catch more errors early in the process, cut down on revision cycles, and improve overall efficiency.

Automated Quality Control for Customer Safety and Post-Marketing Compliance

As an offshoot of the aforementioned tasks, the responsibility for getting products to market as fast as possible also falls on the shoulders of regulatory affairs associates and offices. Regulatory and compliance managers and coordinators must ensure products meet all requirements and that the tests to that effect have gone smoothly. Automated quality control solutions lend a helping hand in that regard.

Furthermore, regulatory affairs departments are generally in charge of post-marketing compliance. If safety issues arise after a product has gone to market, regulatory affairs coordinate with the appropriate agencies to issue a recall if necessary. Recalls can relate to possible contamination or issues with the manufacturing process or, yes, even the packaging.

From a packaging standpoint, automated quality control serves as a cover-all by ensuring even the smallest issues like missing or misplaced decimal points in dosage figures get printed properly. In an industry like pharma, such an error could prove to be disastrous and, in a worst-case scenario, lead to consumers taking fatal doses.

There’s only a risk of that happening if the packaging makes it to production. The importance of regulatory affairs departments thus becomes clear, as does the need for an automated quality control solution therein.

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Get your complete guide to meeting FDA labeling requirements here

Take the first step towards error-free content by starting your free trial of GlobalVision

Learn how some of the world’s top pharma companies have cracked the efficiency code with automation

Capitalized letter, checklist, chart and calculator

Date: January, 2019 | CategoryQuality Author: Ryan Szporer


It’s easier to think of an audit trail as a collection of breadcrumbs leading out of the woods.

The Bright Side of Being Audited

Admittedly, the word “audit” gets a bad reputation. It’s usually associated with the unpleasant process of the same name that can be initiated by the U.S. Internal Revenue Service. In actuality, audits are an unavoidable part of life for many corporations in the sense that they can take place not once but multiple times a year. With an audit trail, they don’t have to be nearly as grueling as people have come to expect, though.

For the uninitiated, trails are the lists of transactions or events kept track of to help auditors and, in many ways, those being audited too. Of course, at its most fundamental level, a company’s audit trail does contain financial transactions. However, they can be chronological catalogs of so many more types of events. An audit is simply an investigation of accounts and records in general. They aren’t limited to those of the financial variety.

For example, audits can be key to achieving and maintaining regulatory compliance, which is in turn critical to operating in sectors like pharma. For a company that develops software intended to meet ISO compliance, perhaps for use within that same pharmaceutical industry, regular internal and external audits are to be expected.

External vs. Internal Audits

External audits can either be initiated by the relevant regulatory body (for certification purposes) or even a client that relies on the given software. Take a digital proofreading application for example.

Continuing within pharma, each piece of equipment that enters into a drug’s chain of custody has to be “validated” as meeting pre-determined specifications and attributes. Obviously, software qualifies as equipment in that context. It makes sense that a firm with as much at stake from a quality perspective as a pharmaceutical company would want to get assurances that a piece of equipment on which they rely comes as advertised as being compliant. It’s theoretically similar to how consumers depend on medication and accurate information on its packaging.

In contrast, an internal audit serves as an evaluation of the company’s effectiveness, from risk-management, governance, and process standpoints. As data integrity arguably touches on all three areas, its importance in a corporate environment cannot be understated. In fact, audits specifically aimed at examining data integrity are a real thing.

Benefiting from an Audit Trail

Regardless of the focus of an audit, trials are undeniably critical to their success. And success is what all parties should strive for, whether they’re doing the auditing or being audited. No one wins however unnecessarily hard one becomes to complete.

That’s one of the misconceptions regarding audit trails that is generally associated with the earlier IRS example. Obviously, an audit isn’t exactly something to look forward to, but it can be made less of a headache if all required records have been kept and are easily accessible to the auditors. Automated trails that are easily searchable make smooth audits more of a reality.

Trails are theoretically included in the software as one of many required technical controls that enable users to achieve compliance with 21 CFR Part 11 with the Food and Drug Administration (in the United States; equivalent to Annex 11 in the European Union). Compliance here ensures companies implement good business practices through reliable electronic records, which must be able to be accurately displayed and exported. Here, the audit trail serves to log what changes to application data were made, when, and by whom and be available for review.

Whoever ends up conducting that review, whether it’s an agency or the company itself, the auditor will no doubt thank you as the bigger picture begins to take shape. Identifying the individual trees is key to seeing the forest as a whole, though. Finding your way through can be hard, but an audit trail can clearly reveal the right path to take.

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10 Ways to Improve Your Barcodes

Date: December, 2018 | CategoryProofreading Author: Ryan Szporer


 
 

It’s a bit of a conundrum in our technologically advanced day and age, but, without barcodes to scan, the retail world would effectively grind to a halt. The dependency is understandable though, as barcodes are just that much more effective relative to labels, they can contain that much more information. It makes sense then that companies would want to ensure the barcodes they place on their products are perfectly functional.

10 Ways to Improve Your Barcodes

1. Choose the Right Type of Barcode

There are many different symbologies (types) spread across one-dimensional (1D) and two-dimensional (2D) barcode categories. Logically speaking, not all of them will be good fits for your specific needs as a company looking to go to market. Just to illustrate that fact, 1D or linear types typically serve to code small amounts of text, while two-dimensional types can hold upwards of 4,000 text characters or 7,000 digits.

As a result, a list of the different types and their respective functionalities are worth considering here, along with how much space with which you have to work on the packaging. For example, EAN-8 barcodes, which contain a relatively minimalistic eight digits, are used on packaging with limited space. Size also enters into the equation as barcodes get printed in larger sizes to improve their readability and compensate for certain surfaces’ poor quality.

2. Make Your Barcodes the Right Size

There’s generally a balance between printing accuracy, where larger is better, and ease of scanning, where too large can pose a problem. On the other hand, barcodes can get as small as one 1/8 in2, but special printer considerations would have to be taken in such an instance so each element remains readable.

Furthermore, reducing the height of a barcode (or truncating it) may seem smart, but it reduces its ability to be scanned omnidirectionally. So, more difficulty at the point of sale and fewer sales overall. The X-dimension, or the width of the narrowest bar in a 1D code, determines the ideal size of the symbol as, with each target x-dimension, there is a target height. In two-dimensional symbols, the X-dimension meanwhile corresponds to the height and width of one cell, meaning all cells should be the same size.

3. Create Barcodes on a Separate, Individual Layer

When creating barcodes for your packaging, it’s critical that you do so on a separate layer (one that includes all barcodes). If barcodes are created on the same layer as other elements, you run the risk of obstructing them. The end result would be increased difficulty detecting them, leading to other potential complications at the point of sale.

4. Keep the Barcode Text Legible

You don’t have to just worry about the branding information on your product packaging. The text below the barcode, or Human Readable Interpretation (HRI) of the encoded value, has to be made legible as well. That means in a clear font that’s proportional in size to the code. The reason why, when barcodes are typically scanned in, is simple: The HRI is the back-up. It can be typed in as a last resort in case the code is unreadable.

5. Choose the Right Color Combination

It’s downright logical but rarely considered before it gets to the point when you have to create and print the darn thing. That’s because when one thinks of barcodes, they tend to see the iconic black bars on white background. However, not all barcodes are printed on white labels. Some are printed directly on the packaging, which isn’t always white either. So, the color of the bars must compensate for the required high contrast, with the bars having to be the darker of the two elements. Otherwise, it may not get detected.

6. Use the Right Substrate (Material)

The readability issue surrounding the need for high contrast extends to the packaging material. As the code can be printed directly on (or marked into) the packaging material, the latter effectively serves as the background. As a result, the nature of the material is a big concern and not just relative to the color. Texture and reflectivity can have an impact as well.

Glossy materials combined with adverse lighting conditions can cause reflections and, subsequently, no-reads, while backgrounds with busy and inconsistent patterns, like metallic surfaces, run into similar problems. Proper lighting can compensate for issues such as these, but there’s little substitute for packaging material that’s uniform to begin with.

7. Quiet Zones Are Your Friend

Quiet zones, i.e., the white space around the symbols, are unheralded as a barcode element. After all, they’re technically not part of the barcode. They nevertheless have a positive impact when it comes to barcode readability. In fact, barcodes with inadequately sized quiet zones can fail to scan altogether, highlighting their importance.

The rule of thumb is for quiet zones to be at least 10 times the size of a one-dimensional barcode’s narrowest bar. For two-dimensional barcodes, the minimum border is said to be the size of one cell on each side of the symbol.

8. Placement, Placement, Placement

It’s not just about making the barcode easy to find when it’s placed on the packaging. It’s about making it as easy as possible for it to be detected.

Placing a barcode close to the cut and fold lines doesn’t just make it look cramped. It may cramp the barcode’s style to boot. Barcodes should ideally be placed 8 mm or more from either, so they don’t get inadvertently obscured or even damaged.

9. Properly Integrate an Entire Barcode System

If you’re going to go into the trouble of taking advantage of barcodes as most businesses do in this day and age, it makes sense to leverage them to their fullest capability. It’s relatively easy to generate one online or purchase them outright from a member of the global standards organization in charge of barcodes, GS1. It can be easy too (but admittedly overwhelming) to integrate an entire system, including all the necessary pieces of software.

Even if you’re sending jobs to a print house, there’s a good chance you will need to create them yourself, using barcode label design software. Additional software that can come in handy? Barcode inspection software to ensure its readability in both digital and hard-copy formats and inventory software, with which you can scan barcodes to bring up individual product records (instead of just the number), track units, and manage orders.

10. Embrace the Future with RFID

Because of how ingrained in our culture barcodes have become, it’s easy to forget how much of a technological paradigm shift they represented when they were first introduced in 1974. And because barcodes were effectively designed to blend into the background, generally unnoticed as the visual equivalent of white noise so as not to distract from the packaging itself, it has become easy to take them for granted from a marketing standpoint.

That doesn’t mean they have actually been forgotten, though. In fact, even though you may not notice them, barcodes are gaining significant ground technologically speaking. For example, Digimarc barcodes are embedded in the packaging itself, which can be scanned just as if it were a traditional barcode.

Barcodes aren’t just for containing information reserved for the company anymore. By leveraging RFID (Radio-Frequency Identification) technology, companies allow customers to scan codes and access information directly aimed at them on their phones, including, but not limited to, marketing campaign videos or loyalty program offers.

Businesses still have the option to track inventory using RFID tags, making it arguably the next evolutionary step as far as barcodes are concerned. And it’s already here. Much like the barcode itself, it’s not a matter of if but when the phenomenon becomes widespread.

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Check out how GlobalVision can help with barcode inspection & quality control.

Managing Barcodes in Packaging Quality Control

Ensuring Barcode Accuracy from Packaging to the Patient

File comparison using GlobalVision softwares

Date: November, 2018 | CategoryCompany Author: Ryan Szporer


The just-released GlobalVision Desktop 5.3 and GlobalVision Web 3.3 each bring exciting, new features to the forefront. The end result, for both deployment options, is greater overall ease of use, though.

Top new GlobalVision Desktop features include:

  • Text Inspection tweaks to insertions/ deletions, which are now easier to locate, along with the new ability to search for text when creating zones and resynching differences.
  • New user-friendly keyboard shortcuts are listed in a readily accessible in-app guide.

Top new GlobalVision Web features include:

  • A face-lifted Graphics Inspection Mode, complete with adjustable Flash, Master, and Sample panels.
  • Mozilla Firefox support.

Improved Insertion and Deletion Detection

GlobalVision Desktop users can now make use of a new search function. As the text is being selected to create a “zone,” possible matches in the opposite panel now pop up. Much the same mechanic lets users match text when resynching differences after the inspection has been run.

Also following inspections: Detected insertions and deletions get highlighted in red in only the corresponding panel, letting users easily determine the difference’s exact location.

GlobalVision Text Inspection Comparing two documents

The Wait for the (Bigger) Flash Is Over

GlobalVision Web users running graphics inspections can now make the Flash panel as big as they want. The panel, which flashes between the Master and Sample in rapid succession to highlight differences, can be resized or popped out as a separate browser window. Meanwhile, the Master and Sample panels can be toggled off altogether, allowing for a fully customizable inspection view.

GlobalVision software generating graphics report

More of Color Inspection Mode

Color Inspection Mode, which innovatively confirms the accuracy of Pantone, LAB, CMYK, and RGB values at select points, has also been updated. A streamlined, new look to the user interface now accompanies an additional inspection “action.” Point to Point inspections can now be run, where, instead of having GlobalVision Desktop automatically compare the same point on the Sample to the one on the Master, users specifically pick points on each file to compare to each other.

GlobalVision Color Inspection Tool

Other Updates:

  • Sleeker designs coupled with general user-interface improvements.
  • U.S. Postal Service 4-State barcode support in GlobalVision Desktop Barcode Inspection.
  • Available French, German, and Spanish translations of GlobalVision Desktop itself.
  • Simpler processes to regain access to locked-out accounts in both versions.

Before, locked-out GlobalVision Desktop and Web users had to contact administrators to log back in. Now, they can re-activate their accounts on their own through an email notification (Web) or by simply waiting until their system’s pre-determined lock-out period ends to try logging in again (Desktop). The forgotten-password retrieval system has also been revamped in GlobalVision Desktop, which emails a temporary password to users upon request. Hassle-free.

Ultimately, it’s one of many additional features designed to simplify the lives of GlobalVision users. For a complete list, read the release notes for GlobalVision Desktop 5.3 and GlobalVision Web 3.3.

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Why Error-Free Packaging, Labeling Is a Must

Date: November, 2018 | CategoryProofreading Author: Ryan Szporer


Pristine, error-free packaging, and labeling undeniably look good, but it’s more than that. It’s a necessity, regardless of the industry in question. Of course, it conveys brand strength, but, more importantly, it’s about respecting regulations that were put in place for a reason.

Mislabeling Misadventures

The strength of those regulations (and the severity of the penalties for breaking them) depends on the country. For example, in the United States, the Fair Packaging and Labeling Act with the Uniform Packaging and Labeling Regulation (UPLR; and National Institute of Standards and Technology Handbook 130) require consumer commodities to clearly disclose packaging’s contents and manufacturer info. The goal is for customers to be able to make informed purchasing decisions through the comparison of accurate price and quantity information on packaging.

Additional regulations meanwhile outlaw deceptive packaging and labeling. At both the federal and state levels, false advertising and labeling laws exist, with offenders risking additional liability to any victims. Victims can include consumers who are harmed by the product or businesses further down the supply chain who unwittingly purchased the product. If, on the other hand, a party down the supply chain discovers the fraud but fails to take action, they could be responsible too.

The aforementioned laws are admittedly not all-encompassing. State laws can differ and the FPLA sometimes delegates regulatory and enforcement responsibilities to the agencies who oversee individual industries instead. For example, the Food and Drug Administration regulates packaging and labeling in the food & beverage, cosmetics, medical devices, and pharmaceuticals sectors.

Food and Drug Labeling as a Case Study

Taking the food & beverage sector as an example, put simply, the packaging must contain what the label says it does. If the FDA has reason to believe packaging is inaccurate, that it falsely claims the product inside is 100% fruit juice, for example, imports can be detained without physical examination. The product effectively gets prevented from being distributed (and sold).

When a manufacturer is a guilty party, the FDA may issue a warning. In the event the manufacturer does not comply and correct the issue, the FDA takes additional legal action to ensure the product gets removed from the market, without it being permitted to return until the issue has been corrected. Criminal fines and even prosecution may result depending on the infraction.

Fines up to $500,000 for misdemeanors that result in death can be doled out. A misdemeanor, which would not require proven intent, can also result in up to one year in prison. A felony, which implies intent or a subsequent violation after the first, can lead to a maximum of three years instead.

In the case of the pharmaceutical industry, which is also under the purview of the FDA and whose customers depend on packaging for accurate dosage information, it’s easy to see why penalties need to be especially severe. A single misplaced period can have huge negative ramifications.

Performing Labeling and Packaging Inspections

A packaging or label error doesn’t have to be fraudulent to be costly. In fact, a great deal of mistakes are simply caused by human error. Market research indicates that 60% of product recalls are caused by workers. And it’s easy to see why. Typos can easily be created and then missed due to proofing fatigue during the artwork-creation and printing processes.

It only reinforces the need for failsafes, like a digital inspection platform, to improve upon the efficiency of a company’s quality control. Performing labeling and packaging inspections at each stage of the workflow reduces the risk of a recall and the number of required revision cycles, so products get to market faster, without any errors.

Inspections are going to be performed anyway, including potentially by the governing body in the question itself. It only makes sense that a company would want to put its best foot forward in preparation. Having previously integrated robust quality systems is one key to success in such an instance. Not having to correct an error after the fact is another key to success in general.

There is obviously a difference between fraudulent practices and innocent errors that simply do not get caught in time. Unfortunately, they can each have severe consequences. What separates them from one another is how, instead of actively trying to skirt regulations, companies can actively try to prevent mistakes. It just takes a conscious effort to improve upon internal processes.

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Get your complete guide to meeting FDA labeling requirements here

Take the first step towards error-free packaging and labels by starting your free trial of GlobalVision

Learn how some of the world’s top pharma companies have cracked the efficiency code with automation

The Plain Packaging Dilemma of Legalized Cannabis in Canada
 

There’s still a lot of work to do before cannabis gets legalized in Canada on October 17.

Compliance with the Cannabis Act

One of the highest items on producers’ priority lists will undeniably be ensuring compliance with the “Cannabis Act.” That involves toeing the line regarding packaging regulations, which haven’t impressed either companies in the emerging industry, who find them too restrictive, or some big tobacco players, who find them too lax, relatively speaking.

For example, Canada’s largest tobacco company, Imperial Tobacco, has gone on record through head of corporate and regulatory affairs Eric Gagnon as pointing out cannabis companies can include a graphic like a logo on packaging, whose format they can choose and add color to. Those are things tobacco companies cannot do under their new regulations.

Health Canada has explained the discrepancy by arguing the two industries require different approaches, saying in an email to Global News: “While regulations for both substances are based on evidence and on the common objective of protecting Canadians—especially youth—they are different products with different risks…”

Nevertheless, it’s difficult to overlook the similarities between the two, as each product is required to be sold in overwhelmingly plain packaging, which, Gagnon conceded, “limits their [cannabis producers’] ability to sell themselves.”

While Gagnon could have theoretically been speaking of constraints to the tobacco industry, he had been referring specifically to details surrounding a given cannabis brand’s aroma being banned (among other elements). The thought process here is to deter interest in children. It’s an interesting dynamic the government has created, requiring itself to toe a line as well, this time one between making the overwhelmingly popular decision to progressively legalize cannabis and not being seen as too soft on the drug.

Cannabis Challenge with Contraband

Jamie Goren, the director of North American sales for IMS, agrees some of the packaging requirements for cannabis are stifling, arguably unnecessarily so. Goren, who has over 25 years of professional experience in the printing and packaging space, sees the pharma template for packaging in Canada as being the better fit.

“When the government was making regulations and trying to establish a template for where to go in terms of packaging regulation, it was easy for them to retrofit existing tobacco rules or borrow from existing tobacco rules,” he said.

“They could have gone with a pharma template, where medical marijuana followed prescription drug rules and maybe recreational would have followed over-the-counter drug rules down the road. Instead they borrowed from tobacco, which is a little strange, because tobacco is an industry they’ve arguably been trying to kill for the last 20 years.”

Adding to the difficulty is the threat of black-market substitutes encroaching on sales. Keeping guidelines restrictive would lead to an unfair advantage for legal cannabis’ illegitimate counterparts. After all, flashier packaging can create the illusion of a superior product. Meanwhile, the plain packaging would be all too easy to counterfeit.

“Like any other consumer good, if you remove the branding element and a way for consumers to differentiate between a legal and an illegal product, it’s very easy to copy a legal product,” said Gagnon on the subject of tobacco in a piece appearing in The London Free Press.

It’s a conundrum that further complicates Canada’s position on the matter. The Canadian government can be seen as trying to accomplish a variety of goals by legalizing cannabis, including to protect consumers through the establishment of a high-quality, above-board supply of the product, i.e., the elimination of the black market. The plain packaging it’s enforcing as a requirement could end up being a boon to it instead.

Accuracy as a Substitute for Branding

As a result, compliance with the approval process may very well ironically end up a key differentiating factor for producers. It may become less about branding and more about accuracy in such an instance.

“I think it’s a matter of being accurate the quickest. I think the two go hand in hand. It goes back to the issue of being in a regulated industry and making sure you’re following all the guidelines,” said Goren.

Suggesting digital proofreading software as the best way to save time approving packaging and getting to market with compliant packaging, Goren said it boils down to increasing efficiency. As daunting of a task entering the cannabis industry seems, lessening the workload for producers is possible and potentially a key to success.

“If it has to be approved by an outside body like Health Canada, you want to ensure the least amount of revisions and the least chance that something goes wrong and that you require a recall once it’s already out there,” he said.

“You could set up higher-speed production lines or engineer efficiencies into the manufacturing process that might drive 5-10% more efficiency on an hour-to-hour basis, but if you can get packaging through the approval process and onto the production line three days earlier, you’re going to be 200% ahead of the game in the long run.”

And whoever gets to market quickest effectively has the best chance at winning that game.

Find out more on the legalization of cannabis in Canada in the following episode of our web series, Unpacked. For additional information on how GlobalVision can help you improve the efficiency of your packaging workflow, visit our website or contact us.

 

Going Beyond Sustainable Packaging to Reduce Your Carbon Footprint

Date: October, 2018 | CategoryProofreading Author: Ryan Szporer


Every minute, 1 million plastic bottles are being bought all over the planet. It’s fair to say each one won’t end up being recycled either. In fact, 91% won’t be, leading to a lot of unneeded plastic clogging up the eco-system.

To help combat the situation, a few years ago the Coca-Cola Company came out with a fully recyclable bottle made from plants, which impressively fits into a closed-loop system. In a closed loop, materials are fed back into the system through composting or recycling. However, they can also be reused or repurposed. For example, Samsonite takes those plastic bottles and uses them to create luggage.

 

 

What Is True Sustainable Packaging?

True sustainability doesn’t just take into account materials that go into packaging, though. True sustainability also considers potential waste during the production process. That’s one misconception surrounding sustainability. When introducing end-to-end sustainability, you actually need to look back to the very beginning, to the point where the packaging is designed and then approved.

For example, the packaging-approval process can result in many rounds of revisions until everything is ready to produce. The result can create wasted resources if your process isn’t as tight as possible, even if the packaging itself is 100% sustainable.

Significant resources get wasted when mistakes slip through your supply-chain cracks, into stores, and potentially into customers’ hands. Avoidable errors can result in recalls leading to heaps of wasted packaging that have no value. In 2015 alone, 77.9 million tons of municipal solid waste generated in the United States consisted of containers and packaging. Over one-third of that total ended up in landfills.

Reducing Your Carbon Footprint

Ultimately, it’s about reducing your carbon footprint as a whole. That includes securing your product packaging workflow through effective quality control. Preventing recalls by catching errors means less packaging and less waste and a lot less gasoline consumed. After all, the resources you need to carry out recalls, which cost on average $10 million in the food industry, don’t include the transportation and labor costs of putting more packaging through your supply chain and re-shipping the product. It all hurts your bottom line and the packaging footprint you’re trying to market as sustainable.

So, it’s time to start looking beyond your product at your complete end-to-end process. Many companies are integrating new technologies and automated systems that can spot errors before going to print as a pre-emptive strike against recalls. The point is, to address sustainability, it’s important to consider how products are made and how to be as efficient as possible with the resources available.

It turns out the idea that integrating sustainable packaging leads to higher costs is actually a myth. Studies show that companies that look to become more eco-friendly overall enjoy as much as an 18% return on investment increase. That’s potentially a lot of green for going green.

Outside-the-Bottle Thinking

Getting there requires a lot of outside-the-box thinking. Ideally, the packaging itself would fit into a closed loop. Multi-functional designs are also popular. Think edible food packaging as a way to combat the plastic bottle problem instead. In fact, edible water pouches made from seaweed are being developed as we speak. That’s not just outside-the-box thinking. That’s outside-the-bottle thinking.

How can you take advantage of the eco-friendly wave of edible packaged water forming behind you? It can actually be quite simple, literally. Simple packaging designs made from single materials are more easily recyclable. As long as you do your research and strike the perfect balance between functionality and sustainability, you’ll find yourself on the right path.

The trick is leaving as light of a footprint as possible as you do, which also involves making sure your sustainability efforts aren’t erased by production missteps.

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Girl working in her office
 

Date: August 28, 2018 | Category: Proofreading | Author: Ryan Stevens


Digitization is inevitable, as we all know. Nonetheless, printed manuals offer specific advantages over digital texts that businesses use for their staff training. Virtually all specialized surveys find that print-documentation properties such as portability, readability (legibility), and quickness, with which one can absorb large portions of information, make print manuals a preferred choice for most readers.

Reading a print manual also increases engagement, which in turn results in a better outcome from training. We can compare a training manual to an ad that aims at attracting and retaining your target audience’s attention. In this case, the audience consists of your employees, who are supposed to stay focused during training sessions and gain as much long-lasting knowledge as possible.

How the Brain Processes Print and Digital Formats

Take a look at the table below that is from a survey conducted by Temple University for the U.S. Post Office and compares the performance of print and digital materials. The researchers have studied the effects of ads on the audience, but the very same principles and outcomes apply to print and digital documents in general.

How Paper Content Affects Our Brains

If you want your employees to process the information you present to them more quickly, then digital documents are a better choice, the survey finds. But you want much more from corporate or professional training. Looking at the survey results, we see that print documents, including print manuals, engage viewers for more time. Furthermore, respondents are reporting they recall many more details about the subject they have learned through print media a week after they saw the information. Bearing in mind that respondents have about the same preference for print and digital media and have absorbed about the same amount of information, then you definitely should opt for the format that creates longer-lasting memories about the subject you train. And this format happens to be print manuals.

For many reasons, our brains process print documentation better than digital formats and produce longer-lasting memories when print manuals are involved. Sure, digital still has advantages when interactive info or animated screens are involved, but we all tend to remember more information and for a longer time after we view it in print media.

Attributes of Print Manuals and Digital Counterparts

Let’s now look at some major attributes of printed and online documentation and then try to determine which properties of each provide benefits when better employee training is required.

A major advantage of print manuals is their portability. Despite the widespread digitization and internet availability, you still have plenty of scenarios where online or digital documents are inaccessible or too slow to be useful. Digital is fine when you run a training session in a New York-based headquarters, but it is barely useful if you are educating your employees in the field or in remote areas.

Then you have readers’ preferences concerning reading a hard copy versus electronic documents. A survey by the Wall Street Journal reveals the majority of U.S. internet users simply prefer print books compared to e-books and other electronic documents.

Percentage of People Who Prefer Print over E-books

As you can see, a total of 79 percent of U.S. online users are reading more or the same number of print books as compared to e-books. A good number of users will still print out and then read an online or digital document if they have a choice.

This is specifically true for extended documentation that contains more than a few paragraphs or, say, 800 to 1,000 words. One may argue that younger users are more comfortable with digital documents and online manuals, but one should still explain why all people create longer-lasting memories when using print manuals. It is not the time to dig deeper into advanced aspects of neuroscience, but we have a lot of research and survey data that confirms printed manuals produce better results when you need your employees to focus on the subject of your training and also remember numerous specific details.

Scientific research also finds that reading paper is about 30 percent faster compared to reading off the screen. This means print manuals are clearer, compared to their digital counterparts, especially when reading on a small display such as the screens of mobile devices.

Manuals are for continuous use and they are not one-time training materials. Most of your employees will need to refer to these manuals from time to time and there are many scenarios where reading the info on a screen is not advisable.

We are not even speaking about emergencies here. Obviously, you will not have your online manual available in case of a power outage, for instance, but you can have your printed manual on hand at any time, once you have completed the training course in question. Yes, you can lose or damage your print manual, but it is definitely more “available” compared to digital documents that depend on power sources, networks, and/ or connections to other devices.

Final Thoughts

You should not take for granted that printed manuals produce better results when training employees. For instance, if you need to update a manual on a weekly basis, a digital format may be the better choice.

Thankfully, automated inspection options exist, so as to prevent the need to continually have to correct errors, on a wide variety of formats, including both digital and hard-copy documents before they get published/ printed. Errors run the gamut from common misspellings to text discrepancies between revisions that are easily detected by specialized software. Regardless of the format, accessibility in addition to content is king. In many ways, print manuals are just more accessible than digital ones.

Print manuals help your employees remember required information for more time and also keep their attention on the subject you are teaching. As most corporate and professional training courses involve a large volume of information and very specific details, it would be a good choice to opt for print manuals to produce better outcomes.

About the Author

Ryan Stevens is a print expert who enjoys sharing industry knowledge with print enthusiasts all over the web. As CEO of Replica Printing Inc., Ryan is involved with all major printing styles and options on a daily basis.

Cartoon of the quality management system for ISO regulation

Date: August, 2018 | CategoryQuality Author: Marvin Magasura


 
 
 
 

What is a Quality Management System? 

A quality management system (QMS) is a term that refers to a system in charge of documenting all processes, responsibilities, and procedures for achieving quality objectives and policies. A QMS allows companies to direct and coordinate their operations to meet both regulatory and customer requirements while also improving their efficiency and effectiveness on a regular basis.

ISO 9001:2015 is the international standard that specifies all the requirements needed to implement a quality management system. In fact, most people use the term QMS as a synonym for the ISO 9001 family even though the latter is only a document that describes the former.

The Importance of a Quality Management System

Why is it so important to implement a quality management system into your quality processes? Quality management systems actually serve plenty of purposes, including:

  • Engaging staff
  • Lowering costs
  • Reducing wasted materials
  • Setting company-wide direction
  • Identifying and facilitating training opportunities
  • Improving processes

Benefits of Quality Management Systems

What are the advantages of using a Quality Management System?

Once implemented, quality management systems have the power to affect all aspects of your company’s performance. However, the design and implementation of a QMS will bring you two overarching benefits:

  1. Meeting the organization’s requirements ensures that your company complies with industry regulations and provisions of services and products in the most cost-effective way. In the end, this will create room for growth, expansion, and profit.
  2. Meeting customers’ needs will help to build trust in your company, in turn engaging even more customers, sales, and profits.

Other advantages include preventing errors, reducing costs, helping to communicate a willingness to produce consistent results, improving your company’s offerings, and ensuring all processes are completely controlled and defined.

 

 

Quality Management Standards

As we previously mentioned, the ISO 9001:2015 standard describes all the requirements that a company must meet to implement its own quality management system. By far ISO 9001:2015 is the most implemented and recognized QMS standard on the planet that counts for complete international acceptance.

However, there are plenty of other QMS standards available, such as the ISO 14000 family that deals with environmental management systems, the rest of the ISO 9000 family (including both ISO 9004 and ISO 9000), ISO/TS 16949 for QMS intended for automotive-related products, ISO 13485 for medical devices, and ISO 19011 for auditing management systems.

Requirements to Implement a Quality Management System

All quality management systems must address a company’s unique set of needs; however, we can name a few general elements that all QMS have in common, such as:

  • The creation of a quality manual.
  • The existence of quality objectives and policies.
  • A set of procedures, records, and instructions about all internal processes, data management, quality analysis, improvement opportunities, and customer satisfaction.

Each aspect of a QMS is intended to serve a specific purpose that in the end will help to achieve the final goal: meeting both the organization’s and customer’s needs.

How to Implement a Quality Management System

Before establishing a QMS, you must consider several elements. To begin, make sure that your decision to implement a quality management system is a strategic choice only influenced by your needs, objectives, services, and products provided. Now that you’re clear about what to do, here are the basic steps to implement a QMS:

  • Design and Build: They deal with the structure of the QMS, along with the plan for implementation and all its processes.
  • Deploy: In this stage, you’ll need to break each process into multiple sub-processes. It also includes staff education and documentation, training tools, and metrics.
  • Control and Measure: These stages are accomplished by systematic, routine audits of your QMS.
  • Review and Improve: In this stage, you’ll deal with the results of the audits. The goal is to determine the efficiency and effectiveness of all your processes regarding your objectives.

Conclusion

A product’s quality can be measured in terms of durability, reliability, and performance. Quality is a crucial element that differentiates your company from its competitors. By implementing proper quality management systems, you are ensuring that all necessary changes in your processes are implemented, which eventually leads to superior quality products and, in the end, bigger profits.

Are you ready to streamline your workflows by implementing a quality management system? Learn more by requesting a demo of GlobalVision here or try our web-based proofreading software, Verify, for free!


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