Three doctors holding globalvision checklist for SaaS solutions
 

Known for keeping their cards close to their vests to prevent other players from sneaking a peek, drug companies waited until the last possible moment to move to the cloud. Now sufficiently satisfied that their security concerns have been addressed, they’re finally poised to reap the benefits.

Positive Side-Effects

The advantages the cloud offers are wide-ranging. They run the gamut from facilitated corporate communication between teams in different parts of the world to lower operational costs, both of which are to be expected to a certain extent. They are arguably even interconnected as increased collaboration can help lead to streamlined operations.

However, other benefits aren’t as obvious. These include the flexibility of a scalable IT infrastructure (we’ll get to that later on), and, yes, even increased security. That would be through a variety of measures like encryption, cloud data protection gateways, and hybrid setups, which allow companies to store confidential data on private clouds.

Security concerns within the industry were in part due to required compliance with laws and regulations such as those enacted by the Health Insurance Portability Act. They’re also in part due to best practices, which logically state that sensitive, proprietary information should be protected much like cubs would be by a grizzly bear.

However, as has long been established, if done right, cybersecurity should present no more of an issue than implementing proper physical security measures would in the real world. There is a natural apprehension to deviate from what has been the norm for decades, but the reality is the cloud can be more secure than a brick-and-mortar fortress of a casino, and, it should be noted, Ocean’s Eleven-esque heists happen only in the movies.

Digital meetings can help to reduce paper waste

Untapped Potential

Even though early forms of cloud computing can be traced back as far as the 1960s, the concept really only started to gain mainstream traction this century, with the launch of Amazon’s Simple Storage Service (S3) in 2006.

From that point on, things ramped up quickly. it didn’t take long for IT giants like Google, Microsoft, and Cisco to get in on the action with offerings of their own by 2008. In 2014, an IDG Enterprise study meant to estimate the extent to which the cloud has permeated into corporate consciousness reported that 69% of respondents “have at least one application or a portion of their computing infrastructure in the cloud.”

To illustrate how long it’s taken for big pharma to catch on, one of the earliest adopters within the industry, Pfizer, had been developing an online clinical trial system back in 2013, but ultimately abandoned the project. The silver lining of that cloud, though? The experience exposed Pfizer to the medium’s massive untapped potential and the firm has since revisited it.

The industry-wide shift is now well underway, signaled by the full-court press mounted by software vendors who have been developing cloud-based solutions for specific use within pharma. It’s hard to dispute the advantages firms would be foregoing by holding out any longer.

SaaS: Software as a Solution

GlobalVision cloud integrating all kinds of inspection work on MAC and PC

For instance, regarding that scalable IT infrastructure, the cloud helps make pay-as-you-go Software-as-a-Service (SaaS) applications both affordable and accessible anywhere… on virtually any device. These include web-enabled or web-based options, with the former being beneficial to firms seeking to provide remote access to legacy applications. Applications that make up the latter are characterized by lower deployment costs and access directly via the web, with one potential drawback being the pre-requisite enterprise-wide standardization of browsers.

Software solutions exist for everything any pharmaceutical company could want or need, providing means to mine massive amounts of data for the purposes of drug research, for one example. For another, automated quality control platforms like GlobalVision positively impact ROI by minimizing the amount of unnecessary recalls due to packaging errors.

Featuring a (Mac or PC) desktop deployment option as well, GlobalVision is the first solution of its kind to take to the cloud, effectively embracing what has become an undeniable trend in computing in general, and, now, pharma by all accounts.

It’s admittedly only recently that pharma has come to take its seat at the table and it may be somewhat of a gamble, but that would be the case no matter the game. It just so happens that, in this one, most everyone wins.


GlobalVision is the leading developer of proofreading technologies for pharmaceutical packaging. Learn how GlobalVision has helped top Pharmaceutical Companies in quality control.

Request a free trial for GlobalVision Digital Inspection Solution


How More about How Error-Detection Software Ensures Data Integrity

 

Laptop, hard drive, monitor and other devices

Date: December, 2016 | CategoryQuality Author: Mike Malz


What Does Data Integrity Mean?

Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stays unchanged relative to that complete state.

It is important to understand what data integrity really means in order to be compliant.

Maintaining or keeping data consistent throughout its lifecycle is a matter of protecting it (security) so that it’s reliable. And data that’s reliable is simply able to meet certain standards, with which compliance is necessary. For example, the FDA uses the acronym ALCOA to define data integrity standards and to relate to good manufacturing practices.

Data Integrity Best Practices:

Data is expected to be:

  • Attributable – Data should clearly demonstrate who observed and recorded it when it was observed and recorded, and who it is about.
  • Legible – Data should be easy to understand and recorded permanently and original entries should be preserved.
  • Contemporaneous – Data should be recorded as it was observed, and at the time it was executed.
  • Original – Source data should be accessible and preserved in its original form.
  • Accurate – Data should be free from errors, and conform with the protocol.

The Importance of Data Integrity

Why is data integrity important?

Data integrity has become a serious issue over the past few years and therefore is a core focus of many enterprises. The FDA published a Data Integrity Guidance Document outlining compliance with CGMP that addresses the role of data integrity for the industry.

The document is a result of the FDA increasingly observing violations involving data integrity during inspections. These violations have led to FDA warning letters, import alerts, and consent decrees. The guidance document answers integrity questions and strives to clarify what the FDA expects from businesses.

A clip board including a checklist of items

How can Data Integrity Risks be Minimized?

In today’s marketplace, companies need to feel confident that there is no loss of quality when using computer systems. To accomplish this, there are effective strategies that companies may implement to manage their data integrity risks and ensure their data respects the ALCOA principle. By moving from a reactive to a proactive way of thinking, the following key requirements and controls may be put in place to ensure data integrity and minimize risk for your organization.

12 Ways to Reduce Data Integrity Risk:

1. Ensure all computer systems are 21 CFR Part 11 compliant

21 CFR Part 11 is an FDA regulation that applies to electronic records. It is required to ensure that electronic records are trustworthy, reliable, and equivalent to paper records. All computer systems that store data used to make quality decisions must be compliant, making it a perfect place to start with data integrity.

2. Follow a software development lifecycle

A Software Development Lifecycle methodology helps oversee that quality-related tasks are performed to address pertinent lifecycle phases from software development, software testing, integration, and installation to ongoing system maintenance. All computer systems should be appropriately developed, qualified, tested, and assessed on a regular basis.

3. Validate your computer systems

Software validation provides documented evidence to deliver assurance that a specific process consistently produces a product that meets its pre-determined specifications and quality attributes. To ensure your system can be validated, it is key to work with vendors that provide validation.

4. Implement audit trails

A secure, computer-generated, time-stamped audit trail records the identity, date, and time of data entries, changes, and deletions. Audit trails ensure the trustworthiness of the electronic record, demonstrate necessary data ownership, and assure records have not been modified or deleted.

5. Implement error detection software

Automated inspection software can help verify important documents to ensure their accuracy. Manual proofreading or inspections are proven to be inefficient and often cannot assure that files are error-free.

6. Secure your records with limited system access

All systems should require a login with at least two unique pieces of information and provide access only to required individuals to guarantee data integrity.

7. Maintain backup and recovery procedures

A backup and recovery strategy is necessary in the unexpected event of data loss and application errors. This procedure ensures the reconstruction of data is achieved through media recovery and the restoration of both physical and logical data and creates a safeguard to protect the integrity of your database files.

8. Design a Quality Management System with SOPs and logical controls

Quality Management System with Standard Operating Procedures builds quality into the process by systematically controlling the process. It is essential to write and follow good effective procedures to ensure clear accountability.

9. Protect the physical and logical security of systems

Controls are needed to protect the physical and logical security of your systems, change management, service management, and system continuity. This will assure continuous development for your organization and support of systems.

10. Establish a vendor management qualification program

It is important to evaluate all vendors supplying products to certify that the products are quality products that meet needs (such as validation services). A continuous appraisal is required following the initial evaluation. Often asking what data integrity procedures your vendors have in place will help with your own organization’s data integrity practices.

11. Properly train users and maintain training records

Users should be properly trained so that they have the right education and expertise to perform their job competently. Documented training records provide this proof.

12. Conduct Internal Audits to evaluate controls and procedures

Internal audits ensure that all procedures are followed and that continuous improvement is emphasized.

Data Integrity Success

If you are reading this article, you are most probably aware of how important it is to ensure your data is not compromised. The impact of dangerous data can have resounding consequences on any organization no matter the size. However, if data integrity is thought of as a process, the data infrastructure can become an asset instead of a liability.


GlobalVision is the leading developer of automated quality control technologies for
every stage of the pharmaceutical workflow. Learn how GlobalVision has helped top Pharmaceutical Companies in quality control.

Request a free trial for GlobalVision Automated Proofreading Solution


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What is QMS? Quality Management System?

Software Development & Data Integrity

Misconception about printer's proof

Date: October, 2016 | CategoryProofreading Author: Reuben Malz


A brand company goes through many revision cycles until a final PDF is approved.

A typical cycle may look something like this; management gives the go-ahead to print 500,000 labels. Then, purchasing fires off a purchase order to the printer with the approved PDF file attached.

Most people consider this to be the end of the line and the expectation is that the printed labels will be delivered in a few days.

However, the packaging engineers know better. The Brand companies approved PDF is far from being “Print-Ready”.

How to Know When a Printer’s Proof is Print-Ready?

The Printer depends on professionals for many steps of the printing process. From pre-press to trap, bleeds, imposing the file, and correcting errors in the Brand company files, and much more. The end result is a derivative of the Brand company’s approved PDF file. This is the “Printer’s Proof”.

But Printing still cannot begin.

Remember the Purchase Order the Brand company sent to the Printer? This is the “Contract”.

In order for the printer to get paid for printing 500,000 labels, the contract requires that the 500,000 labels match the Brand company’s approved PDF file exactly, NOT the Proof!

Printing cannot begin until the PDF is verified against the Proof, but, whose responsibility is it to check the Proof?

The Importance of Verifying Print Proofs 

Most printers will send the proof to the Brand company and wait for the signoff before starting print production.

But even with the Brand companies signoff of the proof, the printer cannot take the risk and assume there are no errors in the Proof for the following reasons:

  • The Brand company may sign and never have checked the Proof.

  • The Brand company may have checked quickly and missed an obvious error.

  • The responsibility is usually assumed to be shared.

  • The Purchase order has legal weight.

  • The Brand company may be in the wrong and refuse to pay.

  • The Brand company may be wrong, but the Printer will not want to lose the customer.

  • The Brand company may be in the right but loses time to market.

  • The Brand company may be in the right, but delays production.

It is for these reasons that both parties will need to verify the Printer’s Proof.

 


Additional Resources 

GlobalVision is the leading developer of proofreading technologies for retail and consumer packaged goods. Learn how GlobalVision has helped Consumer Goods companies of all sizes in quality control.

For more information about GlobalVision and our market-leading Quality Control Platform for print and packaging, please visit our website or read more about the benefits of automated proofreading software on our blog. 

Ready to make the switch and automate your quality control processes? Request a free trial for GlobalVision Print Inspection Solution.

Learn More about How to Create Error-Free Packagingby watching out video below. 

 

Monitor screen filled with all kinds of inspection work

Date: April, 2016 | CategoryCompany Author: Reuben Malz


 
 

Ghent (Belgium), March 16, 2016 – Esko has wholly updated its software solutions and relaunched them under the umbrella brand name “Esko Software Platform”. It’s the next version of the well-known portfolio of integrated software solutions for design, prepress, workflow automation, color management, and supply chain collaboration for packaging, labels, displays, and signs.

The Esko Software Platform is enhanced with new capabilities and delivers a unique user experience. The full range of innovations and integrations of the Esko Software Platform will be demonstrated for the first time at the upcoming Drupa 2016, scheduled for May 31 through June 10 in Düsseldorf.


Highlights of the Drupa release of the Esko Software Platform include:

  • More software modules made available as Software as a Service (SaaS) and subscriptions
  • Improved 3D support, especially when viewing objects in WebCenter and on mobile devices
  • A new Content Management module for WebCenter
  • ArtPro+, a totally new platform-independent native PDF prepress editor
  • New tools and libraries for multi-part POP design in ArtiosCAD 16
  • Planogram interface for Store Visualizer 16
  • New set of automated quality assurance tools in Automation Engine
  • Esko hardware integration in the workflow (Automation Engine Device View)
  • Improved user experience across all applications

A Platform for Quality Control

GlobalVision quality control solution tools are embedded in Automation Engine 16. Features now available from the automated workflow include a spell checker and automatic checking of barcodes and Braille against an approved profile. The quality check runs as a background process and results in an annotated and viewable design file for Automation Engine, WebCenter and in ArtPro+. This enables fast, systematic revision of all detected errors.

“Esko has embedded technologies from our partner GlobalVision and from our subsidiary Enfocus to eliminate time-consuming manual checks,” Zwaenepoel states. “Automated quality checking tools allow our customers to process more jobs with the same people and with fewer errors”. This innovation offers peace of mind and addresses the lack of skilled operators many companies are facing.”

Learn More about Esko Software and GlobalVision 

For more information on what’s new within Esko, please visit the Esko Software Platform.

If you want to learn more about GlobalVision’s market-leading proofreading software, request a free trial today.

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Learn More about How to Ensures Data Integrity


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What does GlobalVision do?

GlobalVision’s mission is to build software that standardizes quality approvals for product packaging and critical content. Our goal is to eliminate errors and automate inspections so companies can release products with confidence. Helping Businesses Bring Confidence to Quality Control. Learn more about GlobalVision.

What is GlobalVision Quality Control?

Automate Quality Inspections for Fast and Consistent Results. Speed up the proofreading process while improving the accuracy of your work by running digital checks with GlobalVision’s automated quality control tools. Learn more about Automated Quality Control.