Big Pharma Pokes Its Head in the Cloud (Finally)

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

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What is Data Integrity?

Laptop, hard drive, monitor and other devices

What does Data integrity Mean?

Data Integrity Definition: 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 stay 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.

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

The importance of data integrity

Why 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 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.

Here are the 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

A 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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Integrating QC Tools into Print Workflow Automation Solutions

Monitor with inspection work needing automation

For print professionals, the complexities of labeling and packaging can present numerous challenges. Ask any member of a prepress department and they will tell you that artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

The changing landscape of packaging and labeling

Product innovation, promotions, globalization, regulatory requirements and consumer demands, are all key factors that contribute to the increasing rate of frequency of packaging and labeling changes. In fact, modifications to packaging and labeling account for up to 10% of a company’s product selling costs, with the average large brand company updating approximately 800 SKUs per year.

If this is not enough of a challenge, audience engagement adds a new level of complexity. An average supermarket carries anywhere between 10,000 and 75,000 individual products, and most consumers purchase between 30 to 40 items on a weekly basis. With this competitive landscape, brand owners are always struggling through packaging and labeling innovations to engage the consumer to buy. However, the more elaborate the product packaging, the greater the challenge for the packaging print service provider.

For the prepress department, packaging and labeling challenges are growing exponentially as artwork becomes more intricate and vibrant. These challenges are further compounded by the need to work faster and more efficiently while maintaining the highest levels of quality control.

Fortunately, packaging and artwork management challenges can be addressed with the addition of a Workflow Automation Solution with Quality Control Tools. This union helps minimize the risk of product recalls while standardizing business processes and maintaining brand consistency and quality.

Integrating Automated Quality Control tools into a Workflow Automation Solution

Recently, Esko and GlobalVision announced the integration of the GlobalVision Quality Control Platform within Automation Engine, Esko’s workflow server. The result is a robust all-in-one quality assurance solution enabling rapid and systematic review of all detected packaging and labeling errors throughout the workflow, from upstream design to print.

“Today’s label and packaging production are complex and ever-changing, making it extremely challenging for companies to balance tight deadlines and quality. The partnership and integration between Esko and GlobalVision combine two best of class technologies to deliver the industry’s first fully automated solution to ensure the accuracy of the text, spelling, graphics, barcodes and Braille from initial design to the final print.”
– Jonathan Hou, Director of Technology at GlobalVision

The following Quality Control Tickets
are now available within Automation Engine Suite 16

Icons of GlobalVision solution

With the integration of GlobalVision’s QC tools into Esko’s Workflow Automation Solutions, the potential to produce high-quality error-free output, with minimum rework, is now realized.

For more information, please visit globalvision.co or info@globalvision.co

Learn how GlobalVision has helped leading Print and Packaging companies in quality control.  

Learn More about How a Label Error Can Ruin a Great Package Design

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