Author: John Hartwig

John Hartwig has a BS in Electrical Engineering from St. Cloud State University and has 20+ years of process, equipment and packaging engineering experience. John’s career involves custom equipment design through engineering leadership position in the consumer products, beverage and pharmaceutical industries. With King Pharmaceuticals, John was the Technical Operation’s Team Leader for a new drug platform with responsibility for pilot scale facilities construction, tech transfers, scale-up to commercial capacities, and product launch readiness. John has led engineering teams in capital projects, automation, reliability, qualifications, network strategy development and product track and trace (serialization) programs.

Leading the Way

Leading the Way

RemTech is committed to the advancement of education in the pharmaceutical, technology, and engineering industries. As part of that commitment, one of our Principals, Bob Matje, has worked closely with the International Society for Pharmaceutical Engineering (ISPE) throughout the years. Recently, the ISPE has published a new book, APQ Guide: Management Responsibilities & Review (MRR). Bob is a co-author on this guidebook and we are proud of his contribution and dedication to furthering education.

The International Society for Pharmaceutical Engineering is a not-for-profit association that provides for its members in scientific, technical, and regulatory leadership throughout the pharmaceutical industry. With their commitment to education, the ISPE facilitates the exchange of ideas and practical experience. The ISPE is a leader in next-generation technologies and solutions. You can learn more about ISPE and its role in the pharmaceutical industry by visiting here.

In their new guidebook, APQ Guide: Management Responsibilities & Review (MRR), the ISPE outlines the responsibilities of leaders in the communication and demonstration of pharmaceutical system support. The guide also lays out the expectations and evaluation of management as highlighted in ICH Q10. A digital copy of the guidebook can be found here.

Bob Matje and the rest of the team at RemTech are ardent supporters of furthering education. We work with many different organizations and we have our finger on the pulse of the pharmaceutical industry. We know the needs and opportunities in this industry, so we use that knowledge to help shape education so that students and team members can keep pushing the bounds of technology and innovation. At RemTech, we are paving the way for the pharmaceutical industry of tomorrow.

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8th Annual UGA/FDA Medical Device Regulation Conference

8th Annual UGA/FDA Medical Device Regulation Conference

It’s that time again! The 8th Annual UGA/FDA Medical Device Regulation Conference will be held on September 21-23, 2021. The conference is co-sponsored by the United States Food and Drug Administration and the University of Georgia’s International Biomedical Regulatory Sciences. This conference will be hosted virtually by the University of Georgia’s College of Pharmacy and will focus on quality assurance and regulatory affairs dealing with the medical device industry in the United States.

There will be a broad range of topics discussed at the conference presented by highly experienced professionals from the FDA and medical device industry and consulting firms. Proposed topics for discussion include FDA updates for CDRH and ORA, Remote Regulatory Assessment, International updates, and many others. The educational and networking opportunities provided at this conference will lay the groundwork for the future of medical device regulatory sciences.

 

 

Bob Matje, Principal at RemTech, is a member of the UGA Pharmaceutical Sciences Advisory Board at the University of Georgia, Atlanta campus. As a member of this board, Bob works to review the current college curriculum to ensure it is in line with current technology and industry needs. Bob is passionate about education and the future of the medical and pharmaceutical industry. RemTech shares that passion. At RemTech, we are committed to furthering education through conferences and programs like the UGS/FDA Medical Device Regulation Conference. We hope that you will consider being a part of this with us.

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RemTech Consultant: Lois Horne

RemTech Consultant: Lois Horne

 

At RemTech, we know we are only as good as our team and we couldn’t be more proud of that team. The consultants and engineers that make up our team set us apart from the competition and build a quality foundation for everything we do. With quality in mind, we’d like to introduce you to Lois Horne, a consultant with an eye for quality.

 

Dr. Lois Horne has been a consultant with RemTech since 2016 and has proven herself as a vital member of our team. Lois consults in a variety of areas including Quality Assurance/Control, Technical Operations support, Validation, and project management.

 

Dr. Horne attended Lycoming College where she earned her B.A. in Chemistry with a minor in Biology. After graduating from Lycoming, she went on to earn her Ph.D. in Organic Chemistry from Clemson University. Lois has years of experience working in the pharmaceutical industry with a focus on Quality Assurance and Control.

 

With her background in chemistry and the mind of an engineer, Lois is perfectly suited to work with both Operations and Quality support. She works with companies to ensure their production processes are in line with FDA regulations and provides remediation for those who have fallen below those standards. Lois also specializes in cleaning and method validation. In everything she does, Lois is focused on ensuring the companies she works with are compliant and safe.

 

While Lois’ background is primarily in the Quality Control arena, her experience doesn’t stop there. She specializes in different validation areas, including cleaning, method, software, and process. Lois is a project manager with experience in Root Cause Analysis and Program/SOP establishment. She has the experience and knowledge to serve her clients in the best fashion.

Lois brings a unique set of skills to the team at RemTech. She is able to use her background in chemistry to support other consultants as well as her clients. Her personality and work ethic are valuable assets to our team. One of the things she appreciates most about working with RemTech is the network of consultants and engineers that assist and support each other.  We are so thankful that Dr. Lois Horne is a part of our team. She is part of what makes the RemTech difference.

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The DSCSA: What You Need to Know

 

November 27, 2023, is coming and it will be here before we know it. What’s so important about this date? It’s the date that the Drug Supply Chain Security Act (DSCSA) will be completely phased in. As pharmaceutical companies work to reach full compliance, here’s a quick refresher on the DSCSA.

 

What is the DSCSA?

 

The Drug Supply Chain Security Act lays out the requirements that everyone involved in the pharmaceutical supply chain must follow. This includes all manufacturers, repackagers, distributors, dispensers, and trading partners. The purpose of the DSCSA is to provide an interoperable system that will be able to track and trace prescription drugs as they are manufactured and distributed across the United States.

 

What are the benefits?

 

The DSCSA provides the FDA with the resources to better protect consumers against counterfeit drugs by tracking those drugs through the various stages of production. By building a system to track prescription drugs, the FDA and manufacturers will be better equipped to detect and remove potentially hazardous drugs before they get to the consumer.

 

What do I need to do?

 

The first step is to be familiar with the law. After you are familiar with your responsibilities laid out in the DSCSA, work with your trading partners to ensure that they know their roles.

A great way to make sure you are compliant with all the new regulations is to partner with a company that specializes in compliance and validation. RemTech consultants are experts in DSCSA laws and know what it takes to make sure you are compliant. Our consultants work to make you compliant through project management, staff augmentation, validation.

 

Don’t let the DSCSA deadline sneak up on you. We would love to answer any questions you may have and set you on the right path. Contact us today.

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It’s All Coming Together

It’s All Coming Together

A well-functioning machine can have many moving parts. Each of those parts has to work in conjunction with the other parts to make a machine that fulfills its designed purpose. If one part of an engine isn’t working properly, it affects the whole vehicle. In the same manner, all of the different pieces of equipment in your facility need to work correctly and synchronistical to ensure that your manufacturing process is functioning properly. At RemTech, we specialize in many areas. One of those areas is validation and qualification with a focus on the unique aspects and needs of your business.

 

Validation

While working with an organization, we work hand in hand with Quality, Technical, and Validation teams to produce documentation on the equipment that the facility uses or has recently purchased.

 

Installation Qualification

The Installation Qualification documents record information pertaining to the equipment in use, such as serial numbers, model numbers, voltage, etc. to be sure what was installed is what was expected to be installed. This document verifies that the equipment has been installed correctly and meets the standards set forth by the manufacturer and installation guidelines.

Operational Qualification

The Operational Qualification documents verify and record that the equipment is in proper working order. Tests are completed to ensure that the equipment operates as expected and according to the manufacturer’s specifications.

Standard Operating Procedures

Standard Operating Procedures, or SOP, provide users with directions on proper usage for each piece of equipment. These documents are specifically written to reflect the needs and operations of your company.

Preventative Maintenance

Preventative Maintenance documents are written for each piece of equipment. The PMs plan out maintenance for the equipment based on the manufacturer’s guidelines. PMs also take into account the usage of the machine so that the maintenance fits with the schedule of your facility.

At RemTech, we are focused on making sure your company runs like a well-oiled machine. Through validation and documentation, we work with your company to provide all the necessary resources that you will need for success.

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Writing Your Success Story

Every story has a beginning. A place to start. The story of your business starts with you. Your dreams, your goals, your aspirations, all make up your story. How do you make sure that your story leads to success? By partnering with a company that knows success. RemTech brings over ninety years of combined experience to guarantee your success. Through strategic planning, project management, and operational implementation, we will help you write your story of success.

Strategic Planning

Our consultants with work with you to analyze the individual needs of your company or project. We will identify any potential issues and develop a strategy to resolve those issues. Our team will work with you to establish a budget and timeline for completion.

Project Management

As experienced project managers, we will handle your project in a professional and timely manner. We specialize in the management of construction, renovation, procuring and installing new equipment, and many other areas. RemTech consultants can work as your representative while dealing with contractors to make sure you are getting the best quality work done for the best price.

Operational Implementation

We will assist you in creating a plan and in making that plan a reality, but we don’t stop there. We work to make sure that the implementation of your new project or process smooth and successful. Through staff augmentation, our consultants become a part of your team. We will also build teams and provide training to ensure your project’s success.

RemTech has years of experience writing success stories. When you join us, you can be assured that we will work tirelessly to guarantee the success of your project or process.

So what kind of story are you writing? Write a story of success, write your story with RemTech.

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From Ideas to Implementation

You have an idea. You’ve laid the foundation, you’ve set goals, and you’re ready to start your project. The next step is moving your project from an idea to a reality. RemTech specializes in project management and implementation. We put our years of expertise and knowledge to work for you to ensure the success of your project. From space utilization to procuring equipment to staff augmentation, the professionals at RemTech have the experience to help you succeed.

 

Space Utilization

 

The layout of your facility or workspace can have a significant impact on your productivity and overall workflow. The efficient placement of equipment, workstations, and production lines can bolster productivity while cutting down on wasted space and downtime. RemTech consultants will work with you to design a layout that will benefit your individual facility and maximize your space.

 

Procuring Equipment

 

Buying and upgrading equipment can be a daunting task. Verifying that you are getting the correct equipment for your facility or project while balancing quality versus price can be a challenge. RemTech consultants are up to that challenge. We have an in-depth knowledge of production equipment and the experience to know what will work best for you. We work with companies to upgrade and install new equipment while ensuring they receive the best value possible.

 

Staff Augmentation

 

For some projects, having a consultant may not be enough. In those cases, RemTech can provide staff augmentation to help meet your needs. Our consultants can be placed in your facility as a full-time member of your team. Our consultants can work with you on a daily, in-person basis to oversee the project and meet any needs that arise. Having a RemTech consultant as a long term team member provides the experience that you need without the need for an outside hire.

 

At RemTech, we want to see your project succeed and thrive. Joining with RemTech gives you and your team smart solutions to manage your business and project. Let us help you turn your ideas into reality. Contact us today to start your next project.

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Upgrading Windows Operating System

Upgrading Windows Operating System

Ensuring Data Integrity through Optimal Security and Performance 

Executive Summary

As Microsoft releases new updates and editions of Windows Operating System (Windows OS), it is harder to verify a device or network is running the right software for its job. This guide explains which editions of Windows OS are appropriate for the pharmaceutical industry to use, in compliance with FDA regulations and guidelines. Ultimately, upgrading to the latest edition of Windows OS will provide users the greatest functionality, especially in areas like serialization where large amounts of data is stored. However, an OS still in its lifecycle, with the most recent updates installed, can provide necessary data security and protection. This technology is the foundation of good data integrity, from record creation to destruction. Following this guide will ensure a device has the proper Windows OS for required functionality, and that it is maintained throughout the future.

 

Introduction

Windows Operating System (Windows OS) is software that controls the basic functions of a computer. With several Windows OS editions and updates, it can be complicated to know if a device has the proper OS for optimal security and performance. This guide provides an explanation of the differences in Windows OS, as well as guidelines for the use and importance of the appropriate one. This approach follows existing regulations and good manufacturing practices and applies to the most recent changes in pharmaceutical data, including serialization. It will explain the process of upgrading a device to a new edition of Windows OS, or updating a device’s current edition of Windows OS, and how to stay informed when to do so.

 

Supported Windows OS

With several different Windows OS editions, and versions of each one, monitoring the proper OS for a device can be confusing. To demystify this complexity, it is best to have a clear understanding of the important distinction between supported Windows OS and unsupported Windows OS. Supported Windows OS is a product Microsoft actively sells and maintains. This maintenance mostly consists of releasing updates that fix bugs and offer performance improvements that were initially overlooked, but also includes customer support services. Each edition of Windows OS continues to be supported until the end of its lifecycle. Currently supported Windows OS include Windows 8.1 and several editions of Windows 10.

 

When an edition of Windows OS concludes its lifecycle, Microsoft classifies it as unsupported. Unsupported Windows OS places the security and performance of systems at risk as Microsoft no longer releases updates that patch vulnerabilities nor provides customer support for it. Though there are exceptions where Microsoft updates unsupported Windows OS, as was done recently for Windows 7, this is volitional and rare (Warren, 2020). Because the use of unsupported Windows OS has inherent risks, Microsoft notifies their customers of important information regarding where a product lies in its lifecycle. To best determine if a particular device’s OS is supported, as well as key dates in its lifecycle, view the Windows Lifecycle Factsheet.

 

The Microsoft Product Lifecycle

The Microsoft Lifecycle Policy outlines the phases of Windows OS as it matures until being replaced with a newer edition and becoming obsolete. Microsoft states: 

“Every Windows product has a lifecycle. The lifecycle begins when a product is released and ends when it’s no longer supported. Knowing key dates in this lifecycle helps you make informed decisions about when to update, upgrade, or make other changes to your software.” (Windows Lifecycle Fact Sheet, 2020)

 

While distinguishing these key dates is important, it is also necessary to understand what they signify. Microsoft has different lifecycle policies for Windows OS, and with them different phases.

 

Fixed Lifecycle Policy

The Fixed Lifecycle Policy applies to editions of Windows OS like Windows 7, Windows 8, and some versions of Windows 10. This policy ensures at least 10 years of Microsoft Support for its respective product. Over this period, Microsoft maintains editions of Windows OS through two phases: Mainstream Support and Extended Support. Mainstream Support has a duration of at least 5 years, during which Microsoft provides security updates and incident assistance. Following Mainstream Support, Extended Support has a duration of at least 5 years and provides customers with security updates and additional paid assistance. Key dates for these phases can be found in Table 1, below, or the Windows Lifecycle Factsheet. For more information, view Microsoft’s Fixed Lifecycle Policy.

 

Edition of Windows Operating SystemsMainstream Support End DateExtended Support End Date
Windows 10 Enterprise LTSCJanuary 9, 2024January 9, 2029
Windows 10 Enterprise 2016 LTSBOctober 12, 2021October 13, 2026
Windows 10 Enterprise 2015 LTSBOctober 13, 2020October 14, 2025
Windows 8.1January 9, 2018January 10, 2023
Windows 7, service pack 1January 13, 2015January 14, 2020

Table 1: Key Fixed Lifecycle Dates for Windows OS

Modern Lifecycle Policy

More recently, Microsoft introduced the Modern Lifecycle Policy to incorporate newer products and services. Under this policy, Windows OS is supported if the conditions below are satisfied: 

  • Customers are current, as per the servicing and system requirements of the OS
  • Customers are licensed to use the OS
  • Microsoft currently offers support for the OS

Should a Windows OS require customer action to maintain its current status, this policy ensures a minimum of 30 days’ notice prior to its degradation. Additionally, should a Windows OS become obsolete without a successor, this policy ensures a minimum of 12 months’ notice prior to being classified as unsupported. Key dates of the Modern Lifecycle Policy can be found in Table 2, below, or the Windows Lifecycle Factsheet. For more information, view Microsoft’s Modern Lifecycle Policy.

 

Edition of Windows Operating SystemsEnd of Service for Home, Pro, Pro Education, and Pro for Workstations EditionsEnd of Service for Enterprise and Education Editions
Windows 10, version 2004May 27, 2020December 14, 2021
Windows 10, version 1909 November 12, 2019May 11, 2021 
Windows 10, version 1903May 21, 2019December 8, 2020
Windows 10, version 1809November 13, 2018November 10, 2020
Windows 10, version 1803April 30, 2018November 12, 2019

Table 2: Key Modern Lifecycle Dates for Windows OS

Security

Though it may seem trivial, upgrading to a Windows OS that is routinely updated via Microsoft Support is essential to data security. Updates are periodically released and are only available to supported Windows OS. They provide performance improvements for greater functionality, but more importantly patch vulnerabilities in the OS software. Though infrequent, these vulnerabilities are inherent within Windows OS and can be exploited by malware to access a device or network. Microsoft continually monitors for these weaknesses and newly discovered flaws to protect against them. This is why using a supported and updated OS is essential for data protection.

 

A recent case that best illustrates the risk to organizations without a fully updated, supported edition of Windows OS is the May 2017 WannaCry ransomware attack. WannaCry exploited a vulnerability in several editions of Windows OS to block access to, if not delete, stored files, before spreading throughout networks. It reached 150 countries and infected 230,000 computers, promising to restore access to data in exchange for bitcoin. One affected system, that of the UK’s National Health Services (NHS), interrupted appointments, surgeries, and ambulance transport, inducing costs totaling over $100 million as a result (What is WannaCry Ransomware?, 2020). While the computers impacted were running Windows OS with Microsoft Support, only those that had not installed the latest updates – patches that were released two months prior to the attack – were infected. This malware is one of many that demonstrate the importance of ensuring devices run on fully updated and supported editions of Windows OS in order to protect sensitive data.

Figure 1: WannaCry Ransomware Window (Whittaker, Z., 2019)

Performance

A device running a fully updated, supported Windows OS allows users to receive features that maximize use. Routine updates provide performance improvements, and upgrades to newer editions of Windows OS allow for even greater functionality. In Windows 10, this functionality includes security features like Windows Defender Antivirus, a program that gives added protection from third-party software, and automatic updates, an element which eliminates manual steps required to keep a system secure. Additional performance benefits included in the latest Windows OS incorporate greater cross-platform support, better cloud integration tools, and advances in user interface. All of these allow users to interact with data safely and efficiently.

 

Regulations and Guidelines

Within pharmaceutics, requirements and guidelines for specific data protections require the security and performance an updated edition of Windows OS provides. The FDA states:

“CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models.” (Clark et al., 2019, p. 17)

The security and performance offered by this technology serves as a basis for this, as the proper version of Windows OS minimizes data integrity risks. The FDA further stipulates systems “that create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records.” (Title 21: Food and Drugs, 2020) This requisite too can only be ensured with a trusted OS.

 

Likewise, the MHRA states:

“Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are or the required quality” (Clark et al., 2019, p. 47)

“The effort and resource applied to assure the validity and integrity of the data should be commensurate with the risk and impact of a data integrity failure to the patient and environment” (Clark et al., 2019, p. 48)

Thus, devices running updated and supported Windows OS are fundamental to not only drug quality but ultimately public safety. These standards ensure stored data is protected from modification or loss, and, when used in conjunction with proper practices, creates the trust and validation required between government, industry, and patients.

 

Good Manufacturing Practice

Good Automated Manufacturing Practice (GAMP) is one of the many FDA guidelines Windows OS supports. While multifaceted, one aspect of GAMP is the integrity of records and data through data governance. Data governance is defined by the MHRA as: 

“The sum total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained, and used to ensure complete, consistent, and accurate record throughout the data life cycle.” (Clark et al., 2017, p. 21)

It is composed of three main areas: technology, process, and people. Seen in Figure 2, each area is organized under its own controls that guide decisions for data integrity and security. 

 

Technical Controls

Technical controls prevent the unauthorized deletion or modification of regulated data and records via user access arrangements. Additionally, they preserve copies of data through a combination of backup and recovery processes and validated security controls (Clark et al., 2017, p. 19). Using a supported Windows OS sets the foundation for strong technical controls. It ensures the most secure access to and modification of data records, and that integrated controls cannot be evaded due to flaws in the software system. The installation of released updates to supported Windows OS is a key part of maintaining this security. In addition, upgrading to the newest editions of Windows OS provides access to the latest backup and recovery technologies, such as cross-platform connected devices and tools for the cloud.

Figure 2: Controls for Data Governance (Clark et al., 2017, p. 21)

Procedural Controls

Procedural controls minimize the risk to data integrity, identify the residual risk of following the principles of ICH Q9, and assess risk associated with third-party software (Clark et al., 2017, p. 19). While they relate to the processes that utilize technology rather than the technology itself, using a supported Windows OS is still important in maintaining these controls. Windows OS aids in the process of ensuring data integrity by inherently minimizing risk to it. Features like Windows Defender Antivirus help evaluate the safety and risk associated with third party software, in addition to the use of similar programs available.

 

Behavioral Controls

Behavioral controls relate to the maintenance and training for data integrity, the preservation of a work environment that promotes data transparency, and the ownership of data over its lifecycle. The maintenance of data integrity and preservation of data transparency are upkept through the protections and channels that are included in supported Windows OS functionality. While the ultimate ownership of data relates to the actions of the users that behavioral controls govern, Windows OS plays a key role in its protection through the data lifecycle.

 

The Data Lifecycle

The data lifecycle represents all phases of data from its initial creation to final destruction. Depicted in Figure 3, it contains five phases. A supported Windows OS ensures data integrity throughout each phase.

 

Data Creation

Data can be created manually through user input or via the use of an instrument or measuring device. Its integrity can be compromised at the point of creation by lacking appropriate accuracy, completeness, content, and meaning. Windows OS limits these risks by safely storing created data through properly authorized channels.

 

Processing

Data processing is the phase in which the required information is formatted and derived from created data. Though it varies by product and business process, data processing has a direct impact on product quality and patient safety (Clark et al., 2017, p. 35). Windows OS supports programs necessary for secure processing.

 

Review, Reporting, and Use

During review, reporting, and use, data is used for informed decision making, through defined and verified processes most typically related to record documentation. Windows OS serves as the foundation for appropriate data access during documentation activities.

 

Retention and Retrieval

Throughout retention and retrieval, data is readily available for any entity or regulator approved to review it. Windows OS protects stored data for the length of its retention period, as in accordance with defined and verified processes and approved procedures. 

 

Destruction

Data destruction occurs at the conclusion of the retention period, when all regulations for destruction are met and the data is completely cleared to be disposed. Given appropriate controls, Windows OS will not destroy data until properly authorized and protect against data destroying malware.

 

In this way, a device with Windows OS ensures only those with proper access can create, process, review, and destroy data. Working with the newest editions of Windows OS bolsters these functions through data management via cloud tools and other performance capabilities. 

Figure 3: The Data Lifecycle (Clark et al., 2017, p. 33)

 

Serialization

The Drug Supply Chain Security Act (DSCSA) provides regulations to help the industry identify suspect and illegitimate products in the prescription drug distribution system in the United States. A core practice that supports this legislation is serialization, a process to track and trace pharmaceutical drug products through the complete supply chain. This process identifies legitimate products at the unit, inner-pack, case, and pallet level of production and relies heavily on the security and integrity of data. From data protection to cross-platform access and storage via the cloud, Windows OS acts as a pharmaceutical company’s foundation for security and integrity throughout this process.

 

Upgrade Considerations

As in upgrading any system, there are important factors to be considered. Though it depends on age and configuration, most devices operating on Windows 7 or newer can be fully upgraded within an hour (Upgrade to Windows 10: FAQ, 2020). Pending on the age of a computer, in some instances, a new device will be required to upgrade to the newest versions of Windows OS. Additionally, some devices may require freeing up or acquiring additional storage space. Large-scale deployment of the latest editions of Windows 10 can be arranged through the use of the Microsoft Development Tool kit. For more information, view Microsoft’s Windows Update: FAQ.

 

Windows OS Maintenance 

Fortunately, once a device’s OS is upgraded to Windows 10, maintaining the software takes less effort than before. Without any work from the user, automated updates on the latest editions of Windows OS will install routine fixes and improvements as they are released by Microsoft. These updates can be scheduled within the Update and Security tab of the Settings menu. Details regarding updates available, and the most recent updates installed, can be viewed on this tab as well. While Microsoft sends notifications related to the end of a product’s lifecycle, the best resource to find information related to a specific Windows OS and the timeframe to upgrade to a newer edition is the Windows Lifecycle Factsheet

 

Conclusion

This guide explains the importance of a fully updated and supported Windows Operating System in the pharmaceutical industry, and the processes Microsoft follows to release improvements and phase out old software. Through these processes, devices running Windows OS receive the latest security features and performance improvements that protect the access, storage, and transfer of data. In compliance with Good Manufacturing Practices, Windows OS provides the infrastructure to uphold the latest pharmaceutical standards as well as international regulations and guidelines. The latest editions of Windows OS automate updates and emphasize timeframes to upgrade to new OS software, making such standards and practices easier to follow. Running devices and networks on a fully updated Windows OS with Microsoft Support will ensure the highest degree of software security and data integrity for a pharmaceutical company. 

 

References

Clark, C., Jones, C., Margetts, T., Newton, M., Perez, A., Reid, C., . . . Wingate, G. (2017). ISPE GAMP Records and Data Integrity Guide. Tampa, FL: ISPE.

Fixed Lifecycle Policy – Microsoft Lifecycle. (2019, September 19). Retrieved August 31, 2020, from https://docs.microsoft.com/en-us/lifecycle/policies/fixed

Grynoch, T. (2018). Data Lifecycle. Retrieved August 31, 2020, from https://nnlm.gov/data/thesaurus/data-lifecycle

Lindsay, G., Hall, J., Keller, L., Poggemeyer, L., Lich, B., Hernandez Avedon, M., . . . Mariano Gorzelany, A. (2020, August 13). Windows 10 deployment scenarios (Windows 10) – Windows Deployment. Retrieved August 31, 2020, from https://docs.microsoft.com/en-us/windows/deployment/windows-10-deployment-scenarios

Modern Lifecycle Policy – Microsoft Lifecycle. (2020, January 10). Retrieved August 31, 2020, from https://docs.microsoft.com/en-us/lifecycle/policies/modern

Title 21: Food and Drugs. (2020, August 28). Retrieved September 01, 2020, from https://www.ecfr.gov/cgi-bin/text-idx?SID=63804c565597c0de4c2f5628c5381d47

Upgrade to Windows 10: FAQ. (2019, July 29). Retrieved August 31, 2020, from https://support.microsoft.com/en-us/help/12435/windows-10-upgrade-faq

Warren, T. (2020, January 27). Microsoft Forced to Create a Free Windows 7 Update Just Days after Updates Ended. Retrieved September 01, 2020, from https://www.theverge.com/2020/1/27/21082228/microsoft-windows-7-black-wallpaper-fix-update-support-patch

What is WannaCry Ransomware? (2020, June 11). Retrieved August 31, 2020, from https://www.kaspersky.com/resource-center/threats/ransomware-wannacry

Whittaker, Z. (2019, May 12). Two years after WannaCry, a million computers remain at risk. Retrieved August 31, 2020, from https://techcrunch.com/2019/05/12/wannacry-two-years-on/

Windows Lifecycle Fact Sheet. (2020, August). Retrieved August 31, 2020, from https://support.microsoft.com/en-us/help/13853/windows-lifecycle-fact-sheet

Windows Update: FAQ. (2020, August 11). Retrieved August 31, 2020, from https://support.microsoft.com/en-us/help/12373/windows-update-faq

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Changes in Packaging and Serialization

As we exit past the ‘surprise and shock’ phase of Covid-19, there will be several factors to be monitored as new regulations, medicines and tracking requirements are discussed during the shift of the pandemic towards improved treatments and potential vaccines. Some states are showing a decline of cases and others areas with a more dense population are still heavily impacted as doctors and nurses travel in from other areas to help relieve fatigued health care workers and clinicians. Other industries have changed their focus to help aid efforts such as automobile factories shifting production to make face shields and even spirit distilleries making hand sanitizer. It is clear that this pandemic will have not only a great impact on health care but also many suppliers in various industries. 

 

One way to help with these changes is serialization. World Pharma Today sums up serialization as “a process in which a unique number is assigned and marked directly on a product or its packaging – typically achieved through barcoding technology. Serialization promotes item-level traceability and represents a departure from normal manufacturing processes whereby products are assigned to batches and lots. The theory behind serialization is that by assigning unique serial numbers to each product and introducing scanning at various points in the supply chain, the potential for counterfeit products to get through undetected is substantially reduced.” 

 

A few trends that we feel will be important to pay attention to as we move forward towards a new era of products and packaging and how serialization come into play:

 

  1. The authentication of medication: While there is much discussion and research towards a Covid-19 vaccine, medications to help treat side effects are just as important. This is especially true because of the great need of clinical treatments in demand and the amount of financial gain that counterfeit producers could potentially earn. Having a very efficient serialization process helps to keep the medicines secure and untampered.
  2. Food Supply packaging moving forward: Not only has the food supply been in high demand but the industry as a whole has been forced to adapt to a direct to consumer model. While some farmers are hurting because they have no way to get the food into the hands of customers directly, others, such as meat farmers, are able to sell out for weeks at a time. 
  3. Medical Device production & supply: Health care supplies have been in high demand since the beginning of the pandemic. We believe that there will be more standardized equipment plans even beyond medical facilities if a situation like this were to ever arise again. More regulation, protocols and a higher demand means that errors will need to be reduced and tracking improved. 

 

Achieving the goals of your company’s overall manufacturing and go to market strategy while maintaining compliance not only in times of need but every day is critical. RemTech’s serialization difference is the unique combination of technical services to address the understanding of the requirements, the compliance and regulatory expertise to develop an implementable strategy that meets compliance requirements and margin protection along with the project management skills to implement, validate and train on a safe, compliant, cost-effective solution. RemTech decreases downtime, increases productivity, reduces costs, provides better results and stable compliance and is a leader in serialization. We would like the opportunity to discuss further with you and your team on how we can help prepare you for the future. → Contact Us

Reference: https://www.worldpharmatoday.com/articles/authenticating-covid-19-vaccines-will-be-just-as-important-as-the-vaccine-itself/

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Serialization and Supply Chain in Times of Need

Now, more than ever, serialization and packaging are at the forefront of the COVID-19 epidemic. With the world’s best scientists rapidly working on developing a vaccination and treatment plan for this deadly virus, a large majority of the population are staying confined to their homes and shortages in grocery outlets are becoming normalized. The packaging and tracking of products will be absolutely crucial to the distribution chain during this time. Below are a few key elements that will directly impact the disease mitigation to society in relation to serialization.

  1. Tracking of healing medicine: If a vaccine or treatment medication is developed, it will be imperative that it is shipped, tracked and delivered as efficiently as possible. Proven serialization methods should be implemented to help manage the entire lifespan of the product from creation to ingestion. Not only will this impact the economic footprint of the drug but even more importantly, it will ensure the delivery process to the patients that are needing it most.
  2. Distribution of food supply: It is not uncommon to find grocery outlets (storefront and online retailers alike) to have shortages of daily staples such as toiletry products, foods such as beans, rice and pasta, and cleaning products. Serialization methods can help the supply chain to track real-time inventory so that those that are in need can have access to these important products.
  3. Conservation of packaging: When a global epidemic causes such a shift in balance affecting normal routines for millions of people, it can bring out so much positive comradery but unfortunately, also negative reactions. These negative reactions include counterfeiters and those who would be willing to take advantage of people in a time of need. Now more than ever, packaging of medicines and food supply need to maintain the highest quality packaging so that the integrity of items are not jeopardized.

Through any kind of situation that affects so many lives in such a short period of time, strengths and weaknesses of an organization are exposed. If your company is in the pharmaceutical, food supply or medical device industries, you could particularly be feeling an extreme amount of organizational stress relating to serialization and keeping things on track. As the leaders in strategic serialization implementation, RemTech can help decrease downtime, increase productivity, reduce costs, providing better results and stabilizing compliance.

If you have any questions, please contact John Hartwig at jhartwig@remtechllc.com and we would be glad to help!

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