Once again, we are proud to introduce you to another one of our consultants. This month we would like to shine a spotlight on our Director of Engineering, Jason Carpenter.
Since graduating from Tennessee Technological University with a Bachelor of Science in Manufacturing and Industrial Technology, Jason has worked as a Project Engineer in various roles in the pharmaceutical and industrial manufacturing industries. Throughout his career, he has managed multiple construction projects and process improvement projects for different firms. Now, in his position as Director of Engineering for RemTech, Jason focuses on facility and process support for pharmaceutical manufacturing operations.
One of the things that Jason appreciates about his position is the wide variety of projects, locations, and clients that he has the opportunity to work with. While the project types and locations may change, one thing that remains consistent is his approach to each project. The first things that Jason looks at with a new project are organization and communication. Each is vital for any project, without proper organization and communication the project will struggle to stay within the parameters of the scope, schedule, and budget.
Jason is a valuable asset to our organization and he is a leader in his own community. Jason volunteers and holds positions of leadership in multiple organizations in his hometown. While he values his career and the volunteer work that he does, the most important job he has is as a husband and father. He loves spending time camping and enjoying the great outdoors with his family and friends.
At RemTech, we understand that our consultants make us who we are. Jason Carpenter is an indispensable part of our team and brings a unique set of skills to serve our clients. We are proud of our consultants and know that they have the skills and knowledge to lead our clients to success. Contact us today to see what our consultants can do for you!
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.
Peanut butter and jelly, Simon and Garfunkel, rhythm and blues. Some things are just better together. Add one more to the list: RemTech and Triad Unlimited. RemTech has partnered with Triad to bring superior program packages to better serve our clients. Each team brings specialized areas of focus to the table to create a better-equipped partnership to serve you and your organization.
Triad is a professional Asset Management Practitioner Consultancy Firm possessing a portfolio of collective global projects for a multitude of industrial customers. The scope of their products and services are in Life Cycle Asset Management, Maintenance, Reliability Engineering, and Long-Term Capital Planning Analysis in support of Operational Excellence. Triad utilizes their proven Asset Management Framework, cloud-based Learning Management System, and RelialtyicsTM which is their leading-edge proprietary technology for data analytics. Triad approaches every project focused on integrity, extraordinary value, clear communication, and on-time delivery.
Triad’s core services include an Asset Management Gap Analysis and Improvement Plan (AMGAIP) that addresses optimizing Operating Investment for Operational improvement and A State of Good Repair (SGR) Analysis that addresses optimizing Capital Investment.
Triad’s AMGAIP Technology Tool, aligned with its framework, provides quick and optimal navigation through 240 analysis points for risk-based program evaluation. The AMGAIP Report deliverable is a data- and analysis-rich document that provides a summary of the overall program gaps, details of program risk, and serves as a mechanism in selecting key areas of focus and support for prioritized improvement. The AMGAIP Roadmap is constructed on an engineering project plan platform with individual tasks that include sequencing, dependency, assignment, due date, qualification, and duration requirements. This ensures the plan is actionable and measurable in support of a successful implementation. The results are a multi-phased detailed budget and results-focused action plan that includes roles and responsibilities (RACI) of identifying “who implements what” and “how” it is to be implemented.
Maintaining your site network infrastructure in a State of Good Repair is mission-critical to sustain a reliable and efficient supply chain. Triad performs risk-based SGR analysis for a variety of manufacturers across the globe. SGR exists when a pre-defined percentage of site assets are within their useful life, parts obsolescence is being managed, and assets are performing at their designed function. An SGR Vulnerability Analysis begins with analyzing any gaps within your essential physical infrastructure program elements: Engineering, Capital and Maintenance Strategies, Business Processes, and Implementation Plan. This Vulnerability Analysis enables the development of a remediation plan to be addressed via Long Term Capital Planning, Maintenance Strategies, and Asset Operator Care. Together with the AMGAIP, this completes the “Big Picture” understanding of how the assets arrived at their current Physical State Condition and overall State of Good Repair.
After Triad identifies the areas of opportunity and applies the tools to manage the assets, RemTech has the practical knowledge to implement process-related solutions for clients. This means that RemTech can take issues identified by Triad and link those issues to Critical Quality Attributes and develop ways to control and monitor the corresponding Critical Process Parameters. RemTech consultants specialize in project management, serialization, automation, validation, etc. to ensure your project is completed in an efficient and cost-effective manner.
While each team is successful in their respective areas, partnering together provides a new level of service and experience to every project. By developing program packages that combine the strengths of these two companies, we can offer our clients a custom-built plan that includes the best practices and the best usage of their assets and processes.
Triad offers life cycle asset management services with a focus on cost performance, investment optimization, and program risk. RemTech focuses on project management through validation, serialization, compliance, and regulatory support. Together, our companies can offer you the best opportunities that fit your organization and your needs.
Learn more about Triad at www.triadunlimited.com.
Contact us today to see how the partnership between RemTech and Triad can benefit you.
The RemTech Difference
There are many consultants out there but none like the RemTech consultant. Our team of professional consultants can make the impact that you are needing. We take pride in leading the industry in technical services, compliance, and project management. Here is what makes our consultants different.
Our consultants are skilled in a variety of technical areas to ensure your needs are met. We have experienced manufacturing and business management professionals that are focused on your success. Our team strives to provide you with effective solutions to even the most challenging issues.
Compliance & Regulatory
One of the most important aspects of our business is staying current in industry trends and regulatory compliance. RemTech consultants can guarantee that your business falls within the bounds of all federal, state, and local regulations. We have a “right-first-time” approach that is highly cost-effective and streamlines your success.
Whether you are upgrading your production system, building a new facility, researching and purchasing new equipment, or starting another new project, our consultants specialize in project management. We will work with your team to make sure your project is completed in an efficient manner. You can trust RemTech consultants to manage projects for you so you will be free to focus on other aspects of your business.
When you partner with RemTech, you get more than just a consultant. You get a team with decades of knowledge and experience. We put that knowledge and experience to work for you. Our success is measured by your success. Ensuring your satisfaction is our goal and we won’t rest until the job is done.
Contact us today to see the difference that RemTech can make.
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.
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.
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.
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.
Upgrading Windows Operating System
Ensuring Data Integrity through Optimal Security and Performance
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.
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 Systems||Mainstream Support End Date||Extended Support End Date|
|Windows 10 Enterprise LTSC||January 9, 2024||January 9, 2029|
|Windows 10 Enterprise 2016 LTSB||October 12, 2021||October 13, 2026|
|Windows 10 Enterprise 2015 LTSB||October 13, 2020||October 14, 2025|
|Windows 8.1||January 9, 2018||January 10, 2023|
|Windows 7, service pack 1||January 13, 2015||January 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 Systems||End of Service for Home, Pro, Pro Education, and Pro for Workstations Editions||End of Service for Enterprise and Education Editions|
|Windows 10, version 2004||May 27, 2020||December 14, 2021|
|Windows 10, version 1909||November 12, 2019||May 11, 2021|
|Windows 10, version 1903||May 21, 2019||December 8, 2020|
|Windows 10, version 1809||November 13, 2018||November 10, 2020|
|Windows 10, version 1803||April 30, 2018||November 12, 2019|
Table 2: Key Modern Lifecycle Dates for Windows OS
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)
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 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 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 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 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.
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.
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)
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.
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.
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.
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.
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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/
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The success of your business is your first priority. On the road to success, the first thing to consider is your footing. Whether you are talking about archery, marksmanship, sports, or business, if your footing is not secure then your aim will be off. Making sure you have a solid foundation is the first step to success.
RemTech is that solid foundation. At RemTech, our consultants are experienced professionals that will work with your company to set you on the road to success. With our serialization and automation experience, we will not only increase your company’s accuracy but also reduce cost and make sure you are compliant with current laws, regulations, and best practices.
Serialization helps an organization track products and know where each individual item ends up. This process helps companies maintain shipping accuracy as well as providing excellent customer service. Your clients can rest easy in the knowledge that each item from your company is traced from manufacturing to distribution.
Another benefit of serialization is product authenticity. Utilizing serial numbers on your product helps to maintain integrity and protects the market from fraudulent products. Serial numbers are more difficult to counterfeit and provide better protection for your product and your brand.
Serialization is one of our specialties. Through our serialization services, your company can better maintain a chain of possession. We will develop a system that reflects the needs of your business and work with you to achieve the goals for your business and clients.
Serialization is the foundation that your company needs. RemTech can provide your company with that foundation and make sure you are on the road to success! Contact us today to find out more!