ITS All About Regulations and Modernisation

Welcome to the latest edition of the Industrial Technology Systems (ITS) newsletter. Can you believe its been four weeks since our last publication.?

We are thrilled to announce the launch of our Life Sciences showcase page, dedicated to providing insights and solutions tailored to the unique challenges faced by this dynamic industry. Our aim is to bring like minded people together to discuss latest trends, problems and solutions.

In this month's edition, we delve into a variety of compelling topics that touch upon the critical role of technology in regulated industries. Our first article, "The High Cost of Obsolete Systems: How to Evaluate and Modernise Technology in Regulated Industries," explores the implications of outdated systems and offers valuable guidance on assessing and upgrading technology to stay competitive and compliant.

We shed light on the ever-evolving UK regulatory landscape with our article, "UK Regulatory Oversight: What to Expect from GMP Non-Compliance Statements and IAG Letters." This piece delves into the intricacies of compliance and provides insights into the expectations and implications surrounding GMP non-compliance statements and IAG letters.

Recognising the importance of staying abreast of regulatory changes, we present "Gain a Competitive Edge in Life Sciences Regulatory Compliance with Our Specialised Training Courses." This article highlights our training programs designed to equip professionals in the life sciences sector with the knowledge and skills required to navigate complex regulatory frameworks effectively.

We also ?share a post-event piece on Chem UK, a prominent gathering of professionals from the chemicals, processing, and supply chain industries. Dive into our recap, capturing the key highlights and takeaways from this noteworthy event.

Last but not least, we provide a sneak peek into the exciting upcoming events in our industry. Stay tuned and mark your calendars for these enriching opportunities to network, learn, and explore the latest advancements in industrial technology.

We hope you find this month's newsletter engaging and informative. As always, we value your feedback and encourage you to reach out to us with any questions or suggestions. Enjoy the read!

The High Cost of Obsolete Systems: How to Evaluate and Modernise Technology in Regulated Industries

With the recent announcement of the S7-300 range being retired from October 2023, we thought it would be useful to discuss obsolescence. The life sciences, chemicals, and power and energy industries are heavily regulated, with strict standards and regulations in place to ensure safety, efficiency, and compliance. However, these industries also rely heavily on technology to support their operations, and outdated or obsolete systems can pose significant risks and challenges. To address this issue, it's essential to ask the right questions when considering potentially obsolete systems in regulated industries.

When evaluating potentially obsolete systems, here are some questions to consider:

·???????What is the current state of the system, and how long has it been in place?

Understanding the current state of the system is essential to identify potential risks and challenges.

·???????What are the specific regulations and standards that the system needs to comply with, and how are they currently being met?

The system should be in compliance with all applicable regulations, and any potential gaps should be identified and addressed.

·???????What are the critical functions of the system, and how do they support the operations of the business?

?Understanding the critical functions of the system can help identify areas where updates or replacements may be necessary.

·???????What is the maintenance history of the system, and how often has it required repairs or updates?

?Understanding the maintenance history of the system can help identify any potential issues that may arise in the future.

·???????What is the impact of system downtime or disruptions on the business?

Downtime or disruptions can have a significant impact on operations, and understanding this impact is essential to developing a strategy to minimize potential downtime.

·???????Are there any safety concerns related to the current system, and how are they being addressed?

Safety is paramount in regulated industries, and any potential safety concerns should be identified and addressed promptly.

By asking these questions, businesses can identify potential risks and develop a strategy to address them. However, addressing these challenges can be challenging, and many businesses may require the assistance of a third-party provider to help modernise their technology and stay compliant with regulations.

ITS is a leading provider of technology solutions for regulated industries, including life sciences, chemicals, and power and energy. Our team of experts can help businesses assess their current systems, identify potential risks, and develop a plan to modernise their technology and stay compliant with regulations.

If you're facing challenges with potentially obsolete systems in regulated industries, we encourage you to contact ITS. We'll be happy to answer any questions you may have and help you develop a plan to address your unique needs. Together, we can ensure that your systems are up to date, efficient, and compliant with the latest regulations. Contact ITS today to learn more.

UK Regulatory Oversight: What to Expect from GMP Non-Compliance Statements and IAG Letters

This month, we delve into an important aspect of regulatory oversight in the United Kingdom—the GMP Non-Compliance Statement or Inspection Action Group (IAG) Letter—and discuss how it impacts facilities involved in the manufacturing, testing, and distribution of products, including pharmaceuticals, medical devices, and food.

Understanding the GMP Non-Compliance Statement or IAG Letter:

When the UK conducts inspections of facilities, their primary goal is to ensure the safety and efficacy of products. During these inspections, if regulatory violations are identified, inspectors issue a GMP Non-Compliance Statement or IAG Letter. It is important to note that this form is not a formal warning or citation but serves as a list of observations made by inspectors.

The Purpose and Consequences:

The GMP Non-Compliance Statement or IAG Letter acts as a means to inform facility management about regulatory violations detected during inspections. While it does not carry immediate legal ramifications, failure to promptly and effectively address the issues identified can lead to serious consequences. The UK may escalate regulatory action, such as issuing warning letters or initiating legal measures.

Furthermore, it's worth noting that these letters become a matter of public record and can be obtained by the public through a Freedom of Information Act (FOIA) request. Consequently, the issuance of a GMP Non-Compliance Statement or IAG Letter can have adverse effects on a company's reputation, potentially resulting in decreased investor confidence or stock prices.

Responding to the GMP Non-Compliance Statement or IAG Letter:

Facilities that receive a GMP Non-Compliance Statement or IAG Letter must take immediate action to address the identified issues. A thorough review of the observations is crucial to determine the necessary steps for rectification. Conducting a root cause analysis helps identify underlying causes, enabling the development of a comprehensive corrective action plan to prevent future violations.

Effective communication with the UK regulatory authorities is essential. Facilities should promptly inform the UK about the corrective actions being undertaken and provide documented evidence of their progress in resolving the violations. This transparent and diligent approach showcases a commitment to compliance and mitigates any negative impact on the facility's reputation.

ITS: Your Partner in Compliance

At ITS, we understand the significance of maintaining regulatory compliance and the challenges that come with it. With over thirty years of experience, we have developed a wealth of knowledge and expertise to assist companies in addressing regulatory violations identified in both FDA 483s and UK's GMP Non-Compliance Statements or IAG Letters.

Our comprehensive solutions automate key quality processes, such as document control and employee training, ensuring that all employees stay informed about the latest regulatory requirements and company policies. By partnering with ITS, you can streamline your compliance efforts, mitigate risks, and demonstrate your commitment to maintaining the highest standards of quality and safety.

Take Action Today!

If your facility has received a GMP Non-Compliance Statement or IAG Letter, don't delay in seeking the support you need. Contact ITS to discuss how our tailored solutions can assist you in addressing regulatory violations, maintaining compliance, and safeguarding your company's reputation.

Remember, by promptly and effectively addressing regulatory violations, you can prevent more serious regulatory actions and uphold your commitment to providing safe and effective products to the market.

Gain a Competitive Edge in Life Sciences Regulatory Compliance with Our Specialised Training Courses

In the dynamic and highly regulated world of life sciences, maintaining compliance with ever-evolving regulatory requirements is essential. Non-compliance can jeopardise patient safety, hinder product approvals, and result in severe financial and legal consequences. For two decades, ?ITS has successfully delivered a ?range of Training Courses in Life Sciences Regulatory Compliance, courses are designed to empower your organisation with the knowledge and expertise necessary to navigate this intricate landscape successfully.

Why Choose Our Specialised Training Courses?

Industry Expertise: Our trainers are seasoned professionals with extensive experience in life sciences regulatory compliance. They possess a deep understanding of the complex regulatory frameworks governing pharmaceuticals, medical devices, biotechnology, and clinical research.

Courses can be Tailored to Your Needs: We recognise that each segment of the life sciences industry has unique compliance challenges. Our training courses can be tailored to address your specific requirements.

Current and Comprehensive Content: Our courses provide a comprehensive overview of global regulations and guidelines, including FDA, MHRA, and other pertinent authorities. We incorporate the latest updates and emerging trends, ensuring your teams stay informed and compliant with the most recent regulatory changes.

Practical Application: Our training programs go beyond theoretical knowledge, emphasising practical application. Through interactive workshops, case studies, and simulated scenarios, we enable participants to apply regulatory concepts to real-world situations, enhancing their problem-solving skills and critical thinking abilities.

Available Training Courses:

Equip your organisation with the necessary knowledge and skills to thrive in the highly regulated life sciences industry. Take advantage of our specialised training courses in life sciences regulatory compliance. Contact us today at 01642 222232 or visit our website https://www.its-ltd.co.uk/course/calendar to explore our comprehensive range of programs and schedule a consultation with our expert trainers.

Remember, compliance is the key to patient safety, product success, and maintaining a competitive edge in the life sciences landscape. Let us guide you towards regulatory excellence.

Forging Connections at Chem UK

ITS's participation at Chem UK provided an exceptional platform to engage with industry professionals, chemical manufacturers, and decision-makers. The exhibition served as an opportunity to demonstrate their ability to drive operational efficiency, safety, and sustainability in the chemical sector.

We are grateful for the enthusiastic feedback and interest received from attendees. The event reaffirmed ITS's position as an industry leader that addresses the evolving needs of the chemical industry.

Moving forward, Industrial Technology Systems Ltd remains committed to pushing the boundaries of innovation, collaborating with industry partners, and supporting the chemical sector's journey towards a digitally-driven and sustainable future.

Thank you to all who visited our exhibition stand ?and expressed interest in working with us. We look forward to further discussions and partnerships that will enable us to continue driving progress in the chemical industry.

Anticipating the Future: A Preview of Upcoming Events

Join ITS on the Road at the upcoming Exhibitions!

ISPE UK Annual Exhibition - 30th November 2023 - Coventry Building Society Arena

Whether you are an industry professional or simply interested in the latest ITS services, the ITS exhibition stand at ISPE is not to be missed. Join us to discuss your upcoming projects.

Unlocking Possibilities: Join us and our Partners at our Open Days Events!

Walking amongst Cobots in the Age of Industry 5.0 – 22nd June 2023

Cobots are transforming industry, explore interactive displays, witness cobots in action, and engage in discussions with lndustry Leaders. Our Open Day event provides a unique opportunity to witness these intelligent machines in action, learn about their numerous applications in various industries. Discover how they can optimise your operations and help you stay ahead of the competition. Don't miss out on this exciting opportunity to explore the present and future of industry!

Get your tickets now: https://www.eventbrite.com/e/walking-amongst-cobots-in-the-age-of-industry-50-tickets-601382640667

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Stay Ahead of Cyber Threats with Expert Insights and Revolutionary Security Tech–

Cybersecurity is one of the current hot topics, so why not get ahead of cyber threats and join ITS and Radiflow at one of our open days and discover the latest security tech with industry experts!

Whether you're a cybersecurity professional or simply someone interested in the field, our upcoming open days with Radiflow are the perfect opportunity to stay ahead of the game. Join either event which will be?filled with engaging presentations, hands-on demos, and networking opportunities. Meet with experts in the industry and learn about the latest cutting-edge technology designed to protect your business from cyber threats. Don't miss out on this exciting chance to connect with like-minded individuals and take your security knowledge to the next level. Sign up now and get ready to outsmart cybercriminals!

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Building Resilience against Cyber Threats – 13th July 2023 – Cambridge

Get your tickets now: https://www.eventbrite.com/e/building-resilience-against-cyber-threats-cambridge-tickets-619865162387

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Building Resilience against Cyber Threats – 14th July – North West

Get your tickets now: https://www.eventbrite.com/e/building-resilience-against-cyber-threats-north-west-tickets-619896355687

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Independent system integrator ITS Ltd is a leading provider of system integration services for a wide range of industries, including Life Sciences, Chemical Manufacturing, and Power and Energy. With over 30 years of experience in industry, ITS Ltd has a proven track record of delivering high-quality, reliable solutions to its clients.

Overall, ITS Ltd aims to be your trusted partner providing reliable, high-quality system integration services to help you achieve your business goals in your high performance, highly regulated environments.