Industries
Life Sciences
Pharmaceutical & Biotechnology at ITS
ITS has been providing systems and support to the pharmaceutical industry for over 30 years, and our extensive experience allows us to provide expert solutions for various challenges in the Life Science space.
We specialise in providing pragmatic and value-adding solutions for control or management information systems, compliance, or specialist data analysis requirements.
Our expertise in the pharmaceutical industry includes involvement in the developments of GAMP® from v1 to v5, and we have actively participated in several ISPE SIG groups over the years.
Our Expertise in Life Sciences
ITS has been providing systems and support to the pharmaceutical industry for over 30 years. We have been involved in the developments of GAMP® from v1 to v5, including additions like 21CFR11 compliance, serialisation, and data integrity.
Our own Quality Management System (QMS) is based on GAMP®5 principles, and we are both experienced and pragmatic in our delivery. As the biotech/biopharma industry has grown, so has our knowledge and involvement in it from a regulatory point of view.
With our active involvement in several Special Interest Groups (SIG) and Communities of Practice (CoP), we ensure your project is validated to the highest standards, pragmatically.
Services
Regulated Industry Automation Solutions for Life Sciences
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Business Operational Solutions
At ITS, we specialise in customised business operational solutions tailored to the needs of Life Sciences, Pharmaceuticals, Medical Devices, and Biopharma industries. Our seasoned specialists excel in delivering cutting-edge solutions that optimise processes, elevate decision-making capabilities and drive corporate success.
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Management Information Systems
Our team understands the critical importance of real-time, accurate data in informed decision-making across Life Science sectors. We provide advanced management information systems that empower clients with efficient data management, analysis, and reporting capabilities.
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Process Control Systems
Our specialised process control services are crafted to enhance operational performance and efficiency in the Pharmaceuticals, Medical Devices, and Biopharma sectors. We seamlessly design, implement and maintain customised control systems, utilising cutting-edge technologies to deliver dependable and efficient solutions.
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Project Management & Engineering Services
In Life Sciences, Pharmaceuticals, Medical Devices, and Biopharma, we understand the distinct character of each project. Our APM-registered project management and quality engineering services precisely match your needs. Whether you need outsourcing or in-house support, our flexible solutions guarantee project success.
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Vision Systems
At ITS, we understand the critical importance of precise process control in Life Science sectors. Our automated Vision Inspection and RFID tracking solutions save time and resources. With seasoned professionals, we excel in crafting, implementing and sustaining tailored vision systems.
MORE INFOYour Trusted Partner for Medical Device Compliance and Expertise
ITS’ Impact in the Medical Device Sector
ITS has been involved in the Medical Device sector since 1996, starting with providing expertise to several Med Dev companies who were facing increased demands from their pharma partners to follow the new automated manufacturing practices that became GAMP®.
Our extensive experience of GAMP, combined with our knowledge of and adherence to the separate MDR regulations allowed us to provide expertise and solutions that helped our customers through the various challenges.
Providing resources to help specify and perform testing, led to ITS replacing several assembly line control and monitoring systems including the replacement of several vision systems which were not performing as required.
We also provided consultancy for the customer with its suppliers so they would understand the increasing demands, and finally training for our customers staff so that they might design and build systems in the future that would meet the increasing standards more readily, without our intervention.
INDUSTRIES
Seamless Integration for Highly Regulated Sectors
ITS offers consultancy services to help our clients achieve compliance with industry standards and regulations. We can work with your team to identify gaps in your current processes and provide expert advice on how to address them.
Our consultants have extensive experience in the pharmaceutical and biotech/biopharma industries and can help you navigate the complex regulatory landscape. ITS offers ongoing compliance and advice services to ensure that our clients remain compliant with industry standards and regulations.
The team at ITS can work with your BAU team to provide expert advice and support on an ongoing basis, allowing you to focus on your core business activities. Our primary mission is to assist companies operating in heavily regulated sectors in addressing distinctive regulatory hurdles, such as compliance and quality management.
Therefore, we excel in vertical markets, encompassing pharmaceuticals, biotechnology, chemicals, energy, nuclear, manufacturing, and various other industries.
DIGITAL BROCHURE
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FAQ
Here to Help Streamline Your Process in Life Sciences
To help answer any questions you may have, we’ve compiled a list of frequently asked questions to provide you with the information you need to make an informed decision about working with ITS.
How long has ITS been providing systems and support to the pharmaceutical industry?
ITS has been serving the pharmaceutical industry for over 30 years. ITS specialises in providing pragmatic solutions for control or management information systems, compliance, and specialist data analysis requirements within the Life Science sector.
Can you elaborate on ITS's involvement with GAMP® developments and ISPE SIG groups in the pharmaceutical industry?
ITS has actively participated in the development of GAMP® from version 1 to version 5, including additions like 21CFR11 compliance, serialisation, and data integrity. Additionally, ITS has been actively involved in several ISPE Special Interest Groups (SIG) over the years, ensuring expertise in industry standards and best practices.
How does ITS ensure compliance and quality in its services for the pharmaceutical and biotech/biopharma industries?
ITS follows its own Quality Management System (QMS) based on GAMP®5 principles, recognised as the industry standard for automated systems and validation. This commitment to quality enables ITS to deliver pragmatic and value-adding solutions tailored to clients' specific needs while maintaining the highest standards of compliance.
What specialised solutions does ITS offer for the biotech/biopharma industry?
ITS specialises in providing solutions for control or management information systems, compliance, and specialist data analysis requirements within the biotech/biopharma industry. The company actively participates in several Special Interest Groups (SIG) to stay up to date with the latest trends and developments, allowing them to offer customised, compliant solutions to clients.
Could you explain ITS's consultancy services for achieving and maintaining compliance with industry standards and regulations?
ITS offers consultancy services to help clients identify gaps in their processes and provide expert advice on addressing them. The experienced consultants at ITS, with a strong background in the pharmaceutical and biotech/biopharma industries, assist clients in navigating the complex regulatory landscape. Additionally, ITS offers ongoing compliance and advice services to ensure continuous adherence to industry standards and regulations.
How does ITS support medical device manufacturers in meeting regulatory requirements?
With over 30 years experience in Pharmaceuticals and 25 years in the Medical Device industries, ITS is a trusted partner for Pharma and is well-versed in the requirements for the 510k program and keeps up to date with evolving regulatory requirements. ITS is dedicated to delivering UDI solutions in compliance with the EU MDR 2020, including 2D Data Matrix and GS1-128 codes, and is attentive to other potential issuing agencies like HIBCC and ICCBBA coding. ITS offers solutions including management information systems and specialist data analysis requirements to ensure successful project outcomes for its clients.
How does ITS work with clients to provide ongoing compliance and support services?
ITS collaborates closely with clients and their Business as Usual (BAU) teams to offer ongoing expert advice and support, allowing clients to focus on their core business activities. With over 25 years of experience in the industry, ITS is a trusted partner for medical device compliance, providing specialised expertise and staying up to date with regulatory requirements, ensuring that clients remain compliant with industry standards and regulations.
UPCOMING TRAINING COURSES
Check out what training is happening next.
18/12 2024
IT Infrastructure Control and Compliance Training
Duration: 1 Day
Attendee Slots: 10 Places Left
19/12 2024
19/12 2024
Understanding Corrective and Preventive Action Systems (CAPA) Training Course
Duration: 1 day
Attendee Slots: 10 Places Left
At ITS we have more courses and dates available please see the full calendar.
ITS has provided a sound, mature project manager who has provided the necessary expertise to ensure that good operating practice is an integral part of our efforts to provide IT services to our new Corporate HQ.
Thank you for a thorough examination of the documents.
The performance of our labeling machine was causing a bottleneck for one of our packing lines. ITS identified the root cause of the problem, provided a solution, and most importantly, tested it thoroughly before handing the job back. The result was the removal of the bottleneck and the packing machine running at a higher speed.
Very competent in their approach and project delivery.
Broad range of experience.
I would unreservedly recommend to any company, contemplating venturing into the pharmaceutical industry, that they contact Industrial Technology Systems Ltd in the first instance.