ITS Ltd experience in the pharmaceutical sector started nearly 30 years ago. Since 1991 we’ve grown as a business providing systems and support to the pharms industry. We started in the GxP era, pre GAMP® and have been involved in the developments of GAMP® from v1 to v5, including additions like 21CFR11 compliance and Serialisation, Data Integrity and have had an active involvement in several ISPE SIG groups over the years too.
Our own QMS is based around the GAMP®5 principles and we are both experienced and pragmatic in our delivery, you get what adds value and not documentation for the sake of documentation.
As the biotech / biopharma industry has grown, so too has our knowledge and involvement in that from a regulatory point of view, but also, from a ‘value adding’ solutions delivery too. Be it a control or management information system, compliance or specialist data analysis requirement, we add value.
Our knowledge of good practice requirements, of the 510k program and the changing requirements of the regulations authorities since 1997 when the FDA provided its De Novo classifications for Medical Devices and allowed the use of previous device data analysis to support subsequent device submissions. This allowed ITS Ltd to become engaged in the medical device industry around 1997.
Our more recent work in the industry has seen us involved in delivery of UDI solutions. In order to meet the latest EU MDR 2020 which will require that 2D Data Matrix and GS1-128 codes to be used going forward. Other issuing agencies with potential for the use of HIBCC and ICCBBA coding will be available in the future it is expected.
ITS Ltd looks to add value from a solution delivery view, be it a control or management information system, or specialist data analysis requirement, we look to add value.
ITS Ltd, together with other partners, known to the industry, means we can be on the road to a successful project together.
With a chemical engineering background and years of experience working for UK and global chemical manufacturers, ITS’ background is steeped in the chemical processing industry.
The range of solutions ITS has provided over the last 30 years range from process control of large-scale continuous processes for basic and intermediate chemical products and materials, to batch processes of speciality chemicals. Our systems are found in plants making useful products and materials including petrochemical and plastics, inorganics and fertilisers, paints and coatings and detergents and personal care products.
So from PLC through to DCS type applications on the hardware side and S88 /S95 compliant software systems where required, ITS Ltd has designed and built complete process plants, vessels pumps pipework and E&I systems and cabling from the ground up, from one company who takes its safety and CDM responsibilities seriously.
In today’s chemical world, like so many others, data is king and ITS Ltd has designed and built real time monitoring and reporting systems which link to ERP systems to automatically transfer plant production data to enable plant staff and management to make better decisions based on a single set of true values and analysis points.
ITS have delivered a range of solutions for the Power Generation & Gas industry throughout our history for systems supporting local power generation, large central power generation for nuclear, gas and renewables (solar, wind and combined heat & intelligent power CHiP systems). We also provide solutions for national grid gas transmission pressure let down systems.
Our systems range from control systems using PLC / SCADA, Process Safety and Process Fire & Gas systems and Management Information systems.
Our systems control and manage your process to ensure that they operate safely, connect and disconnect to the grid, shed load so that only essential loads are connected when running on a standby generator system, and provide control and monitoring of standby generator systems to ensure that backup power continues to be available in the event of loss of the national grid. We have significant experience of working with IEC61850 (Intelligent Switchgear) connectivity.
Since 1998 ITS has performed projects in the nuclear decommissioning field. Projects ranging from installing additional safety functionality requirements on existing systems, creating replacement systems based on supportable hardware and software platforms or the reverse engineering and replacement of main control functions, all have been within the demands placed on ITS over the intervening years.
Our fundamental capability to deliver high quality, fully documented, control, monitoring and vision systems have been key to our success in the nuclear sector.
Over the years many in the nuclear industry have looked at our pedigree for high quality project management and project execution and inspected our QMS. People have recognized that this QMS meets all the requirements of a good quality practice required by the nuclear industry itself.
Our experience provides ITS with the ability to be both High Quality and Pragmatic at the same time and that maintains the integrity of operation and change control for which the nuclear industry is rightly proud with the pragmatism of just the right amount of evidence of control and management.
Since building started to be created with building management systems installed in them there has been a desire to maintain them well. In the last 10 years that had seen a monumental shift from ‘routine’ to ‘predictive’ maintenance and more recently to ‘smart buildings’ in which the building tells the owner when and what maintenance it needs.
More recently occupier ‘wellbeing’ and ‘comfort’ have been added to the mix and a drive to have the building cooperate with its tenants to provide them with the most efficient and cost effective environment in which to work. ITS has a range of “Smart Building” alternatives.
Modelling of equipment performance has been around for many years, but latest advances in data manipulation / analysis and storage software, along with a plethora of low cost cloud ready IoT devices etc. have led to the possibility to model large scale entities such as entire buildings or process plants, as well as giving us even more accurate equipment performance modelling.
The added advantage of this creation of a digital twin of the real world entity is that we can now review the effect of the changes we’d like to make, digitally – reviewing the results before making any physical or costly change. Our Digital Twin software can provide you with these advantages.
Many of our customers manufacture ‘products’ that can be single process steps or complex assembly processes, with verification at each stage to avoid adding valuable components to a ‘product’ that has already failed an earlier step and is destined to be reworked or scrapped.
Our systems prevent waste, save money and help to identify points of failure so that your hard earned money is spent wisely, things like OEE might add some real insight to your operations too and if we believe they will we’ll explain why and give you some Value Propositions. Our aim is to identify and fix the things that need to be fixed – in order to add greater value to your operation.
ITS involvement in the food industries over the years has been based around confirmation of product quality – inspection systems including vision systems confirming acceptable product appearance to laser measurement systems for product size / dimensions are all part of the ITS provision in to the food sector.
From full Airport Information Management Systems [AIMS], providing operational awareness of all aspects of the airports operation to Hold Baggage Screening [HBS] and Baggage Handling Systems [BHS] and small airport SAC systems.
JMP
JMP is a suite of computer programs for statistical analysis developed by the JMP business unit of SAS Institute. It was launched in 1989 to take advantage of the graphical user interface introduced by the Macintosh. It has since been significantly rewritten and made available for the Windows operating system.
JMP comes in a range of flavours including JMP®Live, JMP®Clinical and JMP®Genomics.
JMP® Data analysis software is used by hundreds of thousands of data explorers worldwide. Interactive and visual, JMP reveals insights that raw tables of numbers or static graphs tend to hide.
Innovation
Each year ITS Ltd staff undertake £150,000 - £200,000 worth of Research and Development activity. ITS is a willing partner in R&D undertakings with other partners too and always looking to enhance our R&D offerings for novel and challenging projects.
Currently ITS Ltd is lead partner for a ~£3m InnovateUK funded food safety project with 2 other commercial partners and 2 major UK universities and a world renown institute which makes major contributions to the understanding of key global issues, such as food, energy and environmental security.
Cyber Security
ITS Ltd is proud to be the partner for Radiflow technology in the Pharmaceutical and Chemical industries.
Radiflow’s iSID Detection & Analysis Platform provides proactive cybersecurity for critical infrastructures through non-intrusive monitoring of distributed production networks for changes in topology and behavior networks for changes in topology and behavior.
iSID’s multiple security engines offer capabilities pertaining to specific type of network activity: modeling and visibility of OT and IT devices, protocols and sessions; detection of threats and attacks; policy monitoring and validation of operational parameters; rules-based maintenance management; and networked device management.
iSID employs Radiflow’s iSAP Smart Collectors, installed at distributed networks’ remote sites, to collect, compress (to prevent network overload) and send over GRE all LAN traffic from the local switch, using port mirroring to a centrally installed iSID over VPN tunnels.
iSID allows for different modes of deployment, allowing organizations to optimize their cyber-security expenditure: on-site at the industrial (ICS/SCADA-based) facility; at the operator’s central monitoring location; or at an MSSP’s SOC (Security Operations center) using the iCEN management platform for multiple instances of iSID.
Over the last 14 years ITS Ltd has been providing high quality training courses for GxP and GAMP® compliance. Every course ends with a customer survey questionnaire and our customer satisfaction levels are always very high, with many customers going on to recommend ITS to their QA department, so that ITS performs on-site training for a greater number of their colleagues. Many of our customers send other members of staff on the same or other training courses from the list of courses available and as customers move on, they take the ITS Ltd training recommendations with them to their new employers.
We also provide technical training for our customers too, PLC, MES and Vision Systems training are another speciality from ITS Ltd staff and again, satisfaction levels, repeat business, recommendations and referrals are the normal customer responses.
Why not check out the courses? Open Training, On-Site training and virtual training are all available.
"Great Training is worth its weight in gold."
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