The pharmaceutical industry is highly regulated, and requirements are becoming stricter all the time. This is forcing pharmaceutical companies to be increasingly meticulous in the way they check, measure and report on tooling accuracy, performance and maintenance. “The only difference between a medicine and a poison is dosage,” notes Andy Dumelow, I Holland’s technical sales manager.
To aid its clients in meeting the stringent needs of regulators around process traceability, I Holland wanted to develop a comprehensive software system that would encompass its proven seven-step maintenance regime. “Although we had a measuring system, for monitoring the wear and tear of our tooling, it didn’t manage the day-to-day maintenance,” Mr Dumelow explains. Having a comprehensive automated system for tracking, managing and reporting everything (from when punches were manufactured, to when they are cleaned and measured) would allow pharmaceutical companies to satisfy the level of vigilance and risk mitigation required by the authorities.
After assessing quotes from four potential software developers, I Holland chose One Beyond to design the critical new system. “They stood out because of their experience and understanding of the regulations we needed to meet. I was also very impressed by the type and quality of work they had undertaken for other companies, and by their flexibility and ability to support and guide me through this project as an engineer who doesn’t have a background in software,” Mr Dumelow says.
They stood out because of their experience and understanding of the regulations we needed to meet.
One Beyond worked with I Holland to determine its exact needs, and built a comprehensive, affordable tooling lifecycle and rotation management from scratch. This will enable I Holland’s clients to proactively monitor and report on tool rotations, tooling inventory and tooling maintenance. It can also be used to archive tool images and drawings, and even keep a record of tablet quantities by number of tablets, work order or batch information – allowing everything to be stored in one place for easy access and assessment.
One Beyond created the bespoke, self-contained system using the latest popular Microsoft technologies, and built an RS232 USB interface to connect it to the hardware for direct monitoring. The system is compliant with the 21 CFR Part 11 FDA standard for record-keeping, required for medical systems. Users can define the types of reports they produce for maximum flexibility.
Importantly, the IH-TMS is easy to use, with a simple touchscreen interface that will alert users if there is over compression, or if tooling replacements or scheduled maintenance are required.
“The system’s ease of use is crucial, because very often the users won’t be engineers or scientists,” Mr Dumelow notes. Another valuable feature of the system is its advanced language capabilities – it is capable of supporting almost all languages around the world, including Arabic and Chinese. “This is important for giving auditors information in their local language and is a big plus of the system.”
The new system, which is about to be rolled out with clients, has gone down extremely well with I Holland and its customers. “We’re delighted,” Mr Dumelow says.
“I’m impressed with everything about it. It’s a very, very good piece of software which absolutely meets our requirements, and gives us even more than we expected. We believe it will give us an edge in the market and allow us to win new business.
“We shared the system with 21 different market representatives at a recent seminar for our overseas agents, and the feedback was excellent,” he adds. “The system is already being translated into four other languages, and we envisage we will support 14-16 eventually – including Russian and Chinese.
“The One Beyond team held our hands throughout, which was exactly what we needed,” Mr Dumelow concludes. “We’d definitely recommend their work; they’ve been a superb development partner.”
We’d definitely recommend their work; they’ve been a superb development partner