Additional information
Source: Web-site of vendorThe project has been delivered on schedule
The budget has not been exceeded
Functionality complies with task
The project has been delivered on schedule
The budget has not been exceeded
Functionality complies with task
Low-Cost Expansion
“Bachem picked Ignition because it’s easy to expand. It includes all the features Bachem wanted in a single software package. If you pick any other software, they all have something missing. For example, some of them are missing alarm notification, and you’d have to go with a third party. But Ignition has all the features that you want for pharmaceutical projects, and for meeting the FDA standards.”
Fred Zaboli, senior control systems engineer at WME
Tim Tran, site manager for Bachem in Vista, said Ignition was the clear choice.
“We picked Ignition because it can be described in one word: simplicity,” he said. “It eliminated a lot of the complexity that we saw in other systems that we reviewed.”
“We were looking for a software package that’s easy to operate, and also easy to roll out to the whole site in the future and be compatible with all the existing systems. With Ignition, we are able to have that. And we especially like the compliance to CFR Part 11.”
Rudi Kuehnel, process engineer for Bachem
With Ignition’s unique licensing model — no extra fees for more tags, clients, users, or projects — Bachem can achieve its goals for less money than it would have to pay with other vendors.
“Compared to other software packages, Ignition was very cost-efficient for this project. As a project manager, I was very impressed with the capability of Ignition in terms of validation and startup and factory acceptance testing. We were pretty much able to run a simulation on the first day that the programming was done. The simulation helped us to eliminate errors before starting it up in the manufacturing unit.”
Fred Zaboli, senior control systems engineer at WME
Bright Future
Bachem also needed easy access to an audit trail, both for internal use and outside auditors.
“Audit trails are very important in the pharmaceutical industry. With Ignition, it’s easy to activate. On other platforms, you have to do a lot of engineering and programming ahead of time.”
Fred Zaboli, senior control systems engineer at WME
Bachem has also seen benefits from improved reporting.
“The reports and data from Ignition are very simple to retrieve and comprehend,” said Tran. “Overall, the experience with Ignition has been great.”
Easy integration with Microsoft Active Directory was another plus.
“The Ignition system uses Active Directory for its authentication, which is part of 21 CFR 11. With other software, they use generic accounts and passwords, which is not part of 21 CFR 11.”
Anthony Chong, senior systems engineer for Bachem
Bachem has been very pleased with Ignition’s performance, and is planning to expand its use.
“We plan to roll this out to the rest of the Vista site, which will be a ten-times expansion. We are looking forward to expanding the system, and we already have some projects in mind. For example, using some utility functions and integrating them into our process, to give operators more control over what’s happening outside of their process room. We see a lot of opportunity at Bachem with Ignition. It’s a platform that makes it possible to do almost anything.”
Reduce Costs
Ensure Security and Business Continuity
Ensure Compliance
No centralized control over IT systems
No monitoring of corporate IT processes
Decentralization of management
Decentralized IT systems