As the term implies, Process Analytical Technology (PAT) relies, in part, on technology to help bring biopharmaceutical and device factories into the 21st century.
For many, this means working with your information technology (IT/ICT) department. In this article, I lay out several time-tested tactics and tips for working with your IT department to get what you need, especially when it comes to compliance and PAT.
A Cautionary Note
A recent Chief Information Officer (CIO) I worked with noted that, “PAT seems like CRM all over again.” For those who don’t remember, Customer Relationship Management (CRM) took the business world by storm in the 1990s, promising to dramatically increase sales, profits and so on. For some companies, CRM panned out (and even achieved close to the hype); for the vast majority of firms, however, CRM was simply another technological tool that has since required constant care and has not yet come close to achieving even the modest goals originally envisioned.
Therefore, when discussing PAT, keep the cautionary tale of CRM in mind. Technology tools, in and of themselves, will never catapult a company into world-class manufacturing and best of breed facilities.
Stage of IT
The first step is to determine how effectively the IT department is operating:
- is IT struggling with the day-to-day and barely keeping its head above water? or
- is IT making good progress on bigger picture projects and strategic objectives?
A number of fancy methodologies abound to determine this, but a quick way to get a handle on where your IT group falls in the continuum comes by asking one question: what is the ratio of IT staff to non-IT staff?
Ratios at 1:40 and above mean that IT is probably focused on the day-to-day and maintenance, with only minor progress on large-scale projects such as Part 11 compliance.
While not perfect, this should at least give you an idea if you can ask IT to play a strategic project role or will need to rely more on the PAT vendor(s) and have IT involved at a more tactical level.
Selection of Any Technology Tools
At some point in the project, the team will be ready to implement automation. IT needs to be brought in before any choices are made.
Ask IT department the following:
- What is the minimum level of network technology required for any automation to hook up to the factory network (listen for terms like “CAT6e” and “Ethernet” and “100Mbps”)? These items must go into any spec sheet to review potential vendor products.
- How does the IT department plan to integrate the system into the network? Would they like to do it themselves or have the vendor help? Rarely will an IT department choose to do it themselves, but I find that offering the choice shows confidence and trust in your IT colleagues as valued team members.
- What would IT like to see in terms of long-term maintenance contracts and quality agreements with various vendors?
- Are there any IT initiatives involving the factory infrastructure you (and the vendor) should be aware of? After you’ve bought the automation tool and signed the long-term vendor support contract is not the time to learn about the factory network upgrade project.
Automation Task Oversight
While you may not be able (or want) to ask IT to help manage the entire PAT project, consider at least having them help manage the portion of the project involving automation tools. The IT profession has spent decades working on various project management methodologies and often manage projects at a very mature level.
As part of this, note that IT also frequently has excellent reporting and benchmarking tools available. Consider leveraging these for at least the automation tasks of the project. As you implement and fine-tune the automation, use the project dashboards to see if they will work when reporting on the overall project.
Note that from a compliance standpoint, consider retaining IT’s various project reports as part of the overall documentation and to support eventual validation of the automated tools under current Good Manufacturing Practices (cGMPs).
Bring in IT Early
Make sure to ask IT to the table early on in any PAT activities; IT may need to schedule significantly in advance to best to help out. This is particularly the case if your firm outsources the IT department. Depending on the terms of the contract, find out if the IT outsourcing contract will cover this type of work in the factory, or if you need to carve out a separate statement of work.
Based on my career experiences as a CIO, IT groups always appreciate a friendly “heads up” followed by a bit more information on what might be required. Judge what you will say based on your estimate of what stage your IT department is in.
An IT department that is making good progress on strategic level projects plus supporting the day-to-day may want to kick-off a project; insist on IT being part of your project, not a separate, parallel project. Vice versa, an IT department struggling to keep its head above waters just in the day-to-day maintenance and installation may not want more than a “heads-up” and a “we’ll keep you cc’d on the meeting minutes, but for now, we’re still a long way away.” That type of reassurance will help you gain positive reactions.
Final Thoughts
Process Analytical Technology relies on automation technology and in-line sampling. This makes it necessary to work with your IT department to ensure you get the biggest bang for your buck when exploring various pieces of equipment and toolsets.
Remember, however, that PAT is not just technology; if anything, the “T” for technology is really just a third of the overall PAT framework. The bulk of PAT is analysis, risk management, science, statistics, and process management. The “T” in PAT is only technology tools that will help you do this work faster. It may be that the first step in planning for PAT is getting an independent assessment of your processes.
Are you ready?
Adapted from an article published in SmarterCompliance 2(7), July 2008