It’s 2015 and as an industry we’re still struggling with the elimination of manual processes. The attitude in the pharmaceutical industry has always been one of closed systems, with corporate headquarters having access but affiliates and external partners not being allowed into the system.
As a result, affiliates and partners were forced to send information by manual means; an email with a document or information, a fax, a mailed hard copy. Someone at the corporate headquarters had to enter that information manually and then confirm with the owner of the data if the information is right or wrong. That’s a cumbersome process. It’s a challenge most companies are struggling with, and why most are eager for the right solution to allow them to gather information from multiple different users around the world in one centrally accessible system. And it’s a challenge that the business has had to deal with.
Past Problems Continue
Years ago while I was working in the pharma industry, the company had just implemented a policy requiring manufacturing sites to let regulatory know the first time they used a label in production, because we had to report first use. At the time – and this was before the advent of email – they would fax that information, and all too often that information was wrong or inconsistent. There would be a lot of back and forth querying the information, which in itself presented a challenge because of language barriers. If we had had a system where they could just enter the information directly and ensure its accuracy, it would have simplified the process.
Even now, though, with technology solutions in place to enable information to be shared, users will take documents out of the controlled environment, email them to multiple people, and get everyone’s responses in separate emails – leading to multiple different versions of the document. This then requires the document owner to have to consolidate into one cohesive document.
Many companies have incorporated paper-based business processes into their technology, rather than streamlining the process to use the technology. This results in the continuum of manual and time-consuming processes.
I’ve been on the receiving end of exactly this type of problem. Another company that I worked at had just implemented FirstDoc. This was a global system incorporating the whole concept of simultaneous review and approval within the FirstDoc system. It was awesome. But the person responsible for updating the standard operating procedures (SOPs) insisted that everyone print out the document, write out their comments, come to a global video conference and go from person to person in a “round robin” to discuss their comments. It totally undermined the value of the electronic system that was meant to simplify and vastly improve a paper-based process.
It’s About Process and Corporate Commitment
The reality is that those responsible for purchasing the solution very often do not realize the impact to the business processes. There is a corporate investment needed to redefine the business processes in a way that utilizes the electronic system to provide efficiencies over the paper processes. The thinking often has been to simply leave it to the users and they would figure it out. But as we know, that doesn’t happen, because busy people simply don’t have time to try to improve processes, even if in the long run it will save them time. That has led to user frustration with technology not truly meeting their needs.
We’re starting to see a change in thinking. Rather than simply acquire a system, put it in place and leave users to work it out, company leaders are now looking to the vendors to support them in redefining their processes for the new way of working.
Another big change is that users are saying enough is enough: The time involved in continuing the manual processes of managing data, never mind the errors this creates, is impacting how they work.
Thirdly, the advent of the cloud and new user interfaces has made it a lot easier to provide more open global access to affiliates and partners. At the same time, companies have realized they have to be more lenient about letting “outsiders” into their system. They used to have rules in place that allowed no external people (affiliates included) behind the firewall. Now as long as it’s secure, they’re happy to be more flexible, and the technology available today can provide that access.
In fact, my experience is that when we do implementations and customizations and even internal security models, companies are coming to us and saying they want a more open, flexible system to allow those that need access – internal and external – to get access in a more streamlined, less IT-controlled fashion.
These developments leave me optimistic that the age of manual processes is finally drawing to a close, meaning users can get on with doing their job efficiently and companies can be assured that the data in their systems is controlled and they can rely on the accuracy to make informed decisions.
Visit us at DIA eRegulatory and Intelligence Annual Conference, May 11-13 in Philadelphia. We are looking forward to meeting you at booth #500, and show you how to embrace capital-efficient innovation for RIM.