Four years seems like a long time in many respects. In November 2013, the U.S. Congress gave the pharmaceutical industry four years to figure out how to put a unique identifier (serial number) on every one of the Rx units-of-sale in the United States. On the face of it, it does not sound so difficult and is a respectable amount of time.
Then you look at the details of the law, research what is possible, put together a budget, build a schedule, define the resource and personnel requirements, and so on. Now, it is almost impossible to imagine… except everyone has to do it.
So let’s assume you have done your research, put together your budget and built your schedule. Let’s also assume you have placed orders with equipment vendors and they are diligently cutting metal, fishing wire and writing code for your new and retrofit equipment. And let’s also assume you have selected an enterprise-level serialization solution vendor. You are not in bad shape at all.
Now, let’s reassess your resource and personnel requirements vs your time table. Do you have enough people to FAT and commission these machines? Are you confident your IT department can interface with your serialization solution vendor? Do you know all of the procedures affected by this new system and are you ready to rewrite all those procedures? Are there enough resources to train all of the employees who are affected by the new procedures?
You might say ‘yes’ to these questions. And if that is the case, good for you! You’ve put in the time and thought, and the reward is coming in a few months when you are online and operational.
If you said no or you are not sure, it might be time to look outside your organization. Most companies do not have an excess workforce set aside for huge projects like serialization implementation. Your staff already has full-time jobs. Sure, you may have engineering and validation personnel that perform some of these tasks all the time, but the 3-5 new or retrofitted machines and systems per packaging line affected by serialization adds a large burden to the technical pool. Plus, additional personnel are needed to determine, write and review the procedure changes, and then train the operations staff on those procedures.
If there were ever a project that was designed for outside help, implementing serialization is near the top of the list. Contract help can assist you in evaluating your current process, map it to the new process, and implement the changes. Some of your contractors can be tasked with the dozens of time consuming activities that you do not need to be 100% involved with where the results are all you need to see (i.e. process flow diagrams, SOP development, vendor management, parts of your FAT and commissioning execution, project schedule maintenance, etc.).
By teaming with an outside contractor, you can work hand in hand with them to achieve success. You will need to understand and agree with the new packaging procedures which need to be tailored to your business culture, data collection expectations, flexibility requirements, etc. This is where your full-time employees should be focusing their time because these are the pieces only they know. Good contract help will allow your full-time employees to focus on the important details and a successful implementation of serialization without getting bogged down in the minutia.
(Source: IPS – Integrated Project Services, LLC)