The harsh reality for every Life Sciences company - companies that manufacture drugs, medical devices, or other products with the potential of causing physical harm to humans - is that they must operate in control and according to numerous compliance regulations, including FDA 21 CFR Part 11
. But within this constant, every company makes decisions about how to build their processes (tasks and resources applied to activities to produce an outcome) and what strategies to operate with in relationship to these regulations.
The idea we discuss with Life Sciences companies today is growing with muscle, not fat. Specifically, we help companies understand that the many compliance processes that they currently perform with manual methods are very costly relative to growth.
The biggest cost of manual processes is – yes – people. When you grow, you have increased volumes going through your business processes, and variations in those processes based on different types of customers, orders, products, suppliers, etc. Many times it is not a linear relationship, but exponential in terms of the people you have to add relative to the business growth. Sometimes, it cannot be covered just by adding people.
However, the more important costs of manual processes are time and visibility. Manual processes store data in a disconnected and difficult-to-access manner. If data related to these manual processes is required for decision making, there is often a time delay in getting the data into a consistent, usable format. And because it is costly to gather the data, many companies decide to operate without it, which leads to decisions that are less optimal and often time delayed. Of course, on top of all this is the issue of errors related to gathering and entering the data in to a usable format.
The bottom line is that manual processes add stress, costs, and risk to an organization, and is one of the main drivers for looking at automated compliance approaches.
Automated compliance is what the market rewards. Ultimately, the supply chain that you are in or will be in will quickly learn of the companies that are able to produce efficiently and with high control and compliance. Many companies that we speak with come to us because they have been given a choice to make about this. Buyers are now demanding that suppliers have an automated approach to compliance because the buyer understands what it means to them.
Traditionally, we talk to a lot of companies that think about efficient business processes and compliance processes as operating in an inverse direction. In other words, if you increase your level of regulatory compliance, you will reduce the efficiency of your business processes, and vice versa. We have found, however, that there are huge gains to approaching both within the same automated manner; thereby increasing the efficiency and flexibility of their business processes at the same time.
Companies can get the best of both worlds - that is, more efficient processes with automated compliance controls - by moving to a unified central business system that has enterprise compliance capabilities built-in already. These systems can help Life Sciences companies:
- Eliminate manual efforts and paperwork, reducing errors and saving time and human tasks
- Audit, capture and store information according to 21 CFR Part 11
- Automatically enforce controls according to SOPs
- Cost effectively and rapidly deploy business systems in a validated manner
- Enforce controls, but with the flexibility to adapt and grow with your changing business over time
At Merit Solutions
, we have taken this philosophy and built the model of our company around it. This model includes service methods, pre-built intellectual property, and software components that are built within the Microsoft Dynamics ERP software – all to help Life Sciences companies realize the benefits of reduced risk, increased operational efficiency, and the continued building of a foundation on which to grow.