But going from a paper-based business to a cyber-based one is not easy or quick. It will take time, and it will require both diligence and patience. Luckily, there are many software programs out there to make the transition as easy as possible. The process entails three key steps:
- Going digital and remaining compliant
- Going automated and remaining compliant
- Going global and remaining compliant
Going Digital
Most modern corporations have a plethora of computers holding all the company vitals. The problem? It should all be in one place, not scattered throughout 12 different hard drives. So, the first step is to electronically capture all the information you can, which includes any models, drawings, tooling designs, and schematics. The good news is that most companies have already accomplished this part. What is left on the task list is the installation of a product data management capability which performs the very significant task of tracing every stage of development.
This is where many companies may fail to comply with federal regulations. A product life-cycle management (PLM) system should be able to pull up any and every stage of the product design and production. All of this data is necessary to construct what is known as a design history file (DHF). The DHF is a favorite of FDA auditors — indeed, few successful FDA audits are conducted without one.
Step Two: Going Automated
Many professionals might think that going digital and going automated are one and the same. Not quite. Digital simply implies what type of media (paper vs. chip) a company uses to store information. Automated has to do with the readiness with which one is able to retrieve that information. Product data should be able to be automatically tracked, reported, and collected. Documenting every change a product undergoes while in development can be painfully tedious, but it is not particularly difficult, and again, auditors love to see this kind of thing during an audit. So it is a must in any software you choose to implement.
Step Three: Going Global
Some companies will resist this step because going global does entail quite a bit of risk to company security, project management, and intellectual property protection. But for those who wish to really compete beyond the local market and have their products manufactured for a much lower cost, going global is perhaps the most significant of the three steps for both commercial and audit success.
Any suppliers or manufacturers you are connected with around the world through software applications are probably connected to you via the Internet. The PLM system you implement should therefore be a web-based system built on standard web protocol. The IT plan you utilize will determine how employees access company information and will help you complete and maintain compliance during any potential audit.
