How to Make FDA Audits Easy
FDA audits are a burden and not being prepared can be a challenge. This article provides a solution to help simplify the FDA auditing process.
Understanding the Regulations
Besides reading the regulations, which can be time consuming, manufacturers can take an online training course. They don't need to worry about knowing the nitty gritty details, but rather an overview to know exactly what they are required to do for their entire manufacturing process and mainly the quality control process. These training courses are readily available and take a few hours to complete over several days.
The running joke for GMP is that it stands for “get more people, get more paper.” The best way to make FDA audits easy is to digitalize your processes and track everything. It's much easier to track down a document in a cloud based software, rather than to track down a paper-based document in a filing cabinet that may not even be stored onsite.
For example, if a large company is still using paper, and needs a record from five years ago. That record is shipped off site and stored in some bins. They then have to call a third party company to track down and mail the container to them so that they can hopefully find the correct documentation in that box. If it’s unfortunate enough to have been filed improperly, then they have to go on a wild goose to hunt and track down other boxes to find this documentation. To remedy this issue, they need to digitalize their processes.
Immutable Ledger Technology
Digitalizing their documents and tracking their processes online is the main solution. However, using an immutable ledger system, such as blockchain, to store their data is the best option. It is completely secure and can't be hacked. Additionally, the data, once entered cannot be altered, only amended. If something wasn't documented then it doesn’t exist in the system, so there's no possibility of fraud.
Keeping SOPs On Hand
The fourth point for making FDA audits easy is keeping SOPs on hand. Standard operating procedures are required by regulation. Companies need to have a detailed standard operating procedure on every step to follow for a certain process. SOPs are required for processes such as pest management and sanitation, down to how they're encapsulating the dietary supplements. Having SOPs handy and ensuring people are following them correctly is ideal. The FDA will come in and audit these companies, pull up the SOP and ask personnel where the SOP is and ensure that they're actually following it correctly. With digitalization, if a company has the SOPs on hand in real time, and they do not have to refer to a paper binder; they're now easily accessible. Digitalization is the best way to store and instantly access SOPs, and easily pass those routine FDA audits.
OmniBlocks Helps to Digitalize and Track Processes
RB Technologies’ OmniBlocks software helps companies to digitalize their manufacturing processes and track the entire workflow. It also keeps the SOPs on hand. OmniBlocks is completely designed around GMP regulations that companies have to follow. By having an overview of the regulation from a training course and using OmniBlocks, companies are completely set to easily follow, or easily pass these FDA audits. Additionally, OmniBlocks uses the blockchain network in the background, so you can be assured that everything is documented properly and there will be no data loss. Additionally, there is no chance of fraud which makes FDA audits easier. Those regulatory agencies are going to trust you more because of this system.
For more information on how to future proof your business, visit our Website: https://rbtinc.io - discover how to move forward with adopting a digital solution at your manufacturing facility and improve your supply chain to make FDA audits point and click simple.
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