Data is the lifeblood of your business. Without it, it can’t function properly, and your company will suffer as a result. You need to protect that data at all costs, but how do you do that?
RC REDOL is a company who guides other companies in implementing data integrity management strategies for good manufacturing practices. The main purpose of this process is to make sure your company doesn’t fall victim to malicious activity that could put your sensitive information at risk.
Several guidelines have been published during the last year and data integrity is a high focus of governments around the world. As a result, warning letters from FDA or EU involving data integrity have increased significantly over the last year. These have included falsification of data, cases of documentation not being done contemporaneously, uncontrolled use of forms, data being changed, deleted, excluded or destroyed. Also, selective reporting of results, unauthorized changes of raw data and changes to raw data or documents haven´t been documented.
The goal of a data integrity management strategy is to ensure the safety of your information, while also protecting against financial loss, due to fraud or theft by individuals with authorized access privileges. Vulnerabilities are identified in existing systems, implementing security measures like access controls, and testing those measures for effectiveness before they go live.
The assessment shows you how to best respond, so you limit damage done by an unwanted exposure of your information. This is accomplished by strong security protocols, as data can come from many different sources, which is why it is important that the person who generated the data can be identified. If this information isn’t available, then there are problems with data quality, analysis, or validation. The best way to ensure that all the necessary information is recorded is by either generating a paper record or by an audit trail.
To help minimize risk and protect their business, many companies need proper data management policies put in place, so they can better monitor access privileges and limit who has access to sensitive information. By implementing these steps into their company’s practices, it will be easier for them to identify any potential risks that may arise with the protection of their critical assets and information.
Essentially, if you want to be at ease regarding data integrity, when you start your business, a data integrity culture must already be present. This is the way your operations will be safe, efficient and your results in regulatory inspections and audits will excel.
If you have any doubts, or you are in need of help, you should contact an experienced company, like RC REDOL, who has a data integrity specialist on its team, Engineer Ana Gonçalves.