The data you collect is the lifeblood of your business. Without it, you cannot operate efficiently and your business will suffer as a result. You need to protect that data at all costs, but how do you do it? On October 12, the Technical Director of RC REDOL, Eng. Ana Gonçalves, will speak at SOPHIDIS DAYS on various topics and Data Integrity will be one of them.
In fact, this topic has had a lot of attention from the responsible authorities, as several guidelines have been published during the past year. As a result, FDA or European Community warning notifications involving Data Integrity have increased significantly over the years. These have included falsification of data, failure to record on time when completing documentation, as well as uncontrolled use of forms, altered, deleted, deleted or destroyed data. Also, part of these notifications are selective submission of results, unauthorised changes to raw data or undocumented changes to raw data.
The implementation of management strategies for data integrity is therefore necessary to good manufacturing practices. The main objective of this process is to ensure that your company is not affected by malicious activities that could put your sensitive information at risk. The goal of a data integrity management strategy is to ensure the security and integrity of your information, protecting your business from financial loss due to fraud or theft by individuals with authorised and privileged access.
Vulnerabilities are identified in existing systems, implementing security measures such as access control, well-defined procedures, training, as well as testing those measures for effectiveness before they go live. The assessment reveals how best to respond so that the damage caused is limited. This is achieved through strong security protocols, as data can come from different sources, making it essential that the person who generated the data is identified. If this information is not available, problems are created with data quality, analysis or validation, and the best way to ensure that all necessary information is recorded is to generate a paper or AuditTrail log.
In order to minimise risk and protect their business, many companies require data management policies so that they can monitor staff training, improve access privileges and limit who has access to sensitive information. By implementing these steps into company practices, it will be easier to identify potential risks that arise in protecting your critical assets and information. If you have questions, or need help, you should turn to a company with experience, such as RC REDOL, which has in its team a data integrity expert like Eng. Ana Gonçalves.