The data you collect is the lifeblood of your business. Without it, you can’t operate efficiently and your company will suffer as a result. You need to protect that data at all costs, but how do you do it?
RC REDOL is a company that guides other companies in implementing management strategies for the data integrity required for Good Manufacturing Practices. The main aim of this process is to ensure that your company is not affected by malicious activities that could put your sensitive information at risk.
Several guidelines have been published over the years and data integrity is a focus of regulatory bodies around the world. As a result, warning notifications from the FDA or the European Community 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, erased or destroyed data. Selective submission of results, unauthorised changes to raw data or undocumented changes to raw data are also part of these notifications.
The aim of a data integrity management strategy is to ensure the security and integrity of your information, protecting your company 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 these measures for efficiency before they go into production.
The assessment reveals how best to respond so that the damage caused is limited. This is achieved through strong security protocols, as the data can come from different sources, which makes 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. The best way to ensure that all the necessary information is recorded is to generate a paper or Audit Trail record.
In order to minimise risks and protect their business, many companies need 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.
Essentially, if you want to operate with peace of mind when it comes to data integrity when you set up your business, this culture must already be in place. Only then will you achieve more effective and secure operational results, as well as excellent results in audits and inspections by regulatory institutions.
If you have any doubts or need help, you should turn to an experienced company such as RC REDOL, which has data integrity specialists on its team who can help you analyse your company, establish an action plan and guide you in implementing a data integrity strategy.