Data Management and the Data Integrity Breakdown in the Life Sciences
The backbone of Data Management is data integrity. Storing and protecting data is important to most companies. But, in the dynamic world of the Life Sciences industry, it is crucial. Regulations are changing constantly, as are the breadth and types of data being collected. Combine all of these factors and you see why keeping your data protected and stored correctly is paramount. According to guidelines published by various regulatory bodies, the definition of data integrity is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. The requirements for data include that they are attributable, legible, contemporaneous, original, and accurate (ALCOA). Implicit in the requirements for ALCOA are that data should be complete, consistent, enduring, and available (usually referred to as ALCOA+). (To read the FDA’s Data Integrity and Compliance With Drug CGMP, click here)
However, the tools used by many emerging life science companies around data integrity can be highly limited.
In a study performed by GatePoint Research, it was found that an overwhelming majority of life science companies are not using industry-focused tools to manage their data. About 70% of respondents stated that they used some aspect of the Microsoft Office Suite to manage their data. That includes applications such as Azure, Office 365, and Sharepoint. These tools are not inherently designed to meet US and international guidelines, so they require a significant amount of effort to create manual processes within them. In the study, roughly 46% of respondents stated they use email to manage data within their team. This method leaves companies vulnerable when it comes to audits and data security.
In a study by Deloitte, “When implementing a programme to identify, develop, review and improve data integrity across an organization, a focus on standardization and procedures, risk assessment, technology and systems, and data governance will be essential.”
A ready-to-use QMS for life science shifts the focus.
Using a QMS document management solution specifically designed to handle the life science industry can make a huge difference in the effectiveness of data management. It does this in specific ways:
- Accessibility – Regulating who has access to what document is an essential tenet of document control. Role based access and user permissions not only help ensure more efficient document management, it also is key to defending against malicious hacks Using legacy systems, or tools designed for generic business use, can leave your information vulnerable to access violations that will surface during a potential audit.
- Integrity – Life Science companies are now routinely handling large amounts of heterogeneous data that is now in a digital format. Storing it in a location that is uniquely built to protect data is essential. But encryption processes are not simply needed when the data is at rest. A cloud-based QMS protects it when it is in use, while also creating a digital trail of where the data has gone, who has touched it, and how it has interacted with other data sets. All of this happens throughout the data life cycle.
- Organization – Depending upon your Life Science industry, the way in which you organize your data will be different. The needs of someone needing to store Gene Ontology data versus someone storing control specifications for a new medical device can be wildly different. These varying needs are easily handled by a ready-to-use QMS.
- Searchability – While having data stored securely and efficiently is important, it is not useful if, like paper-based or legacy solutions, the data is not easily accessed or searchable. When storing your data in a QMS built for Life Sciences, the data is accessible to anyone with the right credentials to search for and easily find it.
As we dive deeper and deeper into Data Management, the concept of data integrity will be less a general concern and more a foundational principle of the QMS system.
The integrity of your data should be independent of government regulations and from the people who have access to it. Unlike legacy systems, and definitely unlike paper-based systems, data integrity in a cloud-based QMS built for Life Sciences is automatic and integral to all the other aspects of quality management.
If you want to learn more about how a Ready-To-Use QMS can dramatically shape and improve the speed of your business, download our most recent eBook, The Need for Speed. It takes a deeper dive into how a Ready-To-Use QMS differs from a standard legacy or paper-based solution.