Data integrity inefficiencies do exist in the pharmaceutical industry, which is why students in quality assurance training must remain especially diligent. When it comes to supporting data integrity, many processes and technological updates are involved to ensure the safety of all information. Product quality and public safety are top priorities, which is why all involved parties must take this topic seriously.
The importance of record keeping in the pharmaceutical industry was established in the early phases of pharma production but has remained at the forefront of quality assurance efforts as processes become increasingly digitized. Digitization has improved a number of aspects of documentation but has presented some challenges as well. Continue reading to learn three tips for supporting data integrity with quality assurance training from the NeuAge Institute!
1. Avoid the Most Common FDA-Cited Errors
The FDA and other regulatory agencies send out warning letters and citations when breaches in data integrity management are found. When you complete your pharmaceutical quality assurance program, you’ll want to be familiar with the most common mistakes to ensure you can avoid them.
Errors to be on the lookout for include deletion or manipulation of data, abortion of analyses without approval, destruction or loss of data, lack of documentation contemporaneously, and overall uncontrolled documentation. Some of these mistakes are able to be fully controlled by your actions and decisions on the job, so always be sure to follow each and every data entry, documentation, and analysis protocol that your facility requires. This is the best way to ensure the accuracy of the study, the safety of patient information, the quality of the product, and the integrity of the company.
2. Streamline Compliance Efforts with Quality Assurance Training
Once you have completed your quality assurance training, you’ll have an understanding of the major risks to data integrity as well as the best strategies to manage data responsibly. One best practice that you can ensure is acted upon in your workplace is the use of a single platform to help streamline compliance efforts. When all data is handled in one system, then the possibility for error diminishes with fewer instances where data integrity could fall short. You can even advocate for all areas of research and development, quality control, and quality assurance to become well versed in the same platform; that way, all team members understand the processes well and can operate within the same digital workspace. This helps streamline important steps of data processing, including tracking, documentation, retention of data, and more, and helps avoid those unwanted warning letters from the FDA.
3. Avoid Getting Complacent
The key to data integrity is diligence, but this step can’t be completed in one day. Diligence must always be maintained with such precious data in your hands. Data integrity is an ongoing process, and becoming aware of the implications that mishandling of data can have will bring you one step closer to being confident and in control of your ability to protect these data. One way to stay diligent is to update your knowledge to ensure you understand recent alterations in standards, data guides, processes, and regulations that affect data integrity. Keeping up with the latest requirements will help with overall compliance and ensure you are successful in your role in quality assurance.
Interested in learning more about quality assurance in the pharmaceutical industry?
Contact the NeuAge Institute for more information!
