How 21 CFR Part 11 ensure data integrity in order to ensure product quality?

Data Integrity is one of today’s hot topics in the Life Sciences industry. The U.S. FDA and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) expect that data should be reliable and accurate. By definition, Data Integrity is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. This does not sound complex, but requires discipline and properly written and executed standard operating procedures (SOPs), something which should be customary within the highly regulated Life Sciences industry. Data Integrity applies to both paper-based and electronic quality management systems in laboratories, production, logistics, etc. Here comes the role of 21 CFR Part 11, which automate the whole process and establish data authenticity.

Maintaining a purely paper-based system may be a good option for small organizations. They can certainly maintain good data integrity combined with well-trained personnel and up-to-date SOPs. But consistency could still be problematic.

The majority of organizations in the Life Science industry use both paper- and electronic-based processes. In order to make sure data integrity can be applied to the utmost extent, these organizations should ask themselves:,

• Would it be better to eliminate disparate solutions and replace them with a harmonized system?
• Would it be better to select a system that provides the greatest possibilities of closed-loop processes to avoid redundancies and paper outside the solution?
• Would it be better to have a system that complies with the regulations, such as full audit trails, electronic signatures (21 CFR Part 11)?
• Would it be better to have a system that provides modern integration capabilities to ensure data integrity across different systems?
• Would it be better to have a system that provides multi-language capabilities to support local users and avoid data integrity issues caused by language issues?

QEdge –Quality management system 21 CFR Part 11-compliant allows you to gain better control and visibility of your quality processes, boosts your confidence in your product quality, and prepares you for successful regulatory audits.