Introduction

The implementation of "Real time Testing (RTT)" or "Real time Release Testing (RTRT)" in pharmaceutical production has become a goal pursued by more and more pharmaceutical factories, as it can improve testing efficiency and ensure the quality of production materials (such as pharmaceutical water). A successful RTT plan must fully consider what methods should be adopted to achieve data reliability, data transmission, and data security, which is crucial. Incorporating the above considerations into RTT strategies and implementation plans can enable pharmaceutical factories to better meet current regulatory requirements for data reliability and maximize the effectiveness of RTT plans.

21 CFR Part 11 (Chapter 11 of the Federal Regulations) and the transmission and reliability of data under the guidance of 21 CFR Part 11 and the principles of data transmission and reliability under the guidance of the US Food and Drug Administration (FDA) have always been industry standard requirements. 21 CFR Part 11 was released in 1997 to address the need to maintain data security through electronic data transmission in the digital age. 21 CFR Part 11 requires pharmaceutical manufacturers to control and comply with regulatory requirements in the following areas:

• Data security

• Data retrieval

• Verification

• Audit trail

• Operations, permissions, and device control

• Electronic signature

In the digital age, with the popularization of electronic records, 21 CFR Part 11 and ALCOA+provide guidelines for maintaining the reliability of data. According to the "Data Integrity and Compliance with cGMP Guidance for Industry" document released by the FDA, data reliability refers to the completeness, consistency, and accuracy of data.

Software Solution - DataShare Elite

After transitioning to real-time detection, the source of data changes from the quality inspection laboratory to the actual production environment, so it is necessary to use software to centrally manage this data. DataShare Elite is a Sievers software solution designed to automatically transmit and retrieve data related to quality attributes. The DataShare Elite software provides a single central location to manage all Sievers TOC and conductivity data, which comes from multiple instruments installed at various production sites. This enables the quality inspection department to easily access real-time data from various production environments and remotely sign off on the testing compliance of raw materials (pharmaceutical water) entering the production process.

More content can be found in the attached materials!!