Increased scrutiny on data integrity forces pharmaceuticals to reconsider validation techniques
As regulatory authorities impose stricter notices on self-examination, pharmaceuticals need to find better ways of ensuring the accuracy of their data integrity
Data integrity is a fundamental component of quality pharmaceutical systems, because it ensures that medicines are safe and effective for public use. In the past, data integrity was relatively easy to prove by using forensic methods and analyzing ink and paper, but the advent of computerized systems has brought a different layer of complexity to the process.
Identifying whether undocumented or even malicious changes to electronic data or records have been made requires additional tools and specialist expertise, which is probably why data integrity has fallen under increasing scrutiny from regulatory authorities.
This became apparent in July of this year, when the State Food and Drug Administration of the PRC issued a notice for the self-examination and review of clinical trial data for drugs. The notice significantly impacts pharmaceuticals, as these now need to find the additional resources, tools and expertise to further self-examine their data in order to guarantee drug safety and compliance.
Increased complexity of data integrity verification
Data integrity requires data management throughout the entire life cycle of the data, and covers a large range of areas, including internal environment, quality systems, and management culture. As a process, data integrity verifies that data has remained unaltered in transit from creation to reception.
Data undergoes any number of operations, such as capture, storage, retrieval, update and transfer. It is therefore critical that pharmaceuticals apply an effective and comprehensive process to ensure data is kept free from corruption, modification or unauthorized disclosure.
One-stop shop tools can ease pressure on workload and resources
Database security professionals can only employ a limited number of practices to ensure data integrity, a task that has now become increasingly time and resource heavy. Many pharmaceuticals are therefore turning towards data integrity tools to support their self-examination process.
NNIT has launched a powerful data management platform that provides a one-stop-shop solution for clinical trial data integrity. The solution, which can be fully customized and integrated with individual data needs, provides fast, accurate tracing, scanning and timely reporting, thus minimizing the self-examination workload and increasing work efficiency.
The service includes data sorting that covers the entire lifecycle of the data and reusable templates and evaluation forms, and can also provide support for bio specimen analysis and testing instruments. NNIT uses proven processes and templates to ensure efficient and smooth compliance verification and is able to lean on extensive experience of serving multiple pharmaceutical enterprises both at home and abroad.
Independence with a helping hand
While customized data integrity tools can add much needed support for the data verification process, in order to really improve self-examination skills, internal staff also need to understand the company’s data management requirements and self-examination techniques.
Most companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical equipment, and information about training of their laboratory staff as justification for the validity of the analytical results.
However, the new regulations on data integrity have now rendered this type of validation insufficient. Having a team of data integrity specialists provide a more consultative approach to self-examination can provide invaluable support here.
NNIT offers a complete continual consultative service that includes internal audit assistance and personnel training, regular audit report issuance and customized reports for self-examination activities. Becoming efficient at self-examination has become essential for pharmaceuticals to survive compliance, and the specialist expertise required to achieve success in this area continues to grow in complexity.