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Ensuring Data Integrity Compliance in Pharma With CDS Software

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Data integrity is fundamental to drug development and manufacturing, helping provide confidence in the data collected to ensure the efficacy, quality and safety of pharmaceutical products for patients. Data integrity is also crucial to secure trust between the industry, regulators and patients.

Yet achieving data integrity can be difficult for drug developers and manufacturers who have to navigate the complexities surrounding the strict data integrity guidelines provided by regulatory authorities and find effective ways to attain compliance. To address this, companies can employ chromatography data systems (CDS), which make achieving data integrity easier through built-in compliance features such as comprehensive audit trails, meaningful audit trail reviews and versioning for understanding changes to the data. In this article, we discuss the challenges that data integrity poses for drug development and manufacturing companies and explore how innovative CDS solutions can be used to overcome them.

Data integrity challenges in drug development and manufacturing

Drug development and manufacturing generates large amounts of data, which has further increased in volume and complexity with the rise of biologics. This data must be transparent, accurate and traceable as it will be the basis for making GMP decisions regarding the pharmaceutical product.

The intricacy of this data makes maintaining audit trails all the more challenging. Audit trails are hard to create given the large and complex array of data, but they are an important regulatory requirement and a proven, effective means of detecting data integrity issues.

Additionally, regulatory bodies require periodic reviews of audit trails. If systems do not capture enough information regarding the action performed or have insufficient sorting, filtering and grouping capabilities, reviewers may need to resort to manual steps to conduct a comprehensive and meaningful review, which becomes time-consuming and inefficient.

Moreover, data integrity regulations continue to evolve, with authorities releasing stricter guidance. The World Health Organization, for instance, is drafting new data integrity guidelines expected to take effect in 2020, outlining recommendations for complying with data integrity and ALCOA+ principles. These principles require data to be:
  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
  • Consistent
  • Enduring
  • Available

Drug development and manufacturing companies must ensure their data and workflows adhere to these principles and guidelines to avoid regulatory citations for data integrity issues.

Data integrity challenges in drug development and manufacturing

Data management systems, such as CDS software, make it easier for drug developers and manufacturers to achieve data integrity. Through CDS solutions, organizations gain the following benefits:

Compliance with data integrity guidelines: CDS software has the necessary technical controls in place to help pharmaceutical companies meet regulatory requirements. With compliance already built in, companies can progress projects faster and further speed up the drug development process, helping ensure the rapid delivery of therapeutics to patients in critical need.

Additionally, CDS software developers and suppliers have the necessary knowledge and expertise to meet regulatory requirements, carefully considering compliance when creating their data systems. They are committed to staying up-to-date on regulations, often being ahead of them by anticipating, designing and developing features that aid customers in meeting the latest regulatory thinking. With the confidence of knowing that the software adheres to the latest guidelines, scientists no longer need to keep track of all the regulatory details, allowing them to focus on improving the safety and quality of the drugs they’re producing.

Complete coverage of all actions:
CDS software provides audit trails documenting the history of all actions, with critical elements automatically and securely recorded by the system. The software also captures the cause behind users’ actions by providing the capability to define a list of common reasons for routine actions and corrections, or by allowing custom entries when none of those reasons apply. This automates the creation of audit trails, ensuring traceability and transparency of data and adherence to ALCOA+ principles.

Meaningful audit trail reviews: To assist in the review process, CDS software enables the segregation of audit trails according to their source — with separate audit trails for data, injections, instruments and instrument configuration — giving them context and making it easier for users to interpret them. Reviewers can query data and create reports based on the search results, using the available filters, groupings and sorting for a more comprehensive and tailored review.

All these features lead to a simpler and less onerous audit trail review process. Instead of spending time and effort preparing for these reviews, scientists and analysts can focus on the science, thereby improving productivity.

Data history: CDS software allows versioning of data items by assigning a unique version number to the sequence, injection, processing method, instrument method or modified chromatogram when a change is saved. Reviewers can compare two versions of a data item to view the differences between each and see where modifications have been made. They can then verify the effects and implications of these changes, determining whether they were justified and in accordance with established procedures.

Maintaining the accuracy of data helps build trust between the pharmaceutical company and the regulatory body. And most importantly, accurate data serves as the foundation for safe and effective drug development.


Ensuring a pharmaceutical product is safe for use means adhering to regulations and preserving the integrity of data across all stages of the drug development and manufacturing processes. Companies can achieve this with the help of CDS software, which provides data accuracy, extensive audit trails, meaningful audit trail reviews and compliance with regulatory requirements. With these benefits in place, drug developers and manufacturers can shift their focus to further improving the efficacy and quality of therapeutics and ensure their safe and swift delivery to patients.

About the author: Patrick Kenny is a product marketing specialist, chromatography
software, Thermo Fisher Scientific