The importance of impeccable data: Why verification is non-negotiable in Regulatory Affairs

In the highly regulated pharmaceutical and biotech industries, where patient safety, product efficacy, and market access are paramount, data integrity is essential.

Regulatory professionals across Non-Clinical, Clinical, and Chemistry, Manufacturing, and Controls (CMC) functions bear the responsibility of ensuring that data submitted to health authorities is accurate, consistent, and aligned with original laboratory records.

The journey from raw experimental data in labware systems (such as Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELNs)) to comprehensive technical documentation in regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA), is intricate.

One crucial, yet often underestimated safeguard in this process is rigorous data verification.

This vital step bridges the gap between source data and authored content, acting as a safety net to catch discrepancies, inconsistencies, or outdated information that could otherwise have severe consequences.

Discrepancies between sources don’t just pose compliance risks or invite regulatory rejections; they can trigger costly submission delays, force rework, and even compromise patient trust.

Beyond immediate submission success, flawless data integrity instils confidence for long-term strategic initiatives, including post-approval lifecycle management, divestments, and seamless technology transfers, adding an invaluable layer of reliability to your product dossier.

As the regulatory landscape evolves, with new complexities such as the integration of Artificial Intelligence (AI) into data processes, mastering data verification is more critical than ever.

This blog explores why this often-overlooked step is essential and how a proactive, expertise-driven approach can transform potential pitfalls into a pathway for sustained regulatory success.

Why data verification is essential: Beyond basic compliance

Document version control and e-signatures establish accountability for updates to live documents, but they don’t inherently guarantee accuracy or real-time alignment of data with source records.

A dedicated, rigorous verification step proactively catches discrepancies in transcribed text, identifies outdated information, and ensures consistency when source documentation has evolved between authoring and final review.

Implementing robust data verification isn’t just best practice; it’s a strategic imperative that directly impacts compliance standing and, ultimately, patient safety.

Comprehensive data verification ensures:

• Patient Safety & Product Efficacy. Accurate data is essential for safeguarding manufacturing processes that directly affect the safety and efficacy of the final drug product. Verification acts as a final safeguard to protect those who rely on medicines.
• Data Accuracy and Consistency. Mismatches between LIMS data and regulatory submissions can lead to misinterpretation of product quality and safety. For example, discrepancies in stability data could raise concerns over shelf life and safety profile. Verification prevents such critical disconnects.
• Regulatory Compliance. Health authorities, including the FDA, EMA, and MHRA, emphasise data integrity through ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available). Discrepancies may trigger inspections, audits, or application rejections.
• Proactive Risk Mitigation. Detecting and resolving inconsistencies before submission minimises the risk of costly rework, health authority queries, delays, or product recalls and protects the company's reputation.
• Enhanced Operational Efficiency. A structured verification process reduces time-consuming back-and-forth between source data teams and Regulatory Affairs, helping maintain submission timelines and improving cross-functional collaboration.
• Continuous Process Improvement. Recurring discrepancies often highlight deeper process issues. Verification creates an opportunity to flag and address root causes, preventing repeat errors.
• Strategic Forward Planning. Reliable, verified data builds long-term trust, supporting future divestments, market authorisation transfers, and technology transfers, enhancing the value and marketability of assets.

Does AI make data verification redundant?

With the rise of Artificial Intelligence, some may assume verification can be fully automated.

However, removing human oversight from a step where accountability is vital introduces risk. AI tools may also pose data confidentiality concerns, with secure alternatives often costly and time-consuming to validate.

AI can be integrated into verification workflows to streamline processes, accelerate turnaround, and free up resources, but human verification remains essential to confirm accuracy and maintain accountability.

Beyond CMC: data verification in Clinical and Non-Clinical studies

While CMC data verification is critical, the volume, complexity, and direct patient impact of clinical and non-clinical data present unique challenges.

Ensuring unimpeachable integrity in these areas is fundamental to drug development and regulatory success.

Clinical data verification: Safeguarding patients and trials

Clinical trials generate vast amounts of sensitive data relating to patient safety, drug efficacy, and adverse events. Aligning data between clinical trial management systems (CTMS), electronic data capture (EDC) systems, and regulatory documents is essential to:

• Protect Patient Safety. Accurate reporting prevents adverse event misclassification and ensures proper risk assessment.
• Support Regulatory Assessments. Health authorities require consistent data across clinical study reports (CSRs), clinical trial applications (CTAs), and new drug submissions. Discrepancies can undermine entire development programmes.
• Maintain Site Compliance. Verification ensures trial sites uphold documentation standards and Good Clinical Practice (GCP) requirements, reducing audit findings and safeguarding site reputation.

Non-clinical data verification: The foundation of early development

Non-clinical studies, including toxicology, pharmacokinetics, and preclinical safety evaluations, underpin the scientific foundation of a drug. Verification is vital for:

• Toxicological Assessments. Ensuring animal study data reconcile with regulatory summaries to maintain accurate safety profiles.
• Method Validation Data. Confirming bioanalytical method results are accurately reported, supporting the reliability of drug concentration measurements.
• Study Reproducibility. Aligning data between lab systems and submissions strengthens scientific conclusions and prevents challenges to study validity.

Conclusion

Across CMC documentation, clinical trial data, and non-clinical reports, robust data verification is a cornerstone of regulatory success. It safeguards patient safety, preserves scientific integrity, and ensures compliance — enabling timely approvals while building trust for future growth and strategic opportunities.

Don’t let data complexity become a bottleneck or risk factor in your submissions.

Contact G&L Scientific today to see how our specialised expertise can transform verification challenges into a clear pathway for sustained regulatory success.

References:

• Divya Gokulakrishnan, Sowmyalakshmi Venkataraman, ENSURING DATA INTEGRITY: BEST PRACTICES AND STRATEGIES IN PHARMACEUTICAL INDUSTRY, Intelligent Pharmacy, 2024
• ALCOA+ - What does it mean?

Pádraig McKenna is a Senior Regulatory Executive at G&L Scientific.