How to Address Increasing Complexity in Regulatory Audits
Regulatory audits and inspections that result in less-than-successful marks for organizations in the pharmaceutical industry have increased in recent years—and the resulting loss of valuable time and money has begun to endanger cost structures for organizations across the industry spectrum.
The Increasing Stringency of Audits
The ever-increasing globalization of pharmaceutical development, research, and trials—combined with the increasing complexity of drug compounds—have amplified the burden of audit readiness.
Companies now must accommodate varying regulatory requirements and standards in several countries. This involves incorporating quality regulations and criteria from all countries in which an organization operates—a monumental responsibility—and staying continually educated on each country’s shifts in requirements.
Further, the growing complexity of drug compounds—particularly in biotechnology drugs—has led to an increase in the number of inspections and an increasing stringency in inspection requirements and standards.
Together, these two factors amplify the number, complexity, and stress of audits for pharmaceutical organizations—and increase the number of less-than-successful audits for organizations that have not become better prepared than ever before.
Top Causes of Less-than-Successful Audits
The causes of less-than-successful regulatory-agency audits are myriad. However, a recent paper from the European Medicines Agency indicates that there are several common factors in suboptimal audits across most organizations.
The paper found that the predominant causes of problematic audits centered on a lack of consistent quality-control procedures within the trial master file structure that included missing documents, repeated documents, and the inability for the audited organization to find requested materials.
The most commonly audit-cited documentation errors, omissions, and gaps are as follows:
- Missing process documentation and signed forms for informed consent
- Study records with inaccuracies and gaps
- Missing documentation for eligibility criteria
- Gaps in adverse-event review and reporting
- Lapses in evidence of approvals while study-related activities are underway
- Missing regulatory files for trial sites
- Missed neglected findings on areas to address during site audits—or no documentation of corrective actions
- Lack of documentation surrounding protocol adherence
Sponsors hold responsibility for trials; therefore, they have the responsibility for setting documentation standards and overseeing compliance with the standards they have set—which requires a formal and rigid set of processes set into place ahead of the trial’s commencement.
Given the liabilities involved in less-than-successful audits, sponsors must become increasingly stringent about these processes, standards, and compliance; in turn, they must become increasingly strict with the contract research organizations they employ during trial processes.
How to Improve Regulatory Audit Outcomes
In the current environment, managing the considerable cost and time involved in clinical trials has become more complex for pharmaceutical organizations than it ever has been in the past.
Improved process definition, management, implementation, and oversight—ensuring improved clinical trial documentation and data management—achieves improved audit outcomes.
In turn, reducing audit time, stress, cost, and success rates through improved data management achieves the following significant efficiencies in clinical trials, all of which save significant time and valuable funds, per a study in the Drug Information Journal:
- Reduced time to database lock
- Reduced unnecessary work
- Accelerated time to market
Yet this work takes time and funds. Organizations seeking to preserve their cost structures must somehow find a way to do more work surrounding audit and inspection readiness in less time and with lower costs than their current workflows.
The need for vender partners that can deliver a high level of quality control amid increasing complexity has grown.
It might be time for you to seek a vender partner to achieve these outcomes for your organization. Contact Shearwater Health today: firstname.lastname@example.org or 615-921-9510.
You’ll be impressed by how we can help you.