Upgraded Digital Solutions Can Preserve Data Integrity in the Pharmaceutical Industry

One Quality, Total Quality

data integrity

Increasing violations related to data integrity in the pharmaceutical industry have led to regulatory scrutiny. How can organizations comply with newly released guidance? Image source: Flickr CC user John Goode

The pharmaceutical industry is no stranger to regulatory scrutiny. From implementing metrics standards to penalizing sponsor firms for observed deficiencies at contract organizations, agencies have increased pressure on drug companies to focus on quality. Now, they’re drawing attention to another area: data integrity.

Earlier this year, the FDA released guidance covering data integrity in the pharmaceutical industry and compliance with cGMP. 1  The effort is not confined to the United States either. The European Medicines Agency (EMA) published their own version of data integrity guidelines last month.[2. “EMA Releases Data Integrity Guidance,” August 11, 2016, http://www.pharmtech.com/ema-releases-data-integrity-guidance]  These documents were drafted in response to the rising incidence of data integrity violations observed within the industry. Because these violations can have negative consequences, drug companies must take steps to preserve data integrity and maintain quality.

Poor Data Integrity in the Pharmaceutical Industry Can Have a Big Impact

Pharmaceutical quality data must be reliable and accurate. If a company relies on incomplete and falsified records to evaluate drug quality or fails to investigate and report quality control deviations,2  there is no guarantee that the drugs they manufacture meet required safety standards. The repercussions of such violations can include:

  • Warning letters: Regulatory agencies can issue a public warning outlining observed deficiencies in data integrity. After receiving these letters, it is in the best interest of drug companies to remedy the observed deficiencies. Otherwise, they may be subject to further scrutiny in the future, which may lead to other repercussions, including product recalls, rescinded approvals and more.
  • Import alerts: For overseas drug manufacturers, data integrity violations can result in limited access. Regulatory agencies may issue alerts, preventing the import of pharmaceuticals across international borders. This can be especially detrimental to sponsor firms who use overseas contract manufacturers. Such delays can disadvantage the sponsor firm’s position within the drug market.
  • Consent decrees: If drug companies consistently fail to comply with regulatory guidelines, they might find themselves subject to these binding agreements to avoid federal litigation. In addition to fines levied by regulatory agencies, consent decrees can cost affected firms millions of dollars in limited production, delayed drug launches, and third-party consultation fees as they strive to bring their facilities into compliance. But even as affected firms make efforts to remedy their nonconformance, the existence of a consent decree can have lasting negative connotations—especially with investors and consumers.


Digital-Based Strategies Can Maintain Data Integrity

The repercussions of poor quality and data integrity in the pharmaceutical industry can be severe and have a lasting effect. Guidances such as those released by the FDA and EMA are meant to emphasize the importance of data integrity in drug manufacturing, as well as outline their expectations of companies. To minimize the risk of violating these guidelines, firms need to implement strategies to preserve data integrity:

  • Documentation systems: Using outdated quality management systems can introduce human error and inefficiency. The automated built-in tools incorporated into digital quality management processes can minimize such issues. For example, non-value-added tasks can be automated, triggering alerts when processes fall outside of acceptable parameters and prompting the appropriate department to take corrective action.
  • Data access: Many violations related to data integrity have involved falsified data or deleted records. Part of this stems from reliance upon outdated paper-based systems that are vulnerable to alteration. Even so, electronic records can be subject to the same issues if their design does not support centralization and security. To minimize the risks of data tampering, companies can adopt tools that enable version control, review, and approval.
  • Data traceability: Data integrity emphasizes record traceability. Beyond time and date, quality logs should track other details, such as personnel who conducted a test or the reason behind a protocol adoption. When used in conjunction with items like product test result history or critical process parameter changes, pharmaceutical firms can effectively measure and analyze their quality standards. More importantly, they have a clear audit trail that helps their efforts to comply with regulatory guidelines.

With attention shifting to data integrity, companies must increasingly be able to guarantee the reliability and accuracy of their quality data. To do otherwise could leave companies vulnerable to data integrity and quality risks that increase their chances of noncompliance. As regulatory agencies mount their efforts to scrutinize quality in the pharmaceutical industry, organizations will need to implement solutions that enable their ability to meet compliance standards.

BIOVIA offers many comprehensive digital solutions for pharmaceutical companies seeking to meet regulatory compliance. The One Quality solution is a powerful collection of management processes that enable organizations to maintain data and quality integrity. It supports the management of quality documentation throughout its life cycle, including version control, review, and approval. The solution also helps organizations enforce GMP processes, tracking performance and quality data and offering analysis for areas of improvement. To learn more about how data integrity leads to quality and how implementation of a digital solution such as One Quality can help your organization—complete with real world examples of companies that have benefitted—please register for our live event, Data Integrity: A Requirement for FDA Compliance, Quality, and Beyond, or contact us today.

  1. FDA Releases Data Integrity Guidance,” April 18, 2016, http://www.pharmtech.com/fda-releases-data-integrity-guidance
  2. FDA Warns Two Chinese Drugmakers for Data Integrity Violations,” June 30, 2016, http://www.raps.org/Regulatory-Focus/News/2016/06/30/25251/FDA-Warns-Two-Chinese-Drugmakers-for-Data-Integrity-Violations/