Data integrity in the pharmaceutical industry

Over the last couple of years, data integrity has been a hot topic during pharmaceutical company audits and inspections in the wake of regulatory modifications that have had an impact, amongst others, on computerised systems.

  • On March 2018, after 2 years of discussion, European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency UK (MHRA) – issued a document focused on data integrity that reinforces the concept of ALCOA+.
  • On August 2018 Parenteral Drug Association (PDA) issued the Technical Report 80 Data Integrity Management System for Pharmaceutical Laboratories. This report underlines the regulatory requirements and the best practices that can be followed to guarantee data integrity in physicochemical and microbiological laboratories.
  • On December 2018, the American Food and Drug Administration (FDA) issued a guidance document called ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers.’’ which highlighted the role that data integrity plays in the current Good manufacturing practice (CGMP) for drugs.

But why is data integrity so crucial? How can pharmaceutical companies ensure compliance? Let’s take a closer look at the topic:

  • Regulatory agencies and the pharmaceutical industry need accurate and reliable data to ensure safety, efficacy and quality of a product.
  • Data integrity is key to ensure trust between a company and the regulatory agencies.
  • Not every little part of all processes and the whole production can be constantly audited so regulatory agencies base some of their evaluation on the verification of the data integrity.
  • For regulators, Data Integrity must be a key part of Quality Management Systems, because companies use data to take GMP decisions.

Simply put, issues that may arise if data integrity is not met can lead to product recalls, regulatory incompliance, company image problems or even patient’s harm.

To illustrate, let’s focus on one of the first ALOCA+ requirement: the data attributability. This criteria implies that all collected data must be attributable to the person and/or equipment generating the data. To better understand this concept, take as an example the attached deviation issued by FDA inspection:  FDA Warning Letter 320-20-10 (December 2019). In the letter the FDA states:

“Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. (21 CFR 211.68(b)).”

One of the provided solutions is:

“Identify and evaluate vulnerabilities in performance and security of all of these computer systems, including but not limited to their configurations, administrative rights, password controls, audit trails capabilities and state of implementation for each system, qualification/validation status, deviation history, backup capabilities, network requirements, completeness of data records, suitability of current hardware/software for its intended use(s), change management, and management oversight.”

 As you can see data integrity, and specially accountability, is a pressing issue in the pharmaceutical environment. So, how does SherpaPharma approach the data attributability?

  • The system has several types of profiles so depending on their function or relation with the process they can do a specific set of actions.
  • There is a Supervisor profile who has access to the User Management feature and can create or inactivate the different users a company can have.
  • Each user has a unique CODE that is used to track all the activities that they have done in the system: from sampling to result reading.
  • Each user can have their own NFC Wristband code associated which helps to quickly, easily and securely identify each user when using the hand device. The wristband can be brought closer to the device to designate which user is using it and then register all activities.

NFC SherpaPharma Wristband can also be used for the Personnel sampling process. It helps to identify who is sampling and who is being sampled.

In SherpaPharma all activities performed into the system are easily attributable to a specific person and later can be tracked into the web site.