Few industries are scrutinized by regulators as carefully as the pharmaceutical industry. Manufacturers of medicine should for example, be able to demonstrate at any time how they meticulously follow the Standard Operating Procedures (SOPs), and how patient safety is never compromised. But how do you ensure you have the most current, accurate, and complete data and can produce it in a timely fashion when an auditor or inspector suddenly shows up on your doorstep?
Internationally operating pharmaceutical companies, especially, have to deal with multiple regulators. A European manufacturer of medicines not only engages with national regulators, but also with the European Medicines Agency (EMA). The Food and Drug Administration (FDA) also wants insight into the company’s activities in the United States.
These regulators are often dissatisfied with the data that is presented to them. This becomes apparent from the warning letters sent to companies by the FDA. In 79 percent of the warning letters sent by the FDA over the past five years, the agency remarked on the lack of integrity of data, which makes it unreliable at best, and fraudulent at worst. In many cases, procedures and operations are poorly documented, making it difficult to follow or enforce. In other cases, data and electronic audit trails are accidentally or carelessly deleted with flimsy excuses such as lack of disk space.
Importance of Data Integrity
During an audit, a regulator is particularly interested in compliance with an organization’s own policies and procedures, adequacy of those policies and procedures, as well as with laws and regulations governing the industry in their jurisdiction. As an advocate for public safety, these regulators are obligated to ensure that organizations produce safe and efficacious medicines and follow well documented procedures.
It is important that data is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). Above all, it implies that the integrity of the data can be trusted, and that it is complete and accurate. A number of factors affect how the integrity of data can be assured, or, conversely, be compromised.
So how can organizations ensure that data integrity is assured and is in compliance with laws and regulations? These steps will help:
1. Focus on the People
By means of documented SOPs, employees are generally well aware of what they should do and how. But they should also know why it is important to do something in a certain way. Take, for instance, the direct registration of test results. There is always the temptation to quickly jot down a measurement on a piece of paper, and to register it later. This, however, jeopardises the contemporaneous principle of ALCOA. The moment of registration will no longer correspond with, for example, an instrument’s timestamp. People must be made aware of this and its importance. A good quality system entails much more than just documentation. It also enables people being trained to follow established procedures and efficiently completing their tasks whether it is executing tests or comprehensively investigating an incident.
2. Embrace a Digital Quality System
Both paper and electronic documents create a huge management challenge. Just think of version management. Is everyone indeed working with the latest version of a document? Or do these documents include the changes implemented after detecting compliance issues? Just working electronically is not enough. A digital quality system will ensure that everyone is always working with the most current, accurate, and complete information. A digital quality system will also support a seamless workflow of quality processes combining people and data that goes end to end with automated handoffs of data between workflows.
3. Strive for Digitally Connecting the Dots
Data is still often transferred/transcribed manually from one system to another. For example, from a lab instrument to a batch record document. Errors are invariably introduced during such transfers. Systems that are connected together will ensure that data is automatically transmitted between systems in a secure and validated manner. Where possible, build bridges to eliminate the need for manual recording and manual transcription. A connected system will also ensure that data is retrievable from a central platform and a single source of truth is achieved.
4. Ensure the Right Culture
It is important that quality is part of the company’s culture. The board of the organization or a governing body should stipulate this and exemplify it with its words and commitment. Core values such as honesty, integrity, and commitment to the highest ideals should be embedded into the organization’s DNA, and ALL employees must be held accountable for this. The tone at the top as well as a regular reinforcement of this culture will ensure that people recognize the importance and worth of their work and produce a product that consistently meets quality standards and compliance mandates.
All four of these aspects contribute equally to data integrity. Focusing only on the technical systems and ignoring the people and culture aspects is an underlying cause evident in many of the warning letters.
For more information about Dassault Systèmes work in the Life Science industry please see here.