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Data integrity compliance in the pharmaceutical industry

Pharmaceutical companies collect and analyze data throughout the production process to ensure end products meet standards for both quality and safety. For these companies to make informed business decisions and remain in compliance with regulations, the data they collect must be complete, accurate, and continuously protected from accidental and malicious alteration.


Defined as the process of maintaining the accuracy and availability of data throughout its life cycle, data integrity plays a critical role in any pharmaceutical manufacturing operation. If data becomes lost or inaccurate, your company could face fines, delays in product approval or even criminal charges. It is important to protect your manufacturing data at every stage of production and access — from initial recording through validation and archiving.


How you record process data helps determine its accuracy as well as its vulnerability to degradation. At COPA-DATA, we have designed our industrial automation software platform zenon to address pharmaceutical data integrity challenges so you can keep your data safe while improving production efficiency.


Common causes of data integrity challenges

The United States Food and Drug Administration (FDA) finds many data integrity lapses during inspections every year. Although most pharmaceutical manufacturers want to keep accurate records, they still struggle to manage risk and achieve compliance. Some of the common data integrity challenges that companies face include:

  • Record policies that deviate from requirements: The FDA and other governing bodies have strict expectations for pharmaceutical data integrity compliance, requiring companies to keep records that are records and principles that are attributable, legible, contemporaneous, original and accurate as well as complete, consistent, enduring and available. To avoid gaps in data integrity, manufacturers usually need to design their record policies and systems specifically to meet these requirements.
  • Insufficient data security controls: An important part of pharmaceutical data integrity involves keeping backups of data for security purposes. To meet FDA requirements, a backup must be a true copy of the original that is maintained securely for the required retention period. Without a proper backup, data can be accidentally deleted or rendered unusable due to improper alteration.
  • Lack of employee technical knowledge: Human error accounts for many data integrity concerns, and errors become more likely when employees lack the training and technical knowledge to maintain records properly.
  • Outdated procedures: Paper records no longer offer the best method for data maintenance. They can become illegible over time and are easier to tamper with than digital records. As a result, updating procedures can go a long way toward achieving data integrity compliance.

How zenon improves pharmaceutical data integrity

Used in a range of industries, zenon is a standardized industrial automation software with reporting and archiving features designed to keep your company in compliance. In addition to giving you the ability to easily create and run projects, zenon gathers the data you need to monitor every aspect of production.


Full compliance with industry regulations

zenon provides full compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 out of the box. To preserve data integrity, zenon provides a fully configurable out of the box an audit trail including eSignature capability, which ensures changes to records are always traceable to specific dates and individuals.


Other features that help zenon meet complex pharmaceutical industry regulations include user management, recipe handling, deviation detection, historian, and electronic batch reporting. With zenon, you can also export data to create additional backups.


No more paper lists

zenon allows users to record data digitally using mobile devices or directly at the machine panel, eliminating the need for paper checklists. The data entry application guides users through every step of the process and will not move to the next step until the information is complete and the figures entered are within specific tolerance ranges.


To prevent the human error common in paper documentation, zenon automatically detects incomplete, missing, and incorrect entries. When connected to sensors, zenon can even record some types of data automatically.

Use electronic data recording to move from a paper-based system to a digital one

Quick data reporting

zenon records pharmaceutical process data in electronic format, so data becomes available in real time. You can view information about the current batch while it's being produced and examine a report with quality documentation immediately after the batch is finished.


Quick data reporting enables you to detect errors while batches are still in progress. When zenon recognizes a problem, an alarm will notify the appropriate persons. By delivering complete data immediately after manufacturing, zenon significantly reduces the amount of time it takes for a batch to be approved and marketed, saving money in the process.


Simplify validation processes

With zenon, you can use electronic data recording to move from a paper-based system to a computerized one. zenon's read-only function eliminates the need to revalidate the existing process, allowing you to keep your existing machines and preserve your investment. Once you connect zenon to your current equipment, the read-only function will enable compliance with data integrity regulations.


Accurate and secure data archiving

Preserving pharmaceutical data integrity means keeping archived information accurate and accessible to users in the long term. zenon includes a database for generating detailed reports, as well as a central historian to increase visibility into your facility's operations.


Contact COPA-DATA for more information

zenon provides all the features pharmaceutical manufacturers need to improve efficiency and maintain compliance with data integrity standards. At COPA-DATA, we have over 30 years of experience in the industrial automation industry, and we use our experience to keep zenon up to date with all necessary logic and algorithms. As an independent software manufacturer, we have the ability to adapt to customer needs.


If you have questions about how zenon could improve your data integrity, contact us to request more information today.