How Automating Processes Can Simplify Pharma Data Integrity Compliance

The age of industry and Pharma 4.0 has long been heralded, but many pharmaceutical companies are still reluctant to switch to fully automated processes. One reason for this is the fear that compliance with regulatory provisions, including those relating to data integrity in pharma, could suffer as a result. However, automation is a solution to counteract the challenges of the pharmaceutical industry’s rapid growth combined with the shortage of skilled workers. This article is intended to dispel the reader’s fear of automated processes and to show that investing in automated processes offers financial advantages and simplifies compliance with data integrity regulations.

Reliable and complete data in the pharmaceutical industry is essential for all pharmaceutical and Good-x-Practice (GxP) processes. The method of data collection has changed over time from purely handwritten documentation to manually entered data to fully automated data collection. Automating these processes makes work easier and reduces problems caused by the lack of skilled workers as well as the risk of transcription errors and other problems that can arise from handwritten documentation. Fortunately, the automation process also makes it easier to maintain data integrity in pharma.

This article sets out to answer the following questions:

• What are the most important data integrity regulations in the pharmaceutical industry?
• What is the PIC/S Guidance?
• What is US FDA 21 CFR Part 11?
• What is EU-GMP Annex 11?
• What is the framework used to comply with the regulations?
• How can automating processes simplify data integrity compliance?

Regulations on Data Integrity in Pharma

What is data integrity as it applies to the pharmaceutical industry?

Data integrity refers to the accuracy, completeness, consistency, and safety of data for the purposes of ensuring products efficacy, quality, and safety. It also refers to the processes, rules, and standards involved in regulatory compliance. As the main concerns with shifting towards automation are around data integrity topics and noncompliance, we will first focus on identifying current data integrity regulations and how automation can help organizations abide by them.

To ensure data integrity in pharma, there are three regulations that specify requirements for handling all data in a GMP environment: US FDA 21 CFR Part 11 and EU-GMP Annex 11 as well as the PIC/S guidance which assists in the interpretation of GMP/GDP requirements in relation to good data management and the conduct of inspections.

What is the PIC/S Guidance?

The Pharmaceutical Inspection Partnership (PIC/S) is an international association of GMP supervisory bodies that develops GMP guidelines for the pharmaceutical industry. Member states are governed by the guidelines of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperation Scheme (PIC/S Guidance).

The PIC/S guidelines are intended to help improve cooperation between regulatory authorities and the pharmaceutical industry in the area of good manufacturing practices.

What is US FDA 21 CFR Part 11?

In support of GMP, the US FDA 21 CFR Part 11 provides criteria for appropriately maintaining and submitting electronic records to the Food and Drug Administration (FDA)      and other federal agencies. Among others, it sets out the expectation that electronic records and signatures be treated the same as paper records and handwritten signatures. Compliance with Part 11 depends upon following certain quality controls that ensure data security, authenticity, and accuracy.

What is EU-GMP Annex 11?

Through Annex 11, the European Medicines Agency (EMA) lays out guidance for European Union members’ GMP around the use of computerized systems for recordkeeping. The requirements set by Annex 11 aim to mitigate any risk or loss in product quality due to the use of a computer over a manual reporting system. Much like the FDA document, EU-GMP Annex 11 offers operational best practices to ensure that electronic documents and signatures have the same validity as paper-based and handwritten records.

ALCOA+: A Framework for Compliance

In meeting the regulatory requirements, the ALCOA+ framework has become the gold standard.

What is ALCOA+?

It is the US FDA’s framework for ensuring data integrity in pharma. The acronym ALCOA+ stands for:

• Attributable: to specific employees via audit trails and eSignatures.
• Legible: for internal references and audits, as well as for regulatory inspections.
• Contemporaneous: so that the data are recorded at the time the work is carried out.
• Original: preserved in the format in which they were originally created.
• Accurate: using a system that minimizes errors and ensures raw data and analysis results are presented correctly.

The “+” further suggests that data integrity practices be:

• Complete: ensure everything is included and nothing is missing.
• Consistent: based on a system that enforces the use of approved data collection and analysis methods, report templates, and laboratory workflows.
• Enduring: use of media that ensure records are maintained and protected.
• Available: so that the recordings are accessible when needed.

The successful implementation of any automation process requires two elements. One, the systems must be valid. Two, the users must adhere to the requirements and receive adequate training in using the system.

How automation simplifies data integrity compliance

1. Associates data with the device on which it was created.

Attributable means that each record is uniquely linked to the source that created it. This can be a person or a specific measuring point. Through automation and appropriate programming, all data generated by a device or a system can be uniquely associated with the device and/or the person who created it or a data point from a specific time period. This is intended to achieve improved traceability.

2. Keeps data in a permanent readable format

The data must be legible and understandable. Handwritten paper documentation presented a risk to data integrity in pharma, as ink faded over time, paper aged, and one person’s handwriting could be hard for another person to decipher.

Modern cloud storage helps ensure data security and integrity even further as it is not dependent on physical storage such as hard drives, thumb drives, CDs, or other Media that could get corrupted. By automating your processes, you stand a better chance of data being retained in a durable, readable, and accessible format. Another benefit is that it can be more easily translated into different languages if needed.

3. Data are documented as soon as they are generated.

Contemporaneous data should be documented at the time of their creation. This is often not possible with human-collected data due to human delays or capacity. However, automated collection allows data to be recorded as they occur, which may be important in situations where the order in which data are generated is relevant to timeliness or traceability.

4. Generates and saves the data in their original format

The same automated processes that capture data the moment they are produced also mean they are able to generate and store the data in its original format.  This eliminates the need and expense of storing paper documentation. Data security can also be enhanced so that no one can access the information without proper authorization. With automation, user activity can be tracked, leaving an electronic “paper trail” that shows who and when did what, and ideally recording any changes (an audit trail or versioning), thereby preventing complete loss of information and ensuring data integrity in pharma processes.

5. Guarantees data accuracy, prevents transmission errors

Accurate within the framework of ALCOA+, includes both the exact time of collection and the correctness of the data collected. In terms of accuracy, automation allows each data source to be automatically calibrated and documented before it generates data. This simplifies the workload for the operator, reduces human error as manual calibration is no longer necessary, and guarantees that the data source always delivers correct data and no calibration can be skipped. The correctness of the data is guaranteed by automated processes, as manual data transfer is no longer necessary and transcription errors are thus excluded.

This also saves time since the data do not first have to be read out and, if necessary, noted on a paper before they get transferred to the digital filing system. In addition to avoiding typos, this also prevents calculation and rounding errors, which further increases the data accuracy.

6. Requires little effort to record and store all data

Within ALCOA+, the completeness of the data includes the recording of the results as well as the output data and the associated metadata. Process automation strengthens data integrity in pharma by allowing an operator to capture and store all data with little effort. When entering process data manually or by hand, various factors can lead to entries being forgotten or incomplete.

7. Provides a timestamp for each recorded value

Consistent refers to recording data in the correct order. The main benefit of automation in terms of consistency is that it eliminates the need for an operator to read and write the time from a possibly uncalibrated source. Instead, each recorded value is automatically timestamped. Furthermore, automation ensures that individual work steps always take place in a fixed order and the process can no longer vary from operator to operator.

8. Stores data permanently in digital form

The automation of processes ensures that data are stored directly and permanently in digital form. As previously mentioned, paper-based documentation is prone to corruption or loss, and the cost of storing documentation for long periods of time is significantly reduced. Furthermore, regular backups of the database can be created so that all data can be generated again in the event of a total failure.

9. Allows authorized users to access, use and process data

Automated data collection makes it easier for authorized users to access and use process data. Gone are the days of requesting access to paper-based documents, waiting for permission, and then waiting for delivery. Audits are also simplified as travel is eliminated and searches can be performed to extract desired information rather than sifting through pages of paper records.

A Final Thought

Process automation is no longer truly optional for pharmaceutical companies that wish to remain competitive in today’s marketplace. The efficiency organizations gain through the use of automated systems not only helps speed tasks to completion and products to market, but also can offset skilled labor shortages impacting virtually all organizations today. For organizations to grow and compete, automation is a necessity that cannot be ignored. Taking this step today will provide organizations with an advantage over competitors that hesitate to step into the pharma 4.0 marketplace.

Fortunately, ample support exists to simplify data integrity compliance through automated systems. Many solutions exist that make it easy to apply the principles of ALCOA+ while reducing the risk of noncompliance through manual recordkeeping.

Hopefully, you now have a better idea of how automating your processes can help maintain data integrity in the pharmaceutical industry. While initially some effort is required to create an automated system and integrate it with existing systems, it should be clear that automation facilitates compliance with all points of the ALCOA+ principle, eases the burden on employees, and ultimately leads to greater efficiency and leads to cost savings. Therefore, the recommendation at the end of this article is to set up new processes as automated as possible in order to prepare for the future and successfully enter the pharmaceutical industry 4.0.