Pharmaceutical Liquid Analytics: In This Digital Age, Why Are We Still Recording pH Data on Paper?

Digitizing audit trails in pharmaceutical liquid analytics offers numerous benefits for these regulated production environments. Moving from manual to digital audit trails for key parameters like pH, oxidation-reduction potential (ORP), conductivity and dissolved oxygen enhances compliance, improves data integrity and streamlines operations.

This blog explores the critical advantages of digitized audit trails, including enhanced traceability, real-time data insights and compliance with US Food and Drug Administration (FDA) regulations.

In this Xtalks Spotlight edition, learn from Ron Bridges, Business Development Manager at M4 Knick, as he discusses the benefits, implementation options and operational value of digitized audit trails, answering why the industry must leave paper-based processes behind.

Gain insight into how digitization ensures secure, unalterable data while enabling operational efficiency and reducing human error.

Why Digitize Audit Trails in Pharmaceutical Liquid Analytics?

Moving from manual to digital audit trails is vital for accuracy, compliance and efficiency in pharmaceutical production. Manual processes often lead to transcription errors and data inaccuracies, which can delay investigations and complicate FDA audits.

“There are many reasons why someone would want to digitize,” said Ron. “Whenever these pieces of data are captured, they’re written down, and then a lot of times that data is transferred to a digital system. But you’ve got transcription errors that can creep into that information.”

Digitizing audit trails eliminates these risks by directly capturing data from devices, such as automated pH systems, and transferring it securely to a distributed control system (DCS). This ensures unalterable, traceable data, which complies with FDA 21 CFR Part 11 requirements. As Ron noted, “The information is automatically and immediately transferred to the digital system,” reducing errors and streamlining compliance.

In addition to regulatory benefits, digital systems enhance operational efficiency, reduce human error and provide real-time data insights to improve product quality. Digitization is a critical tool for success in today’s regulated environments.

How Can You Digitize Audit Trails?

Bridges outlined three primary methods for digitizing audit trails:

1. Integrated systems: Devices like spectrometers, chromatography systems or automated pH systems can directly transfer data to a DCS, ensuring seamless and accurate data capture.
2. Cloud-based solutions: Storing data in a cloud system ensures it remains accessible and protected, even during hardware failures.
3. Middleware software: Acting as a bridge between hardware and DCS, middleware software transfers data efficiently without requiring full system integration.

Each solution ensures that data is secure, traceable and compliant while providing flexibility based on operational needs and budgets.

Unlocking the Power of Fully Digitized Audit Trails

Beyond regulatory compliance, fully digitized audit trails provide unmatched depth of insights. Key features include:

• Event tracking: Capture a sequence of events with timestamps and user information for traceability.
• Data integrity: Ensure that data, once recorded, remains unalterable.
• Reviewability: Simplify audits and investigations with clear, accessible records.

“Information on the user, access timestamps and what actions were taken are all protected and documented,” explained Ron. “Once it’s captured, it’s completely frozen, so even accidentally, the information can’t be changed.” This level of security and transparency ensures trust and reliability in pharmaceutical production.

Meeting FDA Expectations

The FDA prioritizes data integrity, security and traceability, making digitized audit trails essential for compliance. Digitized systems capture and store data securely in an unalterable format, ensuring the original data remains accurate and consistent.

“Data integrity is one of the big things [the FDA is] looking for,” explained Ron. “The original data that we captured is what they’re viewing if they have to take a look at that audit trail information.”

These systems also enhance security by restricting access to authorized personnel and tracking user activity, allowing auditors to trace actions to specific individuals easily. “If they need to ask someone a question, they know exactly who to go to,” added Ron.

Clear and organized digital audit trails streamline audits, simplify investigations and support proactive quality assurance, meeting FDA requirements while improving operational efficiency.

Operational Benefits: Efficiency, Real-Time Insights and Error Reduction

Digitization transforms the pharmaceutical production floor, offering substantial operational advantages:

• Efficiency gains: Eliminate manual documentation and reduce human error by automating data capture.
• Real-time visibility: Monitor processes in real-time, enabling proactive interventions.
• Error reduction: Identify and correct potential issues immediately to maintain product quality.

With enhanced efficiency, real-time monitoring and fewer errors, digitized audit trails are essential for maintaining high productivity and product quality.

In today’s digital age, manual paper-based systems for recording audit trail data are outdated and inefficient. Digitized audit trails offer modern solutions that enhance data integrity, compliance and operational efficiency. These solutions can transform pharmaceutical liquid analytics and align with FDA expectations, ensuring production processes remain efficient, secure and compliant.

The question is no longer “Why digitize?” but “Why are we still using paper?”

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.