Reliable Data, Reliable Products: Maintaining Data Integrity in Bioprocessing Workflows

Data integrity refers to data that are complete, accurate, consistent, and secure throughout their entire life cycle. The concept is essential for bioprocessing because it underpins demonstration of drug-product safety, efficacy, and quality. Regulatory agencies such as the US Food and Drug Administration (FDA) mandate strict data-integrity requirements. Specifically, Title 21 of the Code of Federal Regulations (CFR) notes that all data must be recorded and maintained accurately to ensure the safety and quality of drug products. Maintaining data integrity reduces the risk of recalls and ensures patient safety by mitigating the potential for adverse reactions. Moreover, data integrity prevents falsification and enhances confidence in drug manufacturers. In a 2024 Ask the Expert webinar, Shweta Nair (senior product manager for biopharmaceuticals at Advanced Instruments) talked about secure data recording and management during biomanufacturing processes.

Nair’s Presentation

ALCOA+ Principles: Nair noted that good documentation practices (GDPs) must follow ALCOA+ principles — that is, they must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Such principles guide biopharmaceutical companies in recording, tracing, and accessing data when needed. ALCOA+ principles also ensure that data are created and managed in a way that complies with regulatory standards.

In addition to US regulations, Nair discussed international standards for data integrity. The EU Annex 11 for good manufacturing practice (GMP) emphasizes the importance of computerized systems that meet regulatory requirements, and Chapter 4 of the GMP guidelines underscores the necessity for clear, legible, and contemporaneous record-keeping. Similarly, the World Health Organization (WHO) mandates that all data across a workflow must be captured.

OsmoTECH Instruments: OsmoTECH micro-osmometers from Advanced Instruments are designed to meet data-integrity requirements set by regulatory agencies. The instruments offer user logins with customizable passwords and three levels of access (supervisor, administrator, and operator) to control who can access data. Additionally, data collected by the osmometers are recorded contemporaneously and protected. The devices store unlimited data throughout their life cycles, allowing for easy access and integration with laboratory information-management systems (LIMS) and related information-technology (IT) infrastructure.

One key feature of the OsmoTECH portfolio of instruments is the ability to maintain an audit trail. Every user action is tracked, and no data can be deleted or altered. The osmometers support electronic signatures, enabling second-person reviews and approval of test data. The instruments also have built-in connectivity features for seamless data transfer to an organization’s data management ecosystem for review, archival, and compliance purposes. Automated backup functions further safeguard data integrity.

Advanced Instruments provides services to support data-integrity initiatives. Those services include installation qualification (IQ) and operational qualification (OQ) as well as training programs to ensure that teams are up-to-date on regulatory requirements. Nair stressed the importance of ongoing validation and risk-based assessments to maintain compliance with evolving industry standards. Collaboration with IT and data-integrity teams is crucial to meeting regulatory requirements and maintaining continuous business operations.

Advanced Instruments positions itself as a compliance partner for organizations striving to meet 21 CFR Part 11 and EU Annex 11 requirements. OsmoTECH osmometers and associated services are designed to help customers maintain data integrity across biomanufacturing workflows. By performing regular audits, backing up data, and staying current with technological advancements, biopharmaceutical organizations can ensure that their processes comply with regulatory expectations and that the associated data remain accurate, secure, and reliable throughout their life cycles.

Questions and Answers

Is the OsmoTECH osmometer a closed or open system? It is a closed system with embedded software to store data. Access to information is controlled by device administrators.

How often does calibration need to be performed? Advanced Instruments osmometers come factory calibrated and are recommended to be recalibrated as part of regular preventative maintenance schedules. We suggest that users complete verification before testing, either once a day or before running samples.

Find the full webinar online at www.bioprocessintl.com/category/webinars.