> Navigating the Regulatory Landscape with ZONTAL
Data integrity is essential for achieving regulatory compliance in the life sciences industry. Even a single discrepancy in a regulatory submission can set an organization back by years, especially when consumer safety and public trust are at stake.
What is GxP?
GxP refers to a collection of good practice guidelines and regulations that ensure the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. The “GxP” acronym represents “Good [x] Practice,” where “x” can be replaced by various aspects of pharmaceutical operations, such as Manufacturing (GMP), Clinical (GCP), Laboratory (GLP), etc. [Wikipedia]
What is ALCOA+?
ALCOA is an acronym for Attributable, Legible, Contemporaneous, Original, and Accurate. It was later expanded to ALCOA Plus (ALCOA+) with the addition of Complete, Consistent, and Enduring. ALCOA+ refers to the data integrity principles established by the U.S. Food and Drug Administration (FDA) for pharmaceutical organizations seeking to achieve Good Manufacturing Practice (GMP) compliance.
Who needs to be concerned?
Modern labs often operate multiple systems that generate large volumes of data, sourced from instruments, software, and even cloud services. When relying on traditional data management system that is not GxP-compliant, organizations face a significant risk of failing audits.
In addition, evaluating the compliance of each individual source and system can make the audit process highly tedious — slowing approvals and creating unnecessary delays.
An organization that fails to comply with the regulatory framework is at high risk of causing consumer harm — leading to legal action, financial penalties, reputational damage, and, in some cases, product recalls.
The solution: Investing in the right data management platform means choosing one that stays current with the latest regulatory requirements. The ZONTAL platform is a GxP-compliant, cloud-based solution that delivers comprehensive scientific data management while enabling a robust, long-term data strategy.
Organizations aiming to rapidly transform their data landscape, enter new markets, prepare for upcoming audits, or submit regulatory filings will especially benefit from an advanced, holistic data management platform like ZONTAL.
Why is the traditional data management system likely to fail the GxP audit?
- Lack of a single source of truth: The presence of multiple systems and sources — such as ELNs, LIMS, file shares, and other instruments — introduces costly errors into the data ecosystem. This issue is further compounded in labs that rely on manual workflows in their day-to-day operations.
- Audit Trails are absent or unreliable: Compliance audits require dependable audit trails that trace present-day data to its provenance along with all operations performed on it in the interim. Without this capability, organizations are forced to manually reconstruct the history of a data point — often resulting in incomplete or unreliable records.
- Inherent data losses: Decommissioning legacy software can result in permanent data loss, making some historical experimental data inaccessible and creating gaps during audits.
How does ZONTAL make data ALCOA+ compliant?
ZONTAL automatically makes your data ecosystem ALCOA+ compliant, which implies that the data is:
- Attributable: The complete data lineage is seamlessly and automatically captured, ensuring traceability back to the origin and the individual who generated the data.
- Legible: As ZONTAL is aligned with the Allotrope Framework, all the data is stored in a readable and understandable format to support long-term use.
- Contemporaneous: Every data operation is recorded in real time and time-stamped, with an easily accessible audit trail available for view.
- Original: While ZONTAL enables data processing and analysis, the original raw data is securely stored, treated as immutable, and always accessible.
- Accurate: The recorded data is complete, truthful and fact-based, ensured through format validation by ZONTAL.
- Complete: Every data operation is recorded with full context, visible in the audit trail a cornerstone for meeting 21 CFR Part 11 requirements.
- Consistent: Data is recorded, time-stamped, and presented in the predetermined order established at the outset.
- Enduring: ZONTAL follows the Open Archival Information System (OAIS) Reference Model, ensuring all datasets remain available for use and reuse over time.
- Available: ZONTAL stores data in open-source formats, guaranteeing accessibility throughout the defined retention period.
How does ZONTAL make auditing easier and more effective?
ZONTAL securely preserves data, ensuring data integrity, error-free data transfer, prevention of regulatory audit failures, and facilitation of effective audits.
It supports a data strategy that reduces costs and frees up resources for critical issues, as personnel no longer require extensive compliance training.
ZONTAL’s analytics capabilities enable the creation of dashboards to quickly identify and address non-compliance issues.
Comprehensive documentation, binding electronic signatures, granular access control, and immutable audit trails allow ZONTAL to maintain electronic records and signatures in a manner considered trustworthy, thereby accelerating the audit process.
The Way Forward: A Data Strategy that Enables Data Intelligence
With the ever-increasing volumes of data generated in life science labs, the complex regulatory landscape, and the growing need for AI/ML-readiness, it’s time to consider a GxP-compliant, Findable, Accessible, Interoperable, and Reusable (FAIR) data management platform that takes a proactive stance towards compliance. Such a platform makes organizations audit-ready within weeks but also ensures that audits proceed smoothly and effectively. It is a proven way to streamline drug approval, advance the frontiers of science, and bring biopharma products closer to their target consumer markets.
To learn more about how GxP-compliant ZONTAL can help you navigate the regulatory landscape, contact us today.
