Enabling GxP Compliance
for Non-GxP Instrumentation
Introduction
In the pharmaceutical industry, data integrity is not optional—it is a regulatory necessity, a cornerstone of patient safety, and increasingly, a strategic differentiator for technology providers. As regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) continue to emphasize robust data governance, instrument manufacturers must ensure their systems can support compliance both in data acquisition and management.
The principles of data integrity are formally captured in the ALCOA+ framework, which states that data must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. These principles are foundational to good scientific practice and are enforced across global pharmaceutical operations.1
Since 2020, the U.S. FDA has issued an average of 304 warning letters per year with citing data integrity issues (approx. 24% of violations in 2016), many involving analytical instrumentation and laboratory software not designed with compliance in mind.2 In 2024, the FDA issued 70 warning letters, with at least 3 specifically citing data integrity violations at pharmaceutical manufacturing sites primarily due to microbiology and environmental monitoring where companies failed to ensure the integrity of the laboratory data.3 Common violations included deletion or manipulation of data, aborted sample analysis without justification, invalidated out-of-specification (OOS) results without proper investigation, and failure to document work contemporaneously. In one particularly illustrative case, inspectors found that a spectrophotometer used for finished product testing allowed files to be deleted without oversight, lacked audit trails, and had unrestricted administrative access. 4 Such issues, while seemingly technical, are interpreted by regulators as systemic failures to protect product quality and patient safety.
In today’s regulated environments, data generated by instruments must be trustworthy and traceable from the point of collection. Unfortunately, many common analytical tools, particularly those designed for research settings, were not built with 21 CFR Part 11 or Good Manufacturing Practice (GMP) in mind. For pharmaceutical manufacturers and contract organizations, this creates significant friction: data may be scientifically valid but fail to meet regulatory expectations.
This disconnect presents a clear opportunity for instrumentation vendors. By using synTQ Focus to drive their instrumentation, vendors can provide customers with a robust pathway to regulatory compliance.
synTQ Focus is a streamlined version of synTQ for single instruments. Like the full synTQ, it is a configurable, vendor-neutral, quality-centric knowledge management solution that provides a layer of compliance with 21 CFR Part 11 and the principles of data integrity on top of existing instrumentation and robotics. synTQ Focus enforces attribution, traceability and prevents accidental or malicious data deletion. Its key advantage lies in its simplified architecture for interfacing with a single instrument. This makes synTQ Focus ideal for enabling research-grade instruments to operate in regulated settings, allowing end users to generate audit-ready data from instrumentation and robotics they already trust. By extending the relevance of existing platforms, it accelerates customer adoption and enhances value in regulated workflows.
In a regulatory climate where compliance is a competitive differentiator, synTQ Focus equips instrument vendors to meet customer needs while maintaining product flexibility. synTQ Focus integrates GxP compliant instrument adaptors that facilitate continuous quality control improvements while supporting real-time data analytics. Analytical data can be fully integrated into GxP-compliant reporting, leveraging multivariate analysis tools for real-time monitoring and accelerated decision-making.
Key Benefits of synTQ Focus for End User Perspective
- GxP Enablement Without Reengineering
Add a compliance wrapper to your devices without modifying core firmware or acquisition software. - 21 CFR Part 11-Ready Architecture
synTQ Focus supports electronic signatures, audit trails, and secure data handling in alignment with regulatory expectations. - Agnostic Instrument Integration
Standard communication with OPC, web services, ODBC other protocols ensures compatibility with a wide range of devices. - Rapid Configuration and Deployment
Pre-configured orchestration schemas with editable parameter settings means no coding or specialist engineering is required.
- Multivariate Analysis and Real-Time Monitoring
Embedded analytics, with the optional tool of your choice, allows real-time monitoring of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), making your instrumentation a core part of advanced decision-making workflows. - Digitalization, Data Preservation and AI Readiness
synTQ Focus integrates with the SciY Data Platform, a broader digital ecosystem, making instruments and robotics more attractive to customers investing in end-to-end digital transformation. - System Qualification and Validation
A qualification package including IQ (Instrument Qualification), OQ (Operation Qualification) and CSV (Computer System Validation) can be ordered with systems driven by synTQ Focus.
Positioning synTQ Focus as your GxP enabler if you are an instrument vendor
Integrating synTQ Focus as a bundled or embedded solution empowers instrument vendors to meet the rapidly expanding demand for compliance-ready technologies within the pharmaceutical and biotech industries. With regulatory scrutiny intensifying, organizations are prioritizing GxP compliant instrumentation to ensure data integrity, streamline validation processes, and safeguard product quality.
By leveraging synTQ Focus, instrumentation vendors can address increasing demand for compliance-ready solutions in pharma and biotech. This enables vendors to extend their reach into regulated environments such as QA/QC laboratories, process development, manufacturing facilities, and tech transfer workflows, enabling seamless adoption within compliance-driven operations. The solution significantly reduces time and costs for end users by simplifying GxP validation requirements, ensuring that instruments integrate effortlessly into audit-ready digital workflows without cumbersome manual interventions.
Furthermore, synTQ Focus strengthens competitive differentiation in an increasingly crowded analytical instrumentation market, equipping vendors with a future-ready compliance strategy that aligns with the industry’s accelerating digital transformation. By embedding synTQ Focus within their product offerings, vendors not only enhance regulatory adherence but also position their technology as a strategic enabler for pharmaceutical organizations seeking scalable, compliant, and intelligent data ecosystems across global operations.
This approach supports the digitalization strategies of your customers while making your technology future-ready, compliant, and easier to deploy across regulated workflows.
Conclusion: Partnering for Compliance, Scalability, and Growth
This white paper explores how synTQ Focus, a no code interoperable software platform, empowers organisations to enhance GxP compliance, optimise workflows, and foster sustainable operations without the need for costly instrument replacements or complex system overhauls. By integrating existing assets into a digital, audit-ready environment, synTQ Focus supports long-term operational agility, regulatory adherence, and resource efficiency.
The market demand for data integrity and compliance-ready digital solutions is accelerating. synTQ Focus offers a powerful way to bridge the gap between non-GXP instrumentation and the stringent requirements of regulated operations.
For vendors, this means unlocking new value and differentiation. For customers, it means enabling GxP workflows without the burden of replacing or redeveloping their trusted analytical systems.
Partner with synTQ Focus and help your instrumentation go further into new markets, new workflows, and fully compliant, digitally enabled environments.
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References
- McDowall, R. D. Data Integrity: ALCOA+ Principles and Their Application to Laboratory Data. LCGC Europe 2018, 31 (6), 322–327.
- Ullagaddi, P. (2024) “FDA Warning Letter Trends: A 15-Year Analysis”, Journal of Pharmaceutical Research International, 36(10), pp. 14–23. doi: 10.9734/jpri/2024/v36i107585.
- Eckford, C. (2024) “FDA warning letters highlight data integrity issues”, European Pharmaceutical Review, https://www.europeanpharmaceuticalreview.com/news/219951/ fda-warning-letters-highlight-data-integrity-issues/
- Clegg, I. Data Integrity in the Pharmaceutical Industry: How Bruker BioSpin Can Help; Bruker BioSpin: Rheinstetten, Germany, 2021. Originally published via ValidNMR.com; https://www.validnmr.com/blog/ (accessed May 2025).
- U.S. Food and Drug Administration. Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry. https://www.fda.gov/media/97005/download (accessed May 2025).
- U.S. Food and Drug Administration. FDA Warning Letters Data Integrity Trends (2010–2023). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters
- EMA. Reflection Paper on Data Integrity. EMA/15599/2016. European Medicines Agency, 2016.
- ISPE. GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. International Society for Pharmaceutical Engineering, Second Edition, 2022.
