Verista 质量合规总监谈生命科学合规格局演变：数据完整性、CSA、序列化与网络安全

Robert Lucas, director, quality compliance, regulatory and auditing, Verista, discusses why life sciences leaders must rethink compliance as an integrated, continuously managed discipline to keep pace with evolving regulatory expectations.

The life sciences industry has always operated under close regulatory scrutiny, but the pace and complexity of compliance requirements have accelerated dramatically over the past decade. Driven by rapid technology adoption, globalisation, and increasingly sophisticated regulatory agencies, organisations can no longer afford to treat compliance as a static, box-checking exercise. The landscape is shifting in real time, and the companies best positioned for long-term success are those that recognise this and respond with proactive, programmatic strategies.

A landscape in motion

Four areas stand out as the most consequential forces reshaping compliance today: data integrity, artificial intelligence and machine learning, computer software assurance (CSA), and cybersecurity. What makes this moment particularly challenging is that these changes are unfolding faster than many regulatory frameworks were designed to accommodate.

Three primary forces are driving this transformation. First, the widespread adoption of electronic data systems, cloud platforms, AI-driven analytics, and connected devices has fundamentally outpaced the paper-based and standalone-computer frameworks that originally governed the industry. Second, regulatory inspections are exposing poor audit trails and data governance gaps that simply did not surface under older operating models. Third, and perhaps most encouragingly, regulatory bodies are demonstrating a willingness to adapt, successfully revising expectations and embracing new norms rather than clinging to legacy standards.

The result is a compliance environment that is dynamic, demanding a level of organisational agility that many life sciences companies are still working to develop.

Data integrity

No area of compliance has received more regulatory attention in recent years than data integrity. The FDA's final guidance on data integrity and compliance with drug CGMPs establishes a definitive framework: all data must be reliable and accurate, and firms must implement meaningful strategies to mitigate data integrity risk. This is an expectation.

At the centre of this framework is the ALCOA+ standard, which requires that data be attributable, legible, contemporaneous, original, and accurate. The "plus" extends these requirements to include completeness, consistency, endurance, and availability. Meeting the demands of ALCOA+ requires both procedural controls and a fundamental reconsideration of how data flows through an organization.

The industry response is coalescing around two activities: first, establishing a data integrity lifecycle by identifying inputs, outputs, security controls, and governance procedures; and second, building dedicated data integrity programs staffed by personnel specifically accountable for maintaining standards. This mirrors the shift that occurred in quality management when ISO 9001 moved from a documentation requirement to a full quality management system (QMS). Data integrity now warrants the same level of organisational commitment.

Computer Software Assurance

While traditional computer system validation (CSV) focuses heavily on documentation volume, computer software assurance (CSA) is pushing organisations toward a more risk‑based approach that aligns testing effort with intended use and critical functionality. For complex, integrated platforms, such as cloud‑based quality systems, machine vision solutions, and AI‑enabled tools, this means moving beyond simple installation and operational checks to demonstrate that the end‑to‑end system reliably supports GxP processes under real operating conditions.

Serialisation

Serialisation is another area where organisational maturity varies widely. Maturity matters here: the gap between compliance-as-checkbox and compliance-as-capability has real consequences. A mature serialisation program goes beyond simply meeting regulatory filing requirements, and in so doing, actively protects the supply chain.

The clearest marker of maturity is the presence of a robust exception management process. Immature programs discover problems through customer complaints—a reactive posture that leaves organizations exposed both to supply chain disruption and regulatory action. Mature organisations, by contrast, detect anomalies in the data stream before they escalate. They are actively reviewing for duplicate serial numbers and scanning for sequential anomalies and aggregate errors on an ongoing basis.

This proactive approach necessitates that serialisation be treated as a formal organisational function: documented, staffed, owned, and trained. Dedicated personnel in regulatory and quality departments should be responsible for identifying problems before and not after they compound.

Complexity beneath the surface

The increasing deployment of machine vision and automated inspection technologies on the shop floor brings significant compliance opportunities, but also significant risk, particularly for organisations that underestimate the complexity of these systems.

A common misconception is that validating a machine vision system means validating a camera. In reality, these systems encompass hardware, software, algorithms, and servers, and they integrate into broader operational environments in ways that create cross-functional compliance obligations. Under a CSA mindset, validation must therefore extend beyond the camera to cover the integrated system, its critical decision logic, and how it exchanges data with surrounding infrastructure. When organisations treat a vision system as a "black box," regulatory scrutiny becomes too one-dimensional, focusing primarily on quantitative results from only the hardware. A “white box” approach, however, makes this scrutiny more nuanced and better suited to ask and answer more meaningful questions: how does the software functioning underneath make pass/fail decisions? How does it interface with other systems? And how is it governed across IT and quality departments? Clear cross‑functional ownership between quality, IT, and operations is essential to avoid treating the vision platform as a self‑contained “black box” that no single function truly oversees.

This complexity also extends to vendor relationships. Vision system vendors are software companies with their own development and compliance histories. A thorough supplier evaluation should include questions about how the vendor developed and validated the system, what their notification process is for model updates and patches, and how they support ongoing compliance with validation requirements. Pushing accountability down to suppliers in this way while avoiding assumptions is a compliance discipline that is as important as it is overlooked.

Emerging risks across global operations

As supply chains expand across borders and more manufacturing partners come under regulatory scrutiny, a new set of compliance risks is emerging. Many of these risks lie below the surface of traditional audit programs.

Contract manufacturing organisations (CMOs) present a particularly significant gap in sub-tier supplier visibility. When a primary vendor relies on a CMO that has its own supplier network, oversight cannot stop at the first ring. Regulators increasingly expect not only evidence that sponsors audit their primary CMOs, but also that those CMOs operate their own risk‑based supplier audit programs with documented schedules and outcomes. The FDA has been increasingly explicit about its expectations for audit depth, and organisations that limit their due diligence to direct suppliers risk exposure from quality failures further down the chain. Maintaining an audit schedule that covers secondary and tertiary vendors is no longer optional for organisations operating at scale.

Cybersecurity represents an equally urgent and rapidly evolving risk. What was once considered an IT concern is now a GMP issue. Threat actors are targeting life sciences organisations for the exfiltration of proprietary and personal information, often by exploiting outdated systems that were never fully decommissioned but still contain valid credentials. Increasingly, attackers compromise backup servers first and only then move on to primary systems, eliminating the safety net organisations assume they have. For companies that have not yet built formal cybersecurity programs, the question is no longer if an attack will occur, but whether their operations can withstand it.

Building a proactive compliance posture

For organisations recognising that they need to raise their compliance game, the first imperative is often simpler than expected: go back to basics. Before pursuing new capabilities, verify that existing systems and programs are current. A QMS that met ISO 9001 requirements two decades ago cannot be assumed to meet today's standards. Just as ISO 9001 evolved from a documentation exercise into a fully embedded quality management system, domains like data integrity, cybersecurity, and serialisation now require formal, continuously maintained programs rather than point‑in‑time remediation projects. Management review, document control, training, internal and external audits, inspection readiness—these core ISO elements and FDA regulatory requirements are built into a compliant QMS by default. Still, organisations must periodically verify that their system reflects current expectations.

From that foundation, organisations should focus on developing or refreshing three core programs: a data integrity program that is reviewed and updated on a continuous basis rather than treated as a point‑in‑time exercise; a cybersecurity program built around recognised frameworks such as NIST's Cybersecurity Framework, with procedural controls including antivirus protections, third‑party penetration testing, and vulnerability scanning; and a serialisation program with the exception‑management infrastructure described above.

For cybersecurity in particular, the required shift in mindset is significant. Organisations that have historically operated reactively must recognise that the threat environment has instead made proactive monitoring a requirement. Managed security operations capabilities, including continuous monitoring of network traffic and IP activity, are increasingly necessary components of a defensible compliance posture.

The strategic value of experienced partners

As regulatory expectations continue to evolve and as technologies like AI and machine learning reshape every corner of the industry, the knowledge gap between organisations on the cutting edge and those still catching up is widening. The FDA has recently issued its first guidance for pharmaceutical companies on AI use, and bodies including GAMP-5 are actively working to establish frameworks. This pace of change means that even well-resourced organisations can struggle to stay current. For leaders who have spent decades navigating evolving expectations across big pharma, biotech, and medical device manufacturers, the through‑line is clear: regulatory expectations rarely stand still, and neither can compliance strategy.

This is where experienced compliance specialists are invaluable. For instance, Verista, a leading provider of automation, compliance, and quality solutions for the life sciences industry, brings deep expertise across the full compliance landscape, from data integrity lifecycle design and serialisation program development to CSA frameworks, cybersecurity strategy, and AI/ML readiness assessments that are grounded in day‑to‑day regulatory practice rather than theory. With hands-on experience conducting both external supplier audits and internal department audits, Verista understands how regulatory expectations translate into operational reality across complex, multinational organisations.

Critically, Verista is refusing to wait for the industry to settle on AI standards, instead choosing to apply AI tools within compliance functions today. For example, large language models can be used to compare a client’s existing quality procedures against ISO and FDA expectations, quickly surfacing gaps in SOP coverage, and to streamline management review by highlighting trends across audits, deviations, and training records. These capabilities are already delivering practical value to organisations navigating the transition from traditional quality models to AI‑informed compliance programs.

For life sciences companies looking to achieve regulatory resilience, the right partner brings both technical knowledge and the organisational experience needed to enact change. The compliance landscape will continue to evolve, shifting expectations around data integrity, cybersecurity, serialisation, and AI‑enabled systems. The organisations that thrive will be those that treat compliance as an integrated, continuously managed discipline, supported by partners who have already translated emerging regulatory expectations into practical, defensible programs.