Why Are Signal Triage Logs Still Maintained in Spreadsheets?

Pharmacovigilance (PV) has evolved significantly over the last two decades. The discipline, once considered a regulatory necessity, is now a strategic function that helps pharmaceutical companies, biotech firms, and regulatory authorities ensure patient safety while maintaining trust in medical products. At the heart of PV lies signal management—the process of detecting, validating, prioritizing, and communicating potential safety issues from various data sources such as spontaneous reports, clinical trials, literature, and real-world evidence.

A critical step within this process is signal triage, the systematic evaluation of potential safety signals to determine which should advance for validation and in-depth assessment. To operationalize this, PV teams maintain signal triage logs—central repositories that record information about each signal under consideration, its source, decisions made, and rationale.

Despite technological advances and the growing complexity of PV data, many organizations still rely on one of the simplest tools available: spreadsheets. In 2025, this raises an important question: Why are signal triage logs still maintained in spreadsheets?

This blog explores the reasons behind this persistence, the challenges it creates, and how modern solutions like Tesserblu can transform signal management for the better.

The Role of Signal Triage Logs

Before diving into why spreadsheets dominate, it’s worth clarifying the role of triage logs:

• Central Record: They provide a snapshot of all potential signals detected across data sources.

• Decision Tracker: Each entry captures whether a signal was accepted, rejected, or flagged for further review.

• Audit Trail: Regulators require traceability of decisions, and triage logs offer a way to demonstrate why a signal was or wasn’t escalated.

• Collaboration Tool: Multiple stakeholders—PV scientists, medical reviewers, safety physicians, and quality teams—rely on triage logs to track progress.

In short, triage logs act as a nerve center of signal management workflows. Given this importance, why do organizations continue to use spreadsheets for such a critical activity?

Why Spreadsheets Dominate Signal Triage

1. Familiarity and Ubiquity

Spreadsheets are universal. Nearly every PV professional has used Microsoft Excel or Google Sheets at some point in their career. This familiarity lowers the barrier to adoption. Teams can start maintaining a triage log without formal training or procurement processes.

2. Low Cost and Accessibility

Spreadsheets come bundled with standard office software, making them a cost-free solution for organizations under budget constraints. For small to mid-sized companies or CROs, spreadsheets may appear “good enough.”

3. Flexibility

Signal triage often involves capturing highly variable data: case counts, MedDRA terms, literature citations, narrative text, review outcomes, and timestamps. Spreadsheets allow PV teams to design their own columns and fields on the fly without waiting for IT support or vendor customization.

4. Perceived Speed of Implementation

Implementing a safety database enhancement or dedicated signal management tool can take months, sometimes years, due to validation requirements, IT dependencies, and budget cycles. By contrast, a spreadsheet can be set up in a day.

5. Regulatory “Sufficiency”

While regulators such as EMA, FDA, and MHRA encourage structured, auditable systems, there is no explicit prohibition against using spreadsheets—provided they are validated, controlled, and compliant. For many organizations, this creates an incentive to stick with the status quo.

6. Legacy Habits and Inertia

Pharmacovigilance has traditionally been conservative, with high stakes around compliance. Teams often prefer “what has always worked” over experimenting with new tools. The phrase “better safe than sorry” is deeply ingrained in PV culture.

The Hidden Challenges of Spreadsheet-Based Triage Logs

While spreadsheets may seem convenient, their limitations become increasingly evident as PV operations scale or come under scrutiny.

1. Data Integrity and Human Error

Spreadsheets are highly prone to manual errors—accidental deletions, copy-paste mistakes, incorrect formulas, or misaligned columns. Even a small mistake could result in missed or mishandled safety signals, carrying regulatory and reputational risks.

2. Version Control Nightmares

In global PV setups, triage logs are often emailed back and forth between stakeholders. This leads to multiple versions, overwrites, and confusion about the “latest” file. Cloud-based sheets solve this partially, but not all organizations adopt them due to data security concerns.

3. Lack of Audit Trails

Although spreadsheets can track changes, they lack robust audit capabilities compared to validated PV systems. Regulators expect clear evidence of “who did what, when, and why.” Reconstructing such a trail from spreadsheets is cumbersome and error-prone.

4. Poor Scalability

As product portfolios expand and signal detection becomes more data-driven, spreadsheets quickly become unmanageable. A triage log with hundreds of rows, multiple tabs, and cross-linked formulas is not sustainable for long-term, multi-product operations.

5. Collaboration Gaps

Signal triage involves multidisciplinary teams across geographies. Spreadsheets offer minimal workflow management, task assignments, or notification features, leading to delays and miscommunication.

6. Validation and Compliance Issues

To be regulatory compliant, spreadsheets must be validated, locked, and controlled. This involves SOPs, restricted access, and change management processes—often creating an administrative burden that defeats the “simplicity” argument.

7. Limited Analytics and Insights

Spreadsheets are static records. They don’t provide advanced dashboards, visualizations, or analytics to track KPIs such as time-to-decision, signal prioritization trends, or reviewer workload. This limits organizations’ ability to move from compliance-driven PV to proactive, insights-driven safety strategies.

The Bigger Picture: Why This Matters

The persistence of spreadsheets is not just a technical inconvenience—it has strategic consequences:

• Delayed Decision-Making: Manual updates slow down signal triage, potentially delaying responses to true safety issues.

• Regulatory Risk: Authorities increasingly expect digital maturity in PV. Spreadsheet dependency could invite questions during inspections.

• Operational Inefficiency: Teams spend disproportionate time managing logs instead of analyzing signals.

• Lost Opportunities: Without advanced analytics, organizations miss insights that could improve patient safety, risk management, and product lifecycle strategies.

In an era where artificial intelligence, real-world evidence, and automation are reshaping pharmacovigilance, relying on spreadsheets is akin to using paper maps in the age of GPS.

Enter Tesserblu: A Modern Approach to Signal Triage

This is where solutions like Tesserblu come into play. Designed with the realities of pharmacovigilance in mind, Tesserblu helps organizations move beyond spreadsheets while preserving compliance, flexibility, and auditability.

Key Ways Tesserblu Helps

1. Centralized, Cloud-Based Triage Management

Instead of scattered files, Tesserblu offers a single, validated platform where all signal triage activities are logged, updated, and tracked in real time. Everyone works from the same version, eliminating version control chaos.

2. Structured Yet Flexible Framework

Tesserblu provides standardized fields for regulatory compliance but allows customization for organization-specific workflows. This balances flexibility with structure.

3. Built-in Audit Trails

Every action—whether a reviewer comment, decision, or timestamp—is automatically captured, creating a regulatory-grade audit trail with zero manual overhead.

4. Workflow Automation

Notifications, task assignments, and review deadlines are automated, ensuring signals don’t fall through the cracks. Teams can focus on decision-making, not file management.

5. Advanced Analytics and Dashboards

Unlike spreadsheets, Tesserblu offers real-time insights into signal volumes, decision timelines, reviewer performance, and portfolio-wide trends. Safety leaders can make data-driven decisions rather than reactive updates.

6. Scalable and Future-Ready

Whether managing a handful of products or a global portfolio, Tesserblu scales seamlessly. It also integrates with safety databases, literature monitoring tools, and case management systems, creating a unified signal management ecosystem.

7. Compliance by Design

Tesserblu is built to align with regulatory expectations, reducing the burden of validation and ensuring readiness for inspections.

Why Moving Away from Spreadsheets Is Urgent

The PV landscape is evolving rapidly:

• Data Volumes Are Exploding: With real-world data, social media, and AI-driven signal detection, the number of potential signals is increasing exponentially.

• Regulatory Scrutiny Is Rising: Authorities expect structured, documented, and auditable signal management practices.

• Patient Expectations Are Higher: Public trust depends on transparent, timely responses to safety concerns.

In this environment, clinging to spreadsheets is not just inefficient—it risks undermining patient safety and organizational credibility. Transitioning to a dedicated solution like Tesserblu is no longer optional; it’s a strategic imperative.

Conclusion

Signal triage logs are the backbone of pharmacovigilance signal management. Yet, despite their criticality, many organizations still rely on spreadsheets—a tool prone to errors, inefficiency, and compliance challenges. This persistence stems from familiarity, low cost, and regulatory sufficiency, but the hidden costs far outweigh the short-term convenience.

As pharmacovigilance becomes more data-intensive, globalized, and scrutinized, the need for modern, scalable, and compliant solutions is urgent. Tesserblu provides exactly that: a centralized, auditable, and intelligent platform that helps PV teams manage signals more efficiently, reduce risks, and ultimately protect patients better. Book a meeting if you are interested to discuss more.