Close

Laboratory Data Gives Better Outcomes With Data Intelligence

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Related stories

Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

State of API & Peptide CDMO Capacity

Pharmaceutical companies planning peptide or complex small-molecule launches are...

What Goes Into Synthetic Urine? The Chemistry Behind Replicating a Biological Fluid

Synthetic urine sounds simple until you look closely at...
- Advertisement -

With the advancement when it comes to automation and new drug modalities, modern labs happen to generate more data than ever; however, turning data into intelligence is indeed another story. Lab leaders stress on making the data actionable or achieving data intelligence from their data pools. They know that their laboratory data can go on to help their businesses better; all they need is to harness it.

AI doesn’t give you the right intelligence automatically

Laboratory data happens to be fertile ground when it comes to AI. Data-driven quality control can go on to alert labs to instrument trends as well as deviations. Analyzing data can enhance resource allocation as well as budgeting and also go on to identify emerging patterns that surround degrading data or process integrity. Data can be actionable; it can go on to generate powerful insights, shape decisions, and at the same time improve business outcomes, and with AI, one can go on to extract greater insights from data than ever before. For instance, AI pattern recognition can help in process monitoring as well as optimization. But there also happens to be a risk. If AI models get trained on data that is biased or incorrectly contextualized, they can go ahead and generate biased results.

So as to reach digital maturity, labs require the right intelligence in so as to get the right intelligence out. The phrase garbage in, garbage out is apt here in this context when we say- bad data will lead to bad outcomes. Intelligence in, apparently, is all about making use of high-quality data, and at the same time, it is also about harnessing human intellect. In order to succeed, AI and ML need the right data as well as the right people who ask the right questions.

Begin with the right data

Garbage in goes on to include data having transcription errors or stripped of context; for instance, just inputting the method and results of an experiment sans the context of what the experiment is. But when we talk of AI or ML, garbage in can also go on to mean insufficient data. Typically, if a lab goes on to run an experiment and does not get the desired outcomes, that data happens to be archived but rarely retrieved for review analytically. But in ML models, data coming from failed experiments can go on to yield information that’s useful about how parameters interact. Models get more precise due to lots of data on what does and does not go on to achieve desired outcomes. Hence, intelligence in should go on to include data from successful experiment runs as well as assays and failures.

Apart from being accurate, high-quality data has to be absolute, comprehensive, present, and also unique. Complete data happens to have no missing entries, and metadata or associated data are also included. Next, the data has to be comprehensive for the questions that the lab looks to ask. For instance, attempting to come up with golden batches but only offering a dataset with laboratory information management system- LIMS data may go on to generate an inaccurate as well as biased response. A LIMS may only go on to have partial data, which would require pulling data from other sources within the lab for a more absolute picture. Data has to be present. Training an algorithm with out-of-date data can go on to produce an out-of-date answer. And finally, the data should be unique. If values happen to be accidentally duplicated, it may further bias the data.

Getting the right data to the right people

Next, for good data to be useful, it must be made available and should be intelligible to both humans as well as machines. Often, data gets stored in varied silos and formats; even high-quality data can be difficult to retrieve.

Many companies have started to funnel data across all systems into a single data lake. This collection of structured as well as unstructured data can go on to offer a single source for data-consuming algorithms. But this approach is resource-intensive and is no longer necessary. Newer tools are designed so as to provide access to data in spite of the data location, necessarily de-siloing the system architecture with no involvement of IT.

It is well to be noted that wherever data is stored, a well-architected data backbone goes on to add layers on top of the data so as to maintain integrity and also provide context for data from numerous sources. These architectures are often built surrounding the FAIR data principles: making sure that the data is findable, interoperable, accessible, and, at the same time, reusable. In the past, it often took a trained IT professional operating side-by-side with the subject matter expert in order to construct the complex queries required to gain the desired solution sets. New tools happen to be reaching the point where anyone can go on to learn how to construct meaningful queries sans knowing how to program. Putting low- and no-code tools in the hands of lab workers can speed process development as well as experimentation.

In the current scenario, AI and ML have become integral so as to enhance low- and no-code platforms, thereby making it easier for non-technical users to go ahead and also perform sophisticated data analysis. The synergy between AI and ML and low-code as well as no-code tools makes sure that high-quality data happens to be accessible and actionable, helping users with unique levels of expertise to go ahead and contribute to data-driven decisions.

Intelligence in and intelligence out go on to mean that outcomes get affected by the people looking for answers as much as by way of quality of the data analyzed. This is indeed true once a data backbone gets established and optimized, but it is also true going up to that point. When designing a data backbone, human intelligence happens to hold the key to ensuring that data gets optimally captured, contextualized, stored, as well as accessed.

Get the right people ask the right questions

Apparently, having the right people in the room when it comes to a big data project often goes on to mean having all the roles getting represented. Diverse perspectives aid in ensuring that the right questions are going to be asked internally. Which is the data that matters? Given those objectives, how should the data be organized? These are all the questions that may differ from lab to lab.

Bench scientists as well as technicians should get involved from day one of a new data strategy; very often they are best placed to gauge the challenging space and to qualify that the apt questions are being asked in the first place.

Business leaders and data experts are also crucial to ensuring that the architecture captures data in ways that can be queried to answer business questions and achieve the desired business outcomes.

It is well to be noted that the most successful labs often go ahead and partner with industry experts who comprehend scientific and process development business requirements and have data science skills as well as expertise and capabilities. These external partners, often, can also go on to serve as helpful training resources.

While the industry goes on to develop in digital maturity by way of wet experiments to in silico techniques, knowledge gaps as well as communication can be barriers. For all team members, a shared digital literacy foundation around how AI as well as ML models work is necessary; that foundation should go on to include a shared commitment to the significance when it comes to stewarding high-quality data. A shared vocabulary can go ahead and help stakeholders communicate well with one another and with technical partners pertaining to data architecture and feasibility.

While AI tools happen to be indeed democratizing access when it comes to insight, true data intelligence requires an intelligent approach right from the very beginning to the end, with high-quality, well-organized data that is supported by knowledgeable and thoughtful humans across every phase of the business.

Never miss a pharmaceutical headline

The pharmaceutical industry moves fast – stay on top of it with our must - read briefings.

  • The top pharma and life sciences stories, straight to your inbox
  • The biggest news, features, interviews, and analysis
  • Dedicated coverage of the key developments driving the global pharmaceutical sector

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Latest stories

Related stories

Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

State of API & Peptide CDMO Capacity

Pharmaceutical companies planning peptide or complex small-molecule launches are...

What Goes Into Synthetic Urine? The Chemistry Behind Replicating a Biological Fluid

Synthetic urine sounds simple until you look closely at...

Danaher Prepares to Introduce Advanced AI-Powered Laboratory

In a significant step for pharmaceutical research, Danaher has...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access theMedia Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Translate »