Posted on November 6, 2026
By Astrix Technology Group
Blog, Featured Content
ICH E6(R3) raises expectations for risk-based clinical trial oversight. Integrating EDC data quality signals with CTMS oversight decisions helps sponsors and CROs close accountability gaps, document corrective actions, and demonstrate how emerging trial risks are identified and resolved.
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Posted on November 6, 2026
By LabLynx
Blog, Featured Content
LIMS validation remains the laboratory’s responsibility, not the software vendor’s. Regulated laboratories must validate their systems for intended use, including configurations and workflows. Risk-based approaches support compliance with Part 11, Annex 11, and ISO 17025, while ongoing change control maintains validation throughout the system’s lifecycle.
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Posted on November 6, 2026
By CSols Inc.
Blog, Featured Content
Modernizing a legacy LIMS with STARLIMS v12.x helps laboratories reduce technical debt, improve system maintainability, and streamline workflows. Strategic migration planning, risk-based validation, and cross-functional governance support lower long-term costs and sustainable laboratory operations.
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Posted on October 28, 2026
By Astrix Technology Group
Blog, Featured Content
Astrix has acquired Daelight Solutions, expanding its pharmaceutical technology consulting services across clinical, regulatory, and quality operations. Daelight’s expertise in Veeva Vault implementations, data migrations, and compliance helps Astrix support life sciences organizations in modernizing technology and improving regulated operations.
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Posted on October 28, 2026
By SciY
Blog, Featured Content
See how connected laboratory workflows can bring greater control and visibility to sample tracking, data capture, and traceability. This on-demand webinar uses a real-world example to show how paperless processes can streamline lab operations while supporting compliance requirements.
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Posted on October 28, 2026
By CSols Inc.
Blog, Featured Content
CSols, Inc., is seeking a talented LabVantage LIMS Consultant to join our team and deliver high quality laboratory informatics solutions to our clients. If you enjoy working at the intersection of science and technology, and thrive in client-facing roles, we want to hear from you. Experience in the gene therapy space is a plus!
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Posted on October 28, 2026
By Astrix Technology Group
Blog, Featured Content
Life sciences organizations face growing operational, financial, and regulatory risks from ransomware, fragmented systems, and compliance gaps. Integrated laboratory informatics, regulatory expertise, and platform-neutral strategies help strengthen data integrity, improve inspection readiness, reduce technical complexity, and accelerate scientific development while supporting evolving FDA requirements.
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Posted on October 28, 2026
By LabLynx
Blog, Featured Content
Laboratories choosing between cloud and on-premises LIMS face three key constraints: administration, downtime, and budget. Security alone rarely settles the decision. Migration costs, offline access to QC rules, and instrument compatibility all matter. On-premises remains a practical choice for labs with sovereignty requirements, legacy connections, and dedicated IT staff.
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Posted on October 21, 2026
By CSols Inc.
Blog, Featured Content
CSols helps laboratories align strategic planning with AI-ready data infrastructure by connecting consulting, FAIR-compliant data services, legacy modernization, and instrument integration into a unified informatics ecosystem designed to support scalable automation and long-term growth.
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Posted on October 21, 2026
By Astrix Technology Group
Blog, Featured Content
Migrating from paper lab notebooks to an Electronic Laboratory Notebook (ELN) requires more than technical installation. A consultant-led roadmap helps life science organizations address regulatory compliance, protect intellectual property, validate digital systems, and build an AI-ready repository that supports collaborative discovery.
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Posted on October 21, 2026
By LabLynx
Blog, Featured Content
Under the TNI standard, a legal chain of custody procedure is required only when the customer requires one. Every environmental sample needs documented receipt criteria, identification, preservation and holding time checks, and a unique identifier that links results back to the person who received it.
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Posted on October 21, 2026
By SciY
Blog, Featured Content
Spreadsheets and inboxes may suit small to medium labs, until volume and quality demands increase. WebLab is a modern LIMS that provides an accessible step into digital workflows, with clearer sample tracking, fewer handoffs, and more controlled day-to-day operations.
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Posted on October 19, 2026
By LabLynx
Blog, Featured Content
Your new analyst’s training is signed off and she’s doing fine. Then the assessor asks for the assessment due six months after her first patient specimen, and the date she first reported alone. Competency is a dated record, not a course. See what CLIA, CAP and ISO/IEC 17025 expect it to show, and how to shorten time to sign-out safely.
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Posted on October 19, 2026
By LabLynx
Blog, Featured Content
The microbiologist’s last day is a Friday. The next Tuesday, the incubator calibration she ran every week for nine years doesn’t happen, and the log stays blank for eleven weeks. The SOP holds the method, but the exceptions leave with the person. See where those gaps hide, what assessors find, and how a one-afternoon audit can catch them first.
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Posted on October 19, 2026
By LabLynx
Blog, Featured Content
The PT report says unacceptable, the next round passes, and both pages go in the binder. But assessors look for the written investigation that belongs between them. One lab was cited in 2026 for a single failed PT event from 2023. See what counts as a failure under CLIA, TNI and ISO/IEC 17025, and what to check first, from clerical errors to the scheme.
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Posted on October 19, 2026
By LabLynx
Blog, Featured Content
Nine in ten US labs answer a failed control by running it again. The repeat passes, the record shows a pass, and the drift is still there for an inspector to find. See why repeats pass even when a method has drifted, what CLIA, ISO/IEC 17025, TNI and 21 CFR 211 actually require, and what a QC failure record needs before the next audit.
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Posted on October 14, 2026
By Astrix Technology Group
Blog, Featured Content
Join experts from Astrix and Veeva to explore four essential foundations of an AI-ready laboratory: cloud modernization, connected data, organizational change, and master data management. Learn how laboratory modernization can improve efficiency, strengthen data integrity, accelerate innovation, and prepare for AI-powered product release.
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Posted on October 14, 2026
By Kalleid
Blog, Featured Content
Kalleid partnered with a biotechnology company to lead a six-month Microsoft Copilot pilot, assess readiness, and support a secure, scalable enterprise deployment. The initiative included training, communications, community engagement, and an AI Center of Excellence to sustain long-term adoption.
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Posted on October 14, 2026
By Astrix Technology Group
Blog, Featured Content
A May 2026 study found that direct-to-patient virtual sites enrolled roughly six times as many participants as traditional sites, completed studies at a rate of 86.3% versus 35.7%, and reached database lock approximately four months faster. Decentralization can improve recruitment, retention, diversity, and timelines when built around patient access.
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Posted on October 14, 2026
By LabLynx
Blog, Featured Content
The FDA’s Food Traceability Rule now takes effect July 20, 2028, but major retailers have established their own traceability deadlines. Some require data on all food items rather than only those on the Food Traceability List, making retailer requirements an immediate priority for food manufacturers.
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