Setting a Data Strategy and Ensuring Data Integrity with Eusoft.Lab LIMS SaaS on Microsoft Azure Cloud
In today’s data-driven world, laboratory environments face increasing challenges related to managing vast amounts of data while maintaining its integrity and security. Laboratory Information Management Systems (LIMS) are instrumental in handling these complexities. Eusoft.Lab, a LIMS solution built on the reliable foundation of Microsoft Azure, offers a Software-as-a-Service (SaaS) model that provides robust data management […]
Case Study: Data Governance Framework for Clinical Operations
Developing a Data Governance Framework for Global Pharma Clinical Operations A global pharmaceutical company recognized the critical role of data in delivering patient-centered solutions and driving healthcare innovation. However, rapid advances in technology, increasing regulatory demands, and expanding data sources made it difficult to establish a cohesive and comprehensive approach to clinical data management. To […]
Introduction to Pharmaceutical Data Items and Their Structure
Structuring the data used in pharmaceutical reporting will reduce the time needed to create reports, eliminate the manual (human) verification of data tables, and ensure error-free submissions. The use of structured data is particularly powerful in Module 3, which includes large, complex sets of data related to product quality. Using a structured approach to data […]
How to Develop an Effective Data Governance Strategy in the Pharma and Biotech Industry – Part 1
Why Data Governance is Important More so than with other industries, developing an effective data governance strategy is critical for Pharma and biotech companies. It’s imperative that data is accurate, complete, reusable, and secure. Without proper governance, Compliance could be at risk with agency regulations. Data quality, accuracy, user access, reuse, and reliability may be […]
White Paper: Managing Data Integrity in FDA-Regulated labs.
New White Paper
On Demand Webinar – Best Practices for Conducting Data Integrity Assessments
On Demand Webinar from Astrix Technology Group – Best Practices for Conducting Data Integrity Assessments. This session will detail how, when and why labs should perform data integrity assessments to comply with FDA guidance.
White Paper – Data Governance Myths and a Foundation for Success
While artificial intelligence, machine learning, and analytics dominate the headlines, biopharmaceutical companies’ ability to benefit from these advanced technologies is typically limited by a lack of solid data governance. Despite these limitations, many businesses are hesitant to take the needed steps to develop a solid data governance foundation. This white paper discusses common data governance […]
Common Mistakes in Computer System Validation
Modern scientific laboratories increasingly rely on computerized informatics systems (e.g., LIMS, ELN, CDS, etc.) to process and manage data. To ensure product safety and effectiveness, it is important for these systems to be validated in a process known as computer system validation (CSV) to confirm the accuracy and integrity of processed data. Regulatory agencies like […]
6 Common Challenges of Paper-Based computer system validation (CSV) and How to Digitize Them
When it comes to computer system validation (CSV), organizations face several challenges when trying to meet critical regulatory requirements. This blog post will explore six of the most common challenges and provide tips on overcoming them. CSV is a complex standard that can be costly and time-consuming to implement, particularly if you’re validating on paper. […]
Navigating Global Regulations and Guidance Around Data Integrity Guidance
Data integrity provides assurance that data records are reliable and accurate. Regulations meant to ensure data integrity in pharmaceutical laboratories are found in several parts of 21 CFR governing GxP areas and have been enforced by the FDA for decades. While many of these regulations were initially developed for paper-based processes, 21 CFR Part 11 […]
Essential Components of Data Governance – Part 2
These are 2 of the essential principles that ResultWorks believe are essential to any data governance program’s success. Strive for Continuous Improvement The rollout of a data governance program is a significant milestone that enables the foundational framework and structure for an organization’s journey. But achieving the ultimate objective of proactive and effective data governance […]
Case Study: Data Governance – Disorder to Alignment on a Common Framework
Overview As life science organizations grow, so does the need for data governance. There is a requirement in this industry to ensure patient safety, and that entails a focus on the quality of products and compliance, which necessitates exceptional data quality. The challenge becomes how to best leverage people, process, and technology to gain control. […]