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What is a LIMS and Why Your Lab Needs One
Introduction A Laboratory Information Management System (LIMS) is a computer-based solution that is used to manage, track, and store laboratory information and data. It allows for the effective handling of samples, related data, workflows, and laboratory operations and is thus a critical tool in contemporary scientific settings. LIMS automates data gathering, maintains regulatory compliance, aids in quality control, and enhances the overall productivity of laboratory staff. I

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Nov 14, 20259 min read


Effective Techniques for Excelsheet Validation to Enhance Data Accuracy
In today's fast-paced world, accurate data is vital. Whether it's for financial reports, sales forecasts, or inventory tracking, the integrity of your data can directly impact business outcomes. Excel sheets, favored for their versatility, are commonly used for data management across many industries. However, human error, incorrect formulas, and inconsistent data entry can jeopardize data accuracy. This post will discuss effective techniques for Excel sheet validation that ca

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Nov 8, 20254 min read


Understanding SAP S/4HANA A Comprehensive Guide for Beginners in the Pharmaceutical Sector
Introduction The pharmaceutical industry operates under immense pressure to enhance operational efficiency while maintaining strict compliance with evolving regulatory standards. Balancing these demands in a highly competitive and innovation-driven environment presents a significant challenge for many organizations. As a result, more pharmaceutical companies are turning to advanced digital solutions to streamline operations, ensure data integrity, and remain agile in the face

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Nov 6, 202510 min read


Data Integrity in CSV: Aligning with ALCOA+ Principles
Introduction Data integrity is a cornerstone of compliance in the life sciences and pharmaceutical industry. As regulatory agencies such as the FDA, EMA, MHRA, and WHO place increasing emphasis on trustworthy and reliable data, organizations must ensure that computerized systems used in Good Manufacturing Practices (GMP) environments meet stringent standards. One critical area where this comes into play is Computerized System Validation (CSV) . CSV ensures that systems perfor

companyconnectc
Oct 8, 20257 min read


Regulatory Affairs in India: Trends and Opportunities
Introduction The Indian regulatory environment has a crucial role to play in the safety, efficacy, and quality of products and services...

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Sep 24, 20258 min read


Understanding FDA 21 CFR Part 11 and Its Role in CSV
Introduction FDA 21 CFR Part 11 is a significant regulation that oversees the utilization of electronic signatures and electronic records...

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Sep 20, 202511 min read


CSV vs. Computer Software Assurance (CSA): What’s Changing?
Introduction CSV (Confidentiality, Security, and Availability) and CSA (Cloud Security Alliance) are two key terms in the field of data...

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Sep 6, 202510 min read


Integrating Instruments with LIMS: Challenges and Benefits
Introduction A Laboratory Information Management System (LIMS) is an application software used to automate and manage laboratory...

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Sep 5, 20259 min read


Understanding Computerized System Validation
Introduction Computerized System Validation (CSV) is a critical process in regulated industries such as pharmaceuticals, biotechnology,...

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Sep 2, 202514 min read


Why CSV Matters in Regulated Industries
Introduction Computer System Validation (CSV) is an important activity in regulated environments that validates computer systems perform...

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Aug 25, 202512 min read


Essential Tools and Software for Regulatory Submissions
Introduction Regulatory submissions are essential elements in numerous industries, notably pharmaceuticals, medical devices,...

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Aug 21, 202510 min read


Ethical Challenges in Clinical Trial Submissions
Introduction Ethics in clinical trials is the cornerstone pillar that guarantees the rights, safety, and welfare of human subjects are...

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Jul 13, 202511 min read


How Digital Transformation is Changing CSV
Introduction Digital transformation refers to the strategic integration of digital technologies into all areas of a business,...

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Jul 6, 202511 min read


Understanding Data Warehouses, Data Lakes, and Data Lakehouses
Introduction In modern businesses, data storage and management have become critical to operational efficiency, strategic decision-making,...

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Jul 5, 20258 min read


Virtualization and Container difference
Virtualization Virtualization is the process of creating virtual replicas of computer resources like servers, storage, devices,...

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Jun 29, 20253 min read


10 Common CSV Mistakes and How to Avoid Them
Introduction Computerized System Validation (CSV) files are essential documents used to verify that computer systems perform their...

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Jun 28, 202516 min read


Resume Tips for Freshers Entering Regulatory Affairs
Introduction Regulatory affairs is a critical role in most industries, such as pharmaceuticals, biotechnology, foods and beverages,...

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Jun 7, 202514 min read


The Future of CSV: Embracing CSA and Risk-Based Validation
Introduction Computer System Validation or CSV is a methodology applied to verify that software and computer systems in the regulated...

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Jun 2, 202510 min read


How LIMS Transforms Laboratory Operations
Introduction A Laboratory Information Management System (LIMS) is a computer-based system that is intended to facilitate laboratory...

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May 3, 202510 min read


Comparing FDA, EMA, and CDSCO Regulatory Frameworks
Introduction Regulatory systems have a critical function in guaranteeing the safety, efficacy, and quality of drug products prior to...

companyconnectc
May 2, 202514 min read
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