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The 10 Essentials of Document Management for Biotechnology Companies

The 10 Essentials of Document Management for Biotechnology Companies

In the fast-paced world of biotechnology, where innovation hinges on precision and collaboration, efficient document management becomes a cornerstone of success. With mountains of research data, protocols, regulations, and intellectual property to...

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Tags: document management, Compliance, biotechnology industry, audit readiness

How to Get ISO 9001 Certified: A Step-by-Step Guide to Quality Excellence

How to Get ISO 9001 Certified: A Step-by-Step Guide to Quality Excellence

Ensuring your products and services meet the highest quality standards is essential for business success. An ISO 9001 certification is a powerful tool that not only demonstrates your commitment to quality but also enhances your ability to deliver...

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Tags: ISO 9001, Compliance, iso standards

Demystifying FDA CFR Part 11: A Guide for Life Science Companies

Demystifying FDA CFR Part 11: A Guide for Life Science Companies

For life science companies, compliance with regulatory standards is paramount to ensure the safety, efficacy, and quality of products and processes. One such critical regulation is FDA CFR Part 11, which governs the use of electronic records and...

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Tags: FDA compliance software, Quality Management System, 21 CFR compliance, Compliance, fda cfr part 11

10 Crucial Compliance Functions for Chemical Manufacturers

10 Crucial Compliance Functions for Chemical Manufacturers

The chemical industry operates under stringent environmental regulations to ensure the responsible and sustainable production of chemicals. Compliance with these regulations is essential for chemical manufacturers, as it not only protects the...

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Tags: chemical industry, Compliance, chemical manufacturers

GxP Compliance: A Comprehensive Guide to Achieving and Maintaining Compliance

GxP Compliance: A Comprehensive Guide to Achieving and Maintaining Compliance

In today's highly regulated industries, ensuring compliance with industry-specific standards and regulations is paramount. One such standard that plays a vital role in industries such as pharmaceuticals, medical devices, and biotechnology is GxP...

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Tags: Compliance, Document Compliance Software, gxp compliance

AI in Quality Management: How Artificial Intelligence Is Revolutionizing the Quality Process

AI in Quality Management: How Artificial Intelligence Is Revolutionizing the Quality Process

Quality management is a critical aspect of various industries, ensuring that products and services meet established standards and exceed customer expectations. As technology continues to advance, the integration of artificial intelligence (AI) is...

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Tags: Quality Management System, Compliance, AI, Artificial Intelligence

Top FAQs on FDA 21 CFR Part 11 Compliance

As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those...

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Tags: FDA Compliant Document Control Software, Compliance, fda guidelines, fda cfr part 11

The ROI on a Specification Management System: Is It Worth It?

The ROI on Specification Management System: Is it Worth it?

If you’re a packaging or manufacturing professional, you’ve likely experienced the frustration of spending precious time tracking down product/packaging specification data. The manual nature of managing specifications using spreadsheets, shared...

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Tags: specification management, Spec Management, ISO 9001, Compliance

5 Ways Laboratories Can Simplify ISO/IEC 17025 Compliance

Meeting the ISO/IEC 17025:2017 compliance standards is essential for testing laboratories. Not only does this regulation dictate lab competency, but it also helps demonstrate that your laboratory is performing at par with your internationally...

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Tags: Compliance, laboratory industry, iso 17025, ied 17025

Best Tips For Training Food & Beverage Manufacturing Employees

No matter the size of the company, food and beverage manufacturers should take employee training seriously. Not only does effective training help you create a quality product, but it also helps keep employees safe on the job, increase employee...

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Tags: training management system, Compliance, food and beverage industry, employee training