Security & Compliance

Unlocking the Power of Digital Contracts: Legal Validity and Enhanced Security

In the digital age, the business landscape is undergoing a profound transformation.

Guarding Against Identity Theft in Online KYC: Tips and Solutions

In today’s digital age, online video KYC (Know Your Customer) has become a crucial component of identity verification processes for businesses a

Achieving Business Compliance: A Deep Dive into KYC Practices | MSB Docs

In today’s global business landscape, where transactions cross borders and industries seamlessly, the need for robust compliance measures has ne

Achieve Total Quality Mgmt – Complete Guide to ISO 13485 Certification

ISO 13485 certification is an internationally recognized set of standards aimed at ensuring that medical device manufacturers have implemented stringe

Unveiled: A Guide to What is FDA 21 CFR Part 111?

The Food and Drug Administration (FDA) created 21 CFR Part 111 in 2007 for the purpose of regulating dietary supplements.

Uncovering the Regulator: Exploring the Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is the Australian Government agency responsible for regulating therapeutic goods including medicines, medic

Discover What is ISO/TS 16949 & IATF 16949 & Why it Matters

ISO/TS 16949 and IATF 16949 are two important standards recognized globally for automotive-specific Quality Management Systems (QMS).

What is 21 CFR Part 606? An Essential Guide to FDA Compliance

The FDA 21 CFR Part 606 regulations are designed to regulate the safety of both food and drug products.

Unpacking the Regulations: Understand 21 CFR 1271

21 CFR 1271 is a regulation set forth by the US Department of Health and Human Services (HHS) that addresses the manufacturing, processing, and labeli

Unveiling the Mysteries of 21 CFR Part 820 & ISO 13485

The 21 CFR Part 820 is a quality system regulation (QSR) issued by the United States Food and Drug Administration (FDA) which governs the design, manu

21 CFR Part 11: Open vs Closed Systems – What’s the Difference?

The 21st Century Cures Act (21 CFR Part 11) is a US Food and Drug Administration (FDA) regulation on the security and integrity of electronic records

Unraveling Regulations: 21 CFR Part 11 vs EU Annex 11

In today’s digital age, organizations must be equipped to manage electronic records in a consistent, secure manner. In order to achieve this obj

Compliance with HITRUST: What It Is and Why It Matters

HITRUST certification is a highly-regarded IT security and compliance certification program. HITRUST stands for Health Information Trust Alliance, and

Discover What Healthcare Compliance Means & How to Implement It

Healthcare compliance is the practice of making sure that organizations follow all laws, regulations, and policies related to the healthcare industry.

Master the Basics: Unlocking the Power of eMandates

An eMandate is an electronic authorization for direct debit payments. The system is designed to streamline the payment process, reducing administrativ

Unlock HIPAA Compliance: The Complete Guide

The Health Insurance Portability and Accountability Act (HIPAA) is a standard which all healthcare providers, organizations, and insurance companies m

USP & FDA to Make Critical Updates to Good Storage & Distribution Practices

This blog post will discuss the proposed updates to Good Storage and Distribution Practices from the United States Pharmacopeia (USP) and the Food and

Need to Respond to FDA 483s? Here’s What You Need to Know

FDA 483 observations (or “Form 483s”) are issued by the Food and Drug Administration (FDA) when findings of a GMP (Good Manufacturing Prac

Discover What GxP Compliance Audits Are & Who Performs Them

GxP independent compliance audits are processes developed to ensure that companies adhere to certain standards of quality, safety, and regulatory comp

Ready for Clinical Trial GCP Audits? Here’s What You Need to Know

A Good Clinical Practice (GCP) audit is an important part of clinical trials that ensures that the methods used and data collected are meeting certain

An In-depth Look at Integrity & Reliability in Bioequivalence Studies

Bioequivalence studies are an important process for ensuring that the pharmaceutical products produced by drug companies meet regulatory standards, su

FDA Announces New Reg. for Easy-to-Understand Medication Info for Patients

When it comes to taking medications, it’s important to understand what you’re consuming and the possible risks associated with doing so.

Get Ready for the International Recognition Framework (IRF): Understand Your Commitments

The International Recognition Framework (IRF) is an important tool for organizations as it sets out requirements for compliance with international sta

Take a Peek Into Common Critical Findings Found in Compliance Auditing

Compliance auditing is an important component of regulatory compliance. It involves a thorough review of procedures, processes, and records to ensure

Discover What the Drug Supply Chain Security Act (DSCSA) Means for You!

The Drug Supply Chain Security Act (DSCSA) is a law of the United States that was passed in 2013 to create a national system for the regulation and co

Unlocking AML Guidelines: IRDAI AML/CFT Compliance in Insurance

In the ever-evolving landscape of the insurance industry, staying compliant with regulatory guidelines is paramount.

Demystifying SEBI’s 2023 Cloud Framework Guidelines

In the rapidly evolving landscape of financial markets, the Securities and Exchange Board of India (SEBI) stands as a formidable guardian of inte

RBI’s Latest Regulations: Safeguarding Digital Lending Against Malpractices

In today’s fast-paced digital age, the financial landscape is undergoing a significant transformation.

Unlock the Benefits of FDA ISO 13485 and 21 CFR Part 820 Harmonization

The U.S. Food and Drug Administration (FDA) is the governing body that regulates medical device manufacturers.

Unlock Compliance: Uncover GAMP 5 for GxP Compliant Computer Systems

GAMP 5 stands for Good Automated Manufacturing Practice (GAMP) 5, an important concept in the GMP industries.

Unlock Your Auditing Career: 7 Essential Skills for GMP Internal Auditors

Internal auditing plays an important role in Good Manufacturing Practices (GMP). GMP Internal Auditors must have certain essential skills to perform t

Unlock the Keys to Good Manufacturing Practices: A Guide

GMP stands for Good Manufacturing Practices and it is a rigorous set of regulations that must be followed by companies who are involved in the product

Navigate CSV Traffic Jams with Validation 4.0: How to Automate Compliant Document Delivery

Validation 4.0 is a new system designed to help teams deliver documents and content quickly while still maintaining regulatory compliance.

Secure Your ChatGPT & AI Tech – Uncover Security Threats & Mitigate Risks

ChatGPT is an AI chatbot technology developed by OpenAI, a San Francisco-based company. It uses natural language processing to generate human-like res

Uncover the Fundamentals: A CISOs Guide to FedRAMP

FedRAMP is an acronym for the Federal Risk and Authorization Management Program. Devised under a collaborative effort between the government, industry

Discover the Top Compliance Challenges Facing Fast-Growing Businesses

Compliance is an important issue for all companies, but it can be especially challenging for fast-growing companies.

Unpacking the Differences: ISO 9001 vs ISO 13485 for Medical Devices

ISO 9000 is an international quality management system (QMS) standard, and ISO 13485 is a QMS Standard specifically designed for medical devices.

Unlock the Secrets of 21 CFR Part 11 Compliance for Medical Device Mfgs

21 CFR Part 11 is a set of regulations developed by the United States Food and Drug Administration (FDA) to enhance the protection of electronic recor

Master FDA 21 CFR 820 Compliance: The 6 Biggest Risk Areas in 2023

The regulation and compliance of FDA 21 CFR 820 is an important element for any organization or company that produces, markets, stores, distributes, o

Pass Your ISO 13485 Audit: All You Need to Know!

ISO 13485 is a global quality management system (QMS) standard used by medical device manufacturers.

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