Security & Compliance

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[…]

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

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

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

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

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

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

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

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

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

[…]

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

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

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

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

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

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

[…]

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

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

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

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

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

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

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

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

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