Secure Healthcare Documents with HIPAA Compliant E-Signature Solutions | MSB Docs
In today’s digital age, the healthcare industry faces numerous challenges, and one of the most pressing concerns is ensuring the security and in
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
Uncover the Benefits & Challenges of Clinical Laboratory Improvement Amendments (CLIA).
Clinical Laboratory Improvement Amendments (CLIA) is a set of laws and regulations that are designed to ensure that all laboratory testing is performe
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).
Transition Your Medical Devices to New European MDR: Are You Ready?
Welcome to our guide on transitioning your medical devices to Europe’s New Medical Device Regulation (MDR)! This guide will provide an overview
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
Equip Your Drug Launch with Nitrosamine Regulations: Essential Guide
This guide is designed to help organizations understand and comply with the nitrosamine regulations related to marketing applications for new drug pro
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
Unlock Safety and Security with GVP: A Quick Guide
Good pharmacovigilance practices (GVPs) are procedures used to protect the safety of patients taking medications.
Uncovering FDA’s Nitrosamine Impurity Regulations for NDSRIs
NDSRI stands for Non-selective Dopamine Reuptake Inhibitor and is a type of medication used to treat depression and other mental health conditions.
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
Capture the Benefits: Transitioning from Early-Stage to Late-Stage Biotech
Biotechnology is one of the most transformative forces in the world today. It stands poised to revolutionize our understanding of science, medicine, a
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.
Understanding 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 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 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 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.
21 CFR Part 11 eSignature Compliance Checklist Here’s What You Need to Know About FDA Regulations (Updated)
Keeping sensitive data and private information secure is extremely important as well as complex
21 CFR Part 11 and Good Documentation Practices in Pharmaceutical Industries
It has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen.
UETA – Here’s What You Need to Know Before Going Digital
If you have stepped into the world of electronic signatures, you might have come across the acronym UETA a lot. This blog post talks about UETA and ho
21 CFR Part 11 Compliance Checklist
Every life sciences company that either sells or proposes to sell any kind of medical device has to follow the requirements under
Online Document Security & Privacy: Does it matter?
Almost every business sector has been affected by cyber-attacks in one or the other way. Especially IT, BFSI and healthcare sectors suffered
Does MSB Docs Conform with HIPAA Compliance?
Ink and paper are losing their momentum in many industries as almost every industry is trying to transform its processes digitally.
Gxp Compliance and Validation: How Going Paperless Saves Your Efforts
If you are running a business in life sciences or other regulated industries, you must be knowing what intensifying competition is. The shrinking marg
