2024-03-18 12:55
A Comprehensive Guide to Software Risk Assessment following Computer Software Assurance (CSA) Approach
As the pace of digital transformation and automation accelerates, t… Read More
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Fda’s New Computer Software Assurance – Impacted Sops Blog
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applying csvcsa principles
FDA’s New Computer Software Assurance – Impacted SOPs
2024-02-09 10:21
CSA vs. CSV: How They Differ in Terms of Processes, Standards, and Outcome in the Medical Device Industry
Article Context:
Computer System Validation
Computer Software… Read More
2024-02-02 12:02
Digital Twin Manufacturing: Your Sidekick for Maintaining the Validated State
Envision a not-so-distant future, when logging into your computer opens the door to an insta… Read More
2024-01-19 13:09
Challenges and Solutions for Achieving FDA 21 CFR Part 11 Compliance through CSV and CSA
Article Context:
FDA 21 CFR Part 11
FDA 21 CFR Part 11 Challenges
Navigating FDA… Read More
2023-12-08 06:11
Applying CSV/CSA Principles to Cybersecurity in Regulated Industries
In the intricate landscape of regulated industries, the synergy between Computer System Validation (C… Read More
2023-09-21 12:31
Digitalization in Manufacturing – Why it’s time to start your Transformation Yesterday
In the 18th century, Samuel Slater, often revered as "The Father of th… Read More
2023-08-24 10:37
The Future of AI/ML in CSA/CSV Software Verification and Validation
Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regar… Read More
2023-07-28 08:47
Validation of packaging and sterilization – What Manufacturers get wrong?
Packaging and sterilization validations are a critical step in the development and manufac… Read More
2023-07-19 09:22
CSA (vs) CSV: Major steps involved in the Validation Process?
For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Histo… Read More
2023-07-13 08:56
The Future of CSV and CSA in FDA 21 CFR Part 11 Compliance: Trends, Innovations, and Best Practices
Article Context:
21 CFR Part 11 Compliance
Computer System Validation… Read More
2023-07-10 08:55
Guide on How to Pass the FDA’s 5 Stage Goals to Launch Medical Devices to Market
Bringing medical devices to market is a highly complex, challenging, and regulated… Read More
2023-06-29 09:12
Computer Software Assurance (CSA) for Lab Systems | Applications and Risk Analysis
The significance of FDA Computer Software Assurance (CSA) cannot be overstated when it… Read More
2023-06-28 12:00
A Comparative Analysis of Scripted Testing versus Unscripted Testing
Article Context:
Scripted Testing
UnScripted Testing
Scripted (vs) UnScripted Testing
Introduction:… Read More
2023-06-28 06:59
Ensuring Data Integrity in Medical Device Industry: Techniques for Data Life Cycle Management
Article Context:
Tips for Data Management
Maintaining Data integrity for med… Read More
2023-05-26 12:26
Digital Agile CSA | How to leverage Agile project methodologies when validating computer systems?
Technology advancements have compelled organizations to alter business m… Read More
2023-05-03 04:40
Guide for achieving rapid success with QMS
Bygones are those days when quality management systems (QMS) were largely confined to expensive, on-site platforms designed spe… Read More
2023-05-02 05:43
FDA 21 CFR Part 812| Requirements | Inspection | Audit Checklist
One can test the medical device on subjects even though without receiving the approval to be sold in the… Read More
2023-05-02 05:18
IEC 62304 | How to Overcome the Challenges in Medical Device Manufacturing?
A functional safety standard called IEC 62304 addresses the secure development and upkeep of m… Read More
2023-04-18 05:34
FDA 21 CFR Part 312| Requirements | Inspection | Audit Checklist
The Food and Drug Administration (FDA) established a collection of rules and specifications known as 21 C… Read More
2023-04-18 05:30
Polarion ALM Software | How to ease FDA 21 CFR Part 11 Compliance with Polarion Software?
There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes… Read More
2023-04-05 05:11
Streamlining Your Workflow | A Guide to Polarion REST API
Polarion is a web-based application lifecycle management (ALM) platform that allows teams to manage requirement… Read More
2023-04-03 12:23
SaMD Audit Support | How to Address the Challenges with Software as a Medical Device (SaMD)?
Modern technology is always crucial to the advancement of the healthcare sect… Read More
2023-03-10 08:06
21 CFR Part 820 vs ISO 13485
ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is n… Read More
2023-02-24 04:44
FAQs on CSA & CSV: A New Transition For Fulfilling Software Assurance and Regulatory Requirements
FDA (Food and Drug Administration) issued a draft guidance to… Read More
2023-01-17 11:40
Importance of a Training Management System in a Life Sciences Industry
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Company Name… Read More
2022-12-02 10:07
How iQuality helps to avoid FDA Warning letters?
Article Context:
FDA Warning Letter
How to avoid FDA warning letters with iQMS?
FDA Warning Letter
FDA issues warning l… Read More
2022-10-28 10:08
ISO 9001 Document Control Checklist
Article Context:
ISO 9001 QMS
ISO 9001 Documentation Requirements
ISO 9001
ISO 9001:2015 requires a list of obligatory documents.
The… Read More
2022-10-26 07:05
ISO 9001 Quality Management System | Requirements | Purpose | Benefits | Life Sciences
Article Context:
ISO 9001 QMS
Requirements for a Quality Management System
Purpose… Read More
2022-09-30 11:43
iQTMS | Training Management System | Essential features of iQTMS
Article Context:
iQTMS
Part 11 Compliant Non-editable Audit Trails
21 CFR, Part 11 Complaint Electronic S… Read More
2022-08-24 12:04
FDA 483 observations and Warnings 2021 | What are the most common FDA 483 inspection observations?
August 24, 2022
Posted by: vishnu cn
Category: FDA… Read More
2022-08-24 10:39
How to Validate and ease Compliances related to CSA and CSV in Medical Device Industry?
Article Context:
What is CSA?
What is CSV?
CSA for Life Science Industry
CSA-CSV C… Read More
2022-08-24 10:39
CSA | CSV | How to Validate and ease Compliances related to CSA and CSV in Medical Device Industry?
August 24, 2022
Posted by: vishnu cn
Categories: CS… Read More
2022-08-09 12:06
Training Management System | How Training Management System helps to ease the training in Life Sciences Industry ?
Article Context:
Training Management System
FDA Quality… Read More
2022-07-26 09:03
RMP-Risk Management Plan | ISO 14971 Risk Management Plans for Medical Device Industry
July 26, 2022
Posted by: Bhawna Gupta
Category: FDA
No… Read More
2022-07-21 11:34
CAPA Software | What are the major functions of CAPA Management Software ?
July 21, 2022
Posted by: Bhavani Sanagavarapu
Categories: eQMS, FDA, iQMS, i… Read More
2022-07-21 11:34
CAPA in eQMS Software | What are the major functions of CAPA Management Software ?
July 21, 2022
Posted by: vishnu cn
Categories: eQMS, FDA, iQMS, iQua… Read More
2022-07-12 09:40
Document Version Control | Importance of Version Control in a Document Management System
July 12, 2022
Posted by: Bhavani Sanagavarapu
Categories: FDA… Read More
2022-07-07 09:16
ISO 13485:2016 – Important Facts to Know About Quality Management System
July 7, 2022
Posted by: Bhavani Sanagavarapu
Category: FDA
No… Read More
2022-06-27 10:36
Process Validation | US FDA Medical Device Validation Process | Why it’s Important?
June 27, 2022
Posted by: Bhawna Gupta
Category: FDA… Read More
2022-06-24 06:26
Document Change Control | Why is DCC a must-have process in life science industries?
June 24, 2022
Posted by: Bhavani Sanagavarapu
Categories: 21 cfr p… Read More
2022-06-22 11:25
Records and Documents in QMS | How can records and documents linking increase the level of quality?
June 22, 2022
Posted by: Bhavani Sanagavarapu
Categori… Read More
2022-06-08 11:24
Shipping Validation FDA Guidance | Is CSA applicable to Shipping Validation?
June 8, 2022
Posted by: Shanna McGovern
Categories: CSA, FDA
No… Read More
2022-05-17 07:41
FDA EUA | FDA Emergency use Authorization for Medical Devices
May 17, 2022
Posted by: Bhawna Gupta
Categories: FDA, iQuality
No Comments… Read More
2022-04-06 09:09
21 CFR Part 11 Compliance | Must-have features of Quality Management System
April 6, 2022
Posted by: Bhavani Sanagavarapu
Categories: 21 cfr part 11, F… Read More
2022-03-31 06:55
FDA Issues Proposal To Amend The Medical Device Quality System Regulation
March 31, 2022
Posted by: Jess DeArmond
Categories: FDA, MDIC
No Co… Read More
2022-03-24 10:29
Change Control | How to Manage a Change Management Process?
March 24, 2022
Posted by: Bhavani Sanagavarapu
Category: FDA
No Comments… Read More
2022-03-02 07:16
Medical Device Recall: How does US FDA recall Medical Device work?
March 2, 2022
Posted by: Bhavani Sanagavarapu
Categories: CAPA, FDA, iQuality, MDIC… Read More
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