Learning Management & Talent Development Insights
Latest trends, ideas and reports in the world of talent development, learning management and edtech
-
9 Tips To Comply with 21 CFR Part 11
For highly regulated medical device organizations and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for companies subjected to FDA inspections. Organizations must follow best practices for maintaining compliance and quality process by following the 21 CFR Part 11 regulation. However, as more […]
-
All you need to know about FDA Form 483 and Warning Letter
When you are working for a drug manufacturing unit, clinical trials facilities, or a medical device company, you can expect random and routine inspections by FDA. The FDA regulates food, medicines, vaccines, medical devices, cosmetics, and tobacco products. The riskiest stake a pharmaceutical company can make is to be questionable for its quality practices by […]
-
The 3 Q’s in Computer System Validation – IQ OQ PQ
Adopting a Computer Systems Validation approach for the various systems they use is easier said than done when it comes to FDA-regulated organizations. Managing the computer system validation process is often comprehensive, with many steps from beginning to completion. Even one failure in the process can lead to devastating consequences for patients and the organization, […]
-
FDA Transition to Computer System Assurance: The New CSV
The 2003 FDA guidance paved the road for implementation of efficient computer system validation for the pharmaceutical industry. Following that FDA guideline, the life science industry has become more efficient in validating computer systems and the documentation in order to comply with regulation, inspections, compliance, and audits. The FDA launched the Case for Quality in […]
-
What Is a Validated LMS?
You may have heard the term “validated LMS” being thrown around when it comes to various types of platforms. This is an industry-specific term that’s applied to organizations with certain requirements for compliance and other protocols. Does your organization manufacture food, drugs, medical devices, or anything chemistry-related? You might want to pay close attention to […]
-
Achieving Compliance with 21 CFR Part 11
As the world is moving towards digitalization at a faster pace, the use of the computerized system in the life science industry brought a new perspective in terms of using a software application. Going digital has changed the way data is stored and managed. The transition to paperless recording has had a huge impact on […]
