Skillbee Solution

Announcement
A P J Abdul Kalam University Affiliated Institute & ISO 9001:2015 Certified Institute
Skillbee Solution
Follow us on Linkedin
Dashboard/ Login
Refer your friend
Become an Instructor
Skillbee Solution

admin

Why is LIMS Validation Essential for Your Laboratory?

Leave a Comment

Introduction to LIMS Validation Define LIMS (Laboratory Information Management System) and its significance in laboratories :- A **Laboratory Information Management System (LIMS)** is a sophisticated software solution designed to streamline, manage, and track all aspects of laboratory operations, from sample collection and testing to data analysis and reporting. LIMS is essential in modern laboratories across […]

Why is LIMS Validation Essential for Your Laboratory? Read More »

Cloud Computing

Leave a Comment

  Cloud Computing refers to “the online delivery of computing services – including servers, storage, databases, networking, software, applications, and analytics – over the internet (“the cloud”) as opposed to a local server or a personal computer.” Cloud computing allows businesses and individuals to access and store data and applications over the Internet with flexibility

Cloud Computing Read More »

The Future of Drug Regulatory Affairs: Trends, Opportunities, and Challenges

Leave a Comment

Introduction Overview of drug regulatory affairs and its significance in the pharmaceutical industry :- Drug Regulatory Affairs (DRA) is a specialized field within the pharmaceutical industry that focuses on ensuring that drugs, medical devices, and other healthcare products comply with the regulations and standards set by health authorities in different countries. Regulatory affairs professionals play

The Future of Drug Regulatory Affairs: Trends, Opportunities, and Challenges Read More »

What Is Computer System Validation (CSV) and Why It’s Crucial for Compliance

1 Comment

Introduction Definition of Computer System Validation (CSV). Computer System Validation (CSV) is the process of ensuring that computer systems and software used in regulated environments consistently produce accurate, reliable, and compliant results. This involves a series of documented activities that confirm the system meets its intended purpose and complies with relevant regulations and standards. CSV

What Is Computer System Validation (CSV) and Why It’s Crucial for Compliance Read More »

The Importance of Good Manufacturing Practices (GMP): How GMP Affects Drug Quality and Regulatory Compliance

1 Comment

Introduction Define Good Manufacturing Practices (GMP) in the context of pharmaceutical manufacturing:- Good Manufacturing Practices (GMP) in the context of pharmaceutical manufacturing refer to a system of regulations, codes, and guidelines that ensure products are consistently produced and controlled according to quality standards. These practices are vital for maintaining the safety, quality, and efficacy of

The Importance of Good Manufacturing Practices (GMP): How GMP Affects Drug Quality and Regulatory Compliance Read More »

Navigating International Regulatory Frameworks: A Guide to Drug Regulations Globally

Leave a Comment

Introduction Overview of the importance of understanding international drug regulations :- Understanding international drug regulations is crucial in today’s globalized world, where the pharmaceutical industry operates across borders and the movement of drugs, both legal and illegal, can have profound implications for public health, safety, and economic stability. The landscape of drug regulation is complex,

Navigating International Regulatory Frameworks: A Guide to Drug Regulations Globally Read More »

USFDA 483 on Access Management of Computerized System

USFDA 483 on Access Management of Computerized System

24 Comments

Observation   1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm manufactures over-the-counter (OTC) drug products, including alcohol-based hand sanitizers[1]. During the inspection of your facility, our investigator attempted

USFDA 483 on Access Management of Computerized System Read More »

DRUG REGULATORY AFFAIRS

DRUG REGULATORY AFFAIRS

2 Comments

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities’ attitudes and requirements etc. have a great influence on the drug development process and the success of it.

DRUG REGULATORY AFFAIRS Read More »

Top online institutes to get your "Computer system Validation training & certification"

Top online institutes to get your “Computer system Validation training & certification”

1 Comment

Our annual ranking on Computer System Validation (CSV) training institute aims to highlight the best providers of CSV training in India and Outside of India. The ranking is concluded after an in-depth analysis and a detailed process of vetting through various training institutes in India, US, Ireland, China and Rest of the word. We reached

Top online institutes to get your “Computer system Validation training & certification” Read More »

Category Of Software & Hardware As Per GAMP Guideline & their Validation

Category Of Software & Hardware As Per GAMP Guideline & their Validation

2 Comments

Category of software Application are categorized into following software categories as per GAMP 5 guideline 1. Category 1 – Infrastructure Software:- There are two types of software in this category: A. Commercially available layered software: – Software upon which applications are built or applications are developed to run under the control of this kind of

Category Of Software & Hardware As Per GAMP Guideline & their Validation Read More »