Digital Transformation Strategies in Clinical Research: People

Continuing the discussion about digital transformation strategies in clinical research, the People angle, which would be the most critical angle. Like any other business process reengineering, it is people who will make it success or failure. It is more important in digital transformation, because in effort to make people more powerful and effective, and, empower them with accurate data and insightful intelligence for correct decision making, in a way, we are also generating indirect fear –  making them irrelevant. In spite [...]

CSV and Documentation

CSV and Documentation

Each regulated record (is a GMP record) and should be periodically reviewed Strong SOP and Work instructions repository covering all working areas Templates for all documentation, processes – recommended, mandatory VMP for computer systems – mandatory for all who are regulatory audited and use the same for validation across for computer systems URS – always to be prepared by the user and then can be used to prepare/compare vendor URS, FS OQ – should also include for Data [...]

Digital Transformation Strategies in Clinical Research

When we talk about ‘Digital Transformation’, there are wide range of definitions – the simplest covers digitization of processes, to more complex one that talks about complete revamping and reimaging the business in the era of digital technologies. Of course, in terms of clinical research; when we talk about digital transformation; we are not thinking in terms of complete revamping and reimaging the business. The research which deals with human life and is done on human being; that makes the [...]

Controlled Cost effective CSV

Controlled, Cost-effective CSV

CSV is mandatory for implementation of software systems in a GxP regulated environment. And, it would incur huge costs if not handled adequately. With increasing number of software systems implemented in any organization, it becomes utmost important to check the costs at every step, especially of CSV. The CSV tools include the following: Mandate! To protect public health, safety To ensure consumers access to safe, effective, affordable medicines How? Regulations Guidance documents Regular inspections Enforcing actions Today… GMP violations & non-compliance Data integrity issues [...]

Memory-Management

Memory Management with .NET Part – 1. Basic

Memory management is a very vast concept and each individual can have different idea or way to implement this in different programming language. In this blog, we are going to see the details of memory management in respect to .NET. Well, .NET is one of the fantastic piece of software engineering. With this framework, user can write their code with no or little knowledge of fundamental. On the other hand difficult topic like memory management are taken care by [...]

Computer System Validation (CSV)

Significance of CSV in Life Science Industries & How is CSV approach related to SDLC?

Computer System Validation (CSV) is the practice of ensuring that any software or hardware which meets its purpose with regulatory guidelines. The pharmaceutical business model is emerging, and CSV is becoming even more crucial because of the increasing scope of information systems, more integrated functionality, consolidation, and archiving requirements. It helps companies to maintain its quality standards. US FDA defines CSV as establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting [...]

Microsoft-Cognitive-Service-AI-to-BI

Microsoft Cognitive Service – AI to BI

Artificial Intelligence (AI) is a way of making nonliving objects to think and react like a human and Machine Learning (ML) is a part of AI and Microsoft Cognitive Services is build using ML. What is Microsoft Cognitive Services? Microsoft Cognitive Services are a set of APIs, SDKs and services available to developers to make their applications more intelligent, engaging and discoverable. It helps developers to create the next generation of applications with the ability to understand, interpret, see, hear and [...]

nodejs

Node.Js all you want to know

Now a days, whenever performance oriented web server debate are done then one name emerges out of other web server framework, that is Node.Js. So, in our mind question occurs that, why Node.Js and not JavaEE or .Net framework or any other. I have tried to identify about this question. My First question is “WHAT IS Node.JS?” It is a JavaScript run-time environment, developed on Google V8 JavaScript engine. It was originally written by Ryan Dahl in 2009. It is Open [...]

Data-integrity-and-software-validation

Data integrity and Computer Software Validation (CSV)

For any software implemented, regulatories in their audit look for adherence to regulatory and quality standards. These standards would include the following: GxP US FDA’s 21 CFR Part 11/EU Annex 11 (Electronic records and signatures) US FDA GMP (211.68) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product If such equipment is so used, [...]

Progressive Web App Development

Progressive Web App Development

PWA (Progressive web application) is a new way to design web application with the best of Mobile & Web. This app does not require any installation, it loads extremely quickly in distributed network, and quickly sends push notification. It has home screen icon with full screen experience. For browsers supporting “Service Worker”, “Web Push Notification” and “Add to Home Screen banner”; the PWA rocks and it provides native like experience to the user. In past many attempts were made for [...]