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 [...]

Microsoft Dynamics AX

Account Payable Business Process in Microsoft Dynamics AX

In this blog we are explaining the basics of the account payable, configuration and which module integrates with the account payable. Account payable manages purchase order, vendor account, purchase invoice, purchase packing slip, vendor invoice, Payment Journal, and Return Purchase order etc Account payable provides the settlement functionality; in this functionality you can settle invoices with payment. (more…)

What is SSIS? Its advantages and disadvantages

What is SSIS? Its advantages and disadvantages

SSIS stands for “SQL Server Integration Services”, Microsoft have their many products to compete different segment. To compete in segment of data migration, ETL and transformation, Microsoft had introduced their tool with SQL 2005. Microsoft empowers it with all the ammunition to help data migration, transformation, ETL and other function. According to me it is not a tool but a platform which empower user to do ETL (extract, transform, and load) operations, performing complex solution such like email to [...]