How to Prepare for FDA Submissions and Communicate Them With the FDA

A medical device company making a submission to the FDA on any of these: INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, and Post-Approval Supplements; needs practice and learning of all the intricate aspects of these activities. The FDA approval is necessary to start legal manufacturing a medical device or a combination product in the US. […]

Ten-Step Process for COTS Risk-Based Computer System Validation

SaaS, short for Software as a Service, is a method by which applications are delivered over the Internet. Also called on-demand software, hosted software, or web-based software; SaaS removes the need to install and maintain software, all which can be done with just an Internet connection. SaaS applications can be run on the provider’s servers. […]

What are the basic steps for implementing a project using Project Management methodology?

Sound project management lies at the heart of any work in organizations in any industry. This is because most work that gets done in organizations are projects in one or another sense. Any work, minor or major, works like projects, and take the same route in which projects are created and completed. This is why […]

How to effectively write an SOP to ensure compliance

What is an SOP? In an organization, it is an operation-specific procedure that gives a thorough description of all the activities needed to carry out tasks that comply with industry-related regulations, State laws, and many a time, the methods the organization itself has prescribed for its business. Documentation is at the heart of a solid […]

Principles & Best Practices for Qualifying Cloud Infrastructure

Businesses that work in GxP-regulated industries need to validate their GxP computerized applications for carrying on their day-to-day operations. A reliable, qualified infrastructure provides control and regulatory compliance of these applications. A noncompliant IT Infrastructure leads to failure of an entire site, and can bring an entire geographic area to a halt till the compliance […]

Learn from surviving to thriving of a Quality Management System

An efficient and effective Quality Management System (QMS) lies at the heart of a medical device company. Why do so many companies struggle to establish and maintain an efficient and effective QMS? Simple: not only is an efficient and effective QMS necessary to establish quality of the products; it is a regulatory requirement. Regulatory agencies […]

Learning Management Systems for Pharmaceutical Companies

When it comes to organizing and streamlining learning, few tools can beat Learning Management Systems (LMS). An LMS in the pharma industry serves very important purposes in assuring and demonstrating that employees in the pharmaceutical organization schedule and undertake their training for any discipline as and when required in the light of the issuance of […]