Regulatory Compliance Solutions Blog

Validation Packages

Friday June 2, 2017

The leading commercial business software now has a pre-packaged validation solution for the life sciences industries.

Licensed Product Support For Your Enterprise Software System

Wednesday May 24, 2017

When your enterprise software system is updated, do you have a reliable maintenance program that assists in assuring compliance?

How to Prepare for an FDA Audit by Using a 21 CFR Part 11 Assessment

Wednesday May 17, 2017

The FDA regulation in 21 CFR Part 11 applies to all types of research, clinical studies, maintenance, manufacturing, and distribution of medical products.

FDA Cybersecurity Guidance For Medical Devices

Friday July 29, 2016

In January 2016, the U.S. Food and Drug Administration (FDA) published a guidance draft that includes important steps that should be taken by medical device manufacturers in order to frequently address cybersecurity risks.

FDA Vaping Regulations In Full Effect as of August 8th 2016

Friday July 29, 2016

The FDA's regulations took effect on August 8th 2016.

Understanding SAP's 2017-2020 Outlook

Tuesday April 26, 2016

SAP released it's 5 year outlook. What does this mean for clients users? What do they need to know and look out for?

Common Compliance Mistakes

Tuesday March 22, 2016

Compliance management is a vital process within the pharmaceutical and life science industries. Here are some examples of common compliance mistakes in the pharmaceutical and life science industries.

Tips To Prepare For A FDA Inspection

Wednesday February 10, 2016

FDA inspections are one of many ways the FDA protects the public health. Here's how to prepare for one.

Quality Assurance vs Quality Control - What's the Difference?

Thursday December 17, 2015

The terms “quality assurance” and “quality control” are often used interchangeably, but what exactly is the difference?

Verification vs Validation - What's the Difference?

Wednesday December 2, 2015

The terms "verification" and "validation" are commonly used in software engineering, but the terms refer to two different types of analysis.

Medical Device Packaging Growth

Tuesday September 22, 2015

The Medical Device Packaging market is expected to grow 5.92% over 2013-2019. What does this mean for different industries/products?

How to Use the FDA UDI Database

Thursday September 17, 2015

The FDA launched the Global Unique Device Identification Database which provides a resource to report adverse effects of devices and hasten reactions to recalls. What does this mean and how is it used?

The Evolution of API Testing: Application and Healthcare Based Industries

Tuesday September 15, 2015

API testing is becoming more and more important, especially within the application and healthcare industries, but why do you need to be testing? How do you know when you need to be testing, what you need to be testing, and beyond that, how do you prioritize your testing needs?

QAD Chooses IBM for Cloud Service in Australia

Wednesday September 9, 2015

QAD has chosen IBM's Cloud Centre in Sydney, Australia to expand hosting options for QAD Cloud ERP customers. How will this benefit users that do business in Australia?

Software Testing and Quality Assurance Emphasis in New Areas

Thursday November 6, 2014

One of the top priorities of any corporate IT organization is always software testing and quality assurance. Shipping a product is one thing – making sure that it is free from bugs and other issues that could negatively affect the end user experience is something else altogether.

SAP Partners with Birst Inc.

Tuesday November 4, 2014

SAP, the European software giant, announced on October 9, 2014 its intention to team up with Birst, a cloud service provider for businesses intelligence (BI.) The goal of this partnership is to provide customers instant computer data, stored in the cloud via SAP's HANA cloud platform.

SAP SE Acquires Concur Technologies

Thursday October 9, 2014

SAP SE, the German enterprise software vendor, made the news on September 18th after they announced their plans to acquire Concur Technologies for a price tag of $8.3 billion, making this the biggest purchase SAP has ever made. Concur Technologies is considered a leading provider of expenses management and cloud-based travel solutions.

Oracle’s BlueKai Acquisition: What It Means

Thursday September 25, 2014

On July 22, 2014 Oracle announced their new Oracle Data Cloud service. The most significant piece of this service came with their February 2014 acquisition of BlueKai for between $350 and $400 million.

Building an Effective Compliance Strategy

Tuesday September 23, 2014

Running a business entails handling everything from developing products, creating sales strategies, employee training and handling customer/client service requests. Because there are so many things on which to focus, some businesses overlook the need for an effective compliance strategy.

Third Party Logistics (3PL) Providers: What You Need to Know

Thursday July 24, 2014

Pharmaceutical companies rely heavily on third party logistics providers as critical components of their supply chain. With the pharmaceutical industry being one of the most strictly regulated industries globally, 3PL providers must adhere to applicable guidelines established by government and state agencies to ensure pharmaceutical manufacturers that they are in compliance with these regulations.