Ideagen
IDEA]

William Osler, one of the most significant influencers in medicine had said, “Medicine is a science of uncertainty and an art of probability.” Ever since in an effort to improve this probability, government bodies have been increasingly imposing various regulations onto the pharmaceutical industry, primarily to deal with the malpractices ranging from improper branding to masking safety information and disregarding quality manufacturing standards. At the moment, any violation of regulatory methods or non-compliance of standards could tarnish a company’s reputation, risking its future. Leading pharmaceutical companies have started to implement effective compliance management systems internally, while others have been struggling to adhere to the sea of regulatory changes. To help pharmaceutical companies of all sizes overcome this struggle of remaining compliant, Ideagen offers a range of solutions to relieve these burdens and to transform quality and risk management from a bureaucratic chore into a substantial efficiency benefit.

Ideagen takes a risk-based approach to quality and compliance management, giving clients the confidence and evidence on their products and services being safe and fit for purpose. Since its inception in 1992, the company has been a leading vendor of regulatory compliance software and systems, ensuring quality of the highest standards required by regulators.

Enabling Accountability and Steady Growth

Life Science companies must demonstrate a high level of quality and compliance with a number of international standards and regulations such as the FDA (including 21 CFR Part 11), ISO, US Department of Agriculture (USDA), and MHRA. Complying with these standards requires an effective regulatory compliance software solution to help manage all the compliance needs across the entire organization. Enter Q-Pulse, Ideagen’s quality management software that supports life science organizations worldwide to continuously stand up to regulatory scrutiny, allowing them to accelerate the time to market within the pharmaceutical, medical devices, or biotechnology markets.

Q-Pulse is a software product that has taken an evolutionary journey over three decades, incorporating the disciplines of quality, safety, and risk management to deliver compliance, brand protection, anticipation of problems, and high operating efficiency to thousands of organizations around the world. The solution helps life science organizations across the world to successfully meet and maintain their regulatory requirements.

Ideagen's solutions and services helps to increase efficiency and productivity, reduce costs, and gain valuable insi ght into how the compliance processes that take place across the organization could be improved

Ideagen’s solutions and services help to increase efficiency and productivity, reduce costs, and gain valuable insight into how the compliance processes that take place across the organization could be improved. The Q-Pulse solution eliminates bureaucracy, automates, and streamlines business processes for standards and regulatory compliance, safety management, and risk management.

Ideagen’s customers include many clinical laboratories that use Q-Pulse to manage quality, compliance, and safety. In addition to having the option to be installed on-premise or hosted remotely, Q-Pulse can be customized and integrated with a business’ line of business (LOB) systems and can be configured to deliver the solution that maximizes their overall operational and business benefits. The solution fosters an open reporting culture that generates timely business intelligence, improves decision-making, and enables a rapid response to emerging problems. Furthermore, it helps clients in demonstrating compliance with any standards or regulations, reduce exposure to the risk of non-conformance, avoid fines, penalties, and reputational damage, and enjoy the peace of mind that comes with control.

"Ideagen takes a risk-based approach to quality and compliance management, giving clients the confidence and evidence on their products and services being safe and fit for purpose"

An Example of Excellence

A leading contract manufacturer of novel injectable formulations and devices for use in clinical trials, Symbiosis Pharmaceutical Services, wanted their electronic QMS to be validated to comply with FDA requirements. Although such a process can be a lengthy process taking up to six months, by turning to Ideagen for help, Symbiosis was able to use Ideagen’s validation documentation templates to carry out their entire validation process in just four weeks. Murray McKay, the Quality Director of Symbiosis Pharmaceutical Services says, “One element required for the audit was a validation of the system, which was a bit daunting but had to be done. We approached Ideagen to utilize their validation service, which comprised of some excellent support in terms of documentation and in the core IT system requirements and properties. This documentation included a Q-Pulse User Requirement Specification (URS) template, containing a list of all the Q-Pulse requirements by module, with a brief description of each.

As the end user, this enabled us to use this template to create a URS relevant to our use of Q-Pulse.”

Symbiosis was also provided with a Detailed Design Specification (DDS) template for Q-Pulse, which was used to create a DDS which reflected their use of Q-Pulse, a Computerized System Validation Plan (CSVP), a Computerized System Validation Report (CSVR), a configuration checklist and a Certificate of Conformance. As a result, Symbiosis was able to validate their system in 4-6 weeks, as opposed to 4-6 months. McKay added that Ideagen’s validation service was helpful as the Q-Pulse’s materials and templates helped the client reduce the time, effort, and pain in creating their documentation from scratch. With Ideagen’s help, the client was able to base their documentation set on the predefined templates and that greatly simplified the whole process of carrying out the validation. There is a lot of work to complete during the validation process, but Ideagen’s help meant that we could formulate that work and format it in a way that made it a lot simpler to work through the scripts that we had to qualify. After a successful implementation of Q-Pulse, McKay says, “Because we were doing the whole GMP system—and not just components of it—that was a significant piece of work. However, the support that we got from Ideagen helped save us a significant amount of time and resource. This all enabled us to easily develop a Validation Plan specific to our organization, helping us achieve compliance with key regulatory requirements.”

Building a Compliant Future

Headquartered in Nottingham, England, Ideagen enjoys a global presence through its operations in the United States, Europe, Middle East, and Southeast Asia. Today, it helps manufacturers, airlines, and healthcare organizations to control safety and risk, comply with standards and regulations, and achieve unprecedented levels of quality and efficiency. Ideagen enjoys a customer base of over 3,000 organizations using its suite of products, including many blue-chip brands such as Shell, BAE Systems, Emirates, and the European Central Bank as well as over 150 hospitals in the UK and the US combined.

With the latest release of Q-Pulse 6.6, Ideagen is helping aviation organizations to improve safety reporting by populating exports with the correct file needed to convert MORs to an ECCAIRS compatible format. What this means for their users is that they do not need to spend time searching for the correct files or effort in remembering where they are stored, making it more likely for the users to choose the correct file and cut the time it takes to submit reports to ECCAIRS.

In the fourth quarter of 2017, Ideagen has secured a $1.6 million contract win in North America following the successful deployment of Q-Pulse system across a global leader in the petrochemical industry, particularly across the Middle East. David Hornsby, the CEO of Ideagen, says, “We continue to see strong business demand for our software across all our key verticals. This contract demonstrates the strength of both our products and our ability to grow revenues from our extensive customer base.