Cloud Posts

Validated Cloud Solution… absolutely!

Validated Cloud Solution… absolutely!

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

Life Sciences organizations are progressively searching and shifting to cloud-hosted environments to increase efficiency and reduce costs. But to do so, those organizations must be able to select a cloud service provider that helps to assure the confidentiality, integrity, and availability of data stored in the cloud.

Cloud-hosted environments help Life Sciences organizations with validation challenges and ease the process of qualifying cloud infrastructure with emerging capabilities and tools. In addition to the methods and controls to support the achievement of continuous quality and regulatory compliance, these organizations are seeking ways to maintain their Quality Management Systems (QMS) in a secured and validated state.
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Deploying QMS – Have it Your Way Now and in the Future

Deploying QMS – Have it Your Way Now and in the Future

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Can you predict, with certainty, how your company’s management and IT services will choose to evolve its business and its quality management solution model over the next few years? How about over the next decade? Unless you’re a soothsayer, it would be wise to adopt a platform solution today with enough flexibility to meet whatever needs and whatever challenges tomorrow may bring.
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The Case for Cloud: Why Regulated Industries Should Pay Attention!

The Case for Cloud: Why Regulated Industries Should Pay Attention!

Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions

Cloud computing can be loosely defined as the process by which a set of data resources are housed somewhere remote and are accessed using the Internet. Traditionally, these resources have been housed inside the data owner’s own office building behind a firewall, providing very limited or no access from the outside, and thereby, protecting these resources from outside intrusion. But the pendulum is swinging again. Forty years ago it was in the form of time-share computing. Today, in the global marketplace, an increasing number of organizations are opting to move to the Cloud – which in many respects is today’s time-share computing environment, only faster, cheaper, highly secure, reliable, and more accessible.
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Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Larry Ferrere, Senior Vice President, Product Strategy & Chief Marketing Officer, Pilgrim Quality Solutions

It’s time to make the move to the cloud. Most businesses are taking advantage of cloud-based applications, private clouds, or cloud data storage on some level. In recent years, the cloud has surged in popularity, and many business are making the move. Early adapters and small businesses view the cloud as a way to reduce IT infrastructure and resource costs, and also as a way of gaining access to technologies that might normally be reserved for larger companies.

Today, businesses are realizing increased benefits from cloud-based technologies beyond just cost savings. For the Pharmaceutical industry, many of the challenges that quality and compliance teams currently face can be simplified by deploying a quality system in the cloud. Let’s take a look at how a cloud-based quality system can propel your compliance efforts to the next level.
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Identity and Access Management in Quality and Compliance

Identity and Access Management in Quality and Compliance

Stanley Curtis, CTO and Senior Vice President, Software Engineering, Pilgrim Quality Solutions

Identity and Access Management (IAM) has become a necessary part of enterprise IT and the security infrastructure of an organization. While mostly driven by security concerns, IAM also makes life simpler for the end user of enterprise applications. This is particularly true in today’s world of tight integration between disparate enterprise software and the continuing increase in the adoption of ‘Best of Breed’ SaaS applications. (more…)

5 Speed Bumps You Must Negotiate on the Road to Rapid EQMS Deployment

5 Speed Bumps You Must Negotiate on the Road to Rapid EQMS Deployment

Rob Harrison, Research Analyst, LNS Research

When an organization has determined a quality process improvement imperative and resolved to take a time-sensitive course of action by harnessing technology in the form of EQMS, there are critical elements that must be considered to ensure success. These elements relate specifically to meeting the timeline demands while guaranteeing the solution delivers the correct functionality in a secure and responsive manner without compromising user adoption and potential for improvement and expansion. (more…)

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

Mark Crawford

Sometimes the most important step in a successful product launch is knowing where the documents are—getting delayed by not being able to find the documents the FDA insists on seeing (or worse, having to start over) is a major drag.  The same is true when it comes time for an FDA audit. (more…)