Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of security a… Read More

Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions In the era of applications that are either web-based or have some connection to web-ba… Read More

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than two years away… Read More

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product… Read More

Kevin Lee, Industry Solutions Manager, Pilgrim Quality Solutions On a day-to-day basis, most of us are busy taking care of the details. We’re fixing problems as they happen, checking t… Read More

Regina Brimmer, Customer Success Manager, Pilgrim Quality Solutions Most Fridays, this is a B2B blog focused on strategies for Quality and Compliance management. But just this once, you&rsqu&hell…Read More

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality SolutionsFollow @Roxane_Pilgrim Last week we hosted a webinar titled “Complaint Management Beyond Your Four Walls.” Durin… Read More

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical… Read More

Bernard Jee, Product Manager, Pilgrim Quality Solutions Nobody likes to hear complaints. When we do, our basic human instinct is to withdraw into our shell and stop listening. Unfortunately… Read More

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality SolutionsFollow @Roxane_Pilgrim Recently, Pilgrim co-sponsored a webinar with LNS Research titled “Supercharge Supplier Quality… Read More

Massimo Franza, Senior Director of Software Engineering, Pilgrim Quality Solutions Think about your quality system. When you initially automate a quality process, you begin by determining th… Read More

Rick Lowrey, CEO, Pilgrim Quality Solutions In recent posts, we’ve dug into the need to transform your quality management system and even how to extend quality management processes out… Read More

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions Let’s face it, the arms of regulators are getting longer and so is their vision. The exten… Read More

A new year has begun. For most of us that means a fresh start and a brand new set of goals. But have you set your quality and compliance goals and resolutions for 2017? Whether you’re… Read More

It has been our pleasure this year to share with you our perspectives on the latest topics in the Quality & Compliance industry. We wish you a delightful holiday season and a prosperous… Read More

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a… Read More

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions Within regulated environments, such as the Life Sciences community, there are a number of top-of-mind business chall… Read More

Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions Every regulated organization understands the need to implement a quality system. In fact, it’s a “… Read More

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions Regulators around the world commonly assess product design to ensure safety and efficacy in medica… Read More

Deb Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions Earlier this week, we hosted a webinar titled “ISO 13485:2016 – Will Your Transition Be a Marathon or a… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality SolutionsFollow @Roxane_Pilgrim Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry rig… Read More

Kari Miller, VP of Regulatory and Product Management, Pilgrim Quality Solutions Recently, Pilgrim was a sponsor and a presenter at the American Medical Device Summit. The conference examined… Read More

Lesa-Marie Mullen, Senior Legal Counsel, Pilgrim Quality Solutions Maybe it’s a budget deadline. A price expiring. An important project timeline. The vendor is selected, the lawyers ha… Read More

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions We witness the impact of Change Control every day, in the most mundane places. For instance, take a trip down the gr… Read More

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions This week, Pilgrim is officially introducing a new fully-validated solution called SmartSolve® Out Of Specification Ma… Read More

Justin Smith, Manager of Product Management, Pilgrim Quality Solutions Do you know the facts about SCORM? SCORM stands for Shareable Content Object Reference Model. SCORM is a technical stan… Read More

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions This is the story of a beautiful family – Mr. & Mrs. Quality Management and their two childre… Read More

Adonna Blasko, Marketing Manager, Pilgrim Quality SolutionsFollow @Adonna_Pilgrim What do inclement weather and FDA inspection results have in common? Whether you want to believe it or no… Read More

Stanley Curtis, CTO and Senior Vice President, Software Engineering, Pilgrim Quality Solutions It’s time to put down your pen and paper. Stop hoarding the mounds of paper artifacts tha… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality SolutionsFollow @Roxane_Pilgrim Like the corrective action process, the change management process is a central part of your quality manag… Read More

Christoph Knez, Sr. Account Executive, Pilgrim EMEA Data Integrity is one of today’s hot topics in the Life Sciences industry. Look at the agenda of just about any industry conference… Read More

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions 3D printing or Additive Manufacturing is the new frontier in the Life Sciences industry and person… Read More

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop s… Read More

LNS Research recently published a great blog post on the State of the Market for Software Validation in Life Sciences. Click here to read the full post from Dan Jacob, Research Analyst at LN… Read More

Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions How much effort will it take to get your organization ready for ISO 13485:2016? The new quality system requirement… Read More

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 secur… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality SolutionsFollow @Roxane_Pilgrim It’s an often cited statistic. Inadequate corrective and preventive action (CAPA) processes are sti… Read More

Justin L. Smith, Manager of Product Management Let’s talk about the elephant in the room. There is an ancient eastern parable that tells the story of several men and an elephant in a d… Read More

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions The definition of Quality is widely accepted as the achievement of customer expectations through c… Read More

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions Can you capture or even approximate the cost of quality defects? Is it possible to put a price on a true or potential prod… Read More

Adonna Blasko, Marketing Manager, Pilgrim Quality SolutionsFollow @Adonna_Pilgrim Only so much fits into a 40-hour work week. Pressing deadlines, critical projects, and a growing list of… Read More

Leo Barcenas, Sr. Software Engineer, Pilgrim Quality Solutions Last month we published the Basics of Federated Single Sign-On (FedSSO). This article will discuss Single Sign-On for federated… Read More

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions What is I18N L10N? Secret code? Part of an algebraic equation? A chemical compound? No, it’s not… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality SolutionsFollow @Roxane_Pilgrim Develop and maintain a compliant CAPA Process with these key ideas. The Corrective and Preventive Action… Read More

Kumud Bhattarai, Software Development Manager, Pilgrim Quality Solutions What is Federated Single Sign-On (SSO), and why does it matter? Guest blogger Kumud Bhattarai explains the basics bel… Read More

Adonna Blasko, Marketing Manager, Pilgrim Quality SolutionsFollow @Adonna_Pilgrim Combination products bridge medical devices, pharmaceuticals, and biotech products. Each of these areas h… Read More

Rick Lowrey, CEO, Pilgrim Quality Solutions “The most successful customer conferences are contingent on active customer participation and Pilgrim team collaboration.” #PilgrimFus… Read More

Massimo Franza, Senior Director of Software Development, Pilgrim Quality Solutions As my colleague Kevin Lee says in his blog, The Pursuit of Zero Waste: Continuous Improvement to… Read More

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions Time waits for no one. No one is more aware of this than companies that cater to the world’s grow… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how t… Read More

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions It takes a substantial amount of planning and effort to carry out an internal audit, but the outcomes can improve your processes… Read More

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions Quality Challenges Create Waste In a perfect world, all products are designed and manufactured to 100% of their design spe… Read More

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions Do people ever tell you that you’re a control freak? That’s not typically a compliment, unless you work… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions Think about your next FDA inspection. How will you feel when the inspection arrives at your facility? Will you be rushed or c… Read More

Dan Jacob, Research Analyst, LNS Research Manufacturers have historically struggled to generate meaningful Quality Management Analytics. With the advent of the Industrial Internet of Things… Read More

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions Complaints can come from anywhere; it’s what you do with them that matters. And when it comes to reportable events, time is… Read More

Matthew Littlefield, President & Principal Analyst, LNS Research There is a lot of hype when it comes to Industrial Internet of Things (IIoT) and Big Data Analytics. Many executives toda… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you… Read More

Matthew Littlefield, President & Principal Analyst, LNS Research This article is part 2 of a 2-part supplier quality management series. The first article can be found here. As was stated… Read More

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions Take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Impr… Read More

Matthew Littlefield, President and Principal Analyst, LNS Research The demands on quality organizations are rising across the board, but perhaps none as quickly or urgently as in the life sc… Read More

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions When it comes to keeping your ears tuned to the latest industry news, there are so many resources and voices vying for your attent… Read More

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions Congratulations! You’re being audited by the FDA! If you’re doing business within the United States, you may find your… Read More

Konyika Nealy, Sr. Director of Quality Assurance, Pilgrim Software  Are radical changes coming? Is this fifth incarnation of ISO 9001 a drastic departure from its predecessor? Will it r… Read More

Matthew Littlefield, President and Principal Analyst, LNS Research With pressures to drive down costs while improving innovation and the safety of products, life sciences companies need clos… Read More

Kari Miller, Sr. Director of Industry Solutions & Product Management A culture of quality requires teamwork.  Teamwork is the natural result of working in an environment where peopl… Read More

Kari Miller Senior Director of Industry Solutions and Product Management Pilgrim Software, Inc. Vision, values, goals and strategy are the guiding principles of a corporation and culture cul… Read More