September 2016 Posts

Insights on Out of Specification Management and Compliance

Insights on Out of Specification Management and Compliance

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

This week, Pilgrim is officially introducing a new fully-validated solution called SmartSolve® Out Of Specification Management. Managing out-of-specification (OOS) results is a critical area of focus among pharmaceutical and combination product manufacturers. To help you understand the critical nature of this operational element, we’ve created this Q&A about compliance facts and insights on data integrity, and commonly used acronyms that relate to OOS. Let’s begin with the basics. (more…)

Training Management and SCORM: 5 Facts You Need to Know

Training Management and SCORM: 5 Facts You Need to Know

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 standard, but that doesn’t mean you should dismiss it as something to be handled by your IT staff. If you’re involved in employee training and competency, you should be aware of SCORM and some of its potential benefits to your training management program. (more…)

Document and Change Management: These Siblings Play Well Together

Document and Change Management: These Siblings Play Well Together

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

This is the story of a beautiful family – Mr. & Mrs. Quality Management and their two children, Document Management and Change Management. Unlike many siblings that squabble daily, the Quality family kids play very well together. Their favorite playground is in the Life Sciences where they frequently collaborate to show off their teamwork and agility.

In that arena, the siblings do sometimes demonstrate distinctive personality traits as well. For instance, Document can be overwhelming, and at times, sloppy and out of control; Change is a constant force and can be difficult at times, but prefers to be in control. In those instances, they need to support each other. There’s no denying their relationship, and that they are, in fact, better together. (more…)

FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?

FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

What do inclement weather and FDA inspection results have in common? Whether you want to believe it or not, they can both escalate from serious to disastrous fairly quickly. For anyone who’s spent significant time in the Midwest or tornado alley, it’s common knowledge that a tornado warning is more serious than a tornado watch. The truth is, the tornado alert system has quite a bit in common with FDA inspections, FDA Warning letters, and FDA form 483s. Let’s take a closer look.

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Using Automation for Software Validation

Using Automation for Software Validation

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 that result from manual Computer System Validation (CSV). Free up your valuable resources for other operational tasks while safeguarding the results of your CSV. All of this is possible with automated and paperless validation tools for software validation.

The FDA requires computer systems validation for any software-driven components built into medical devices, or software used to design, build, or manufacture medical devices. The same holds true for software used in the manufacturing of pharmaceuticals, biologics, or other products or components for Life Sciences. Amazingly, some companies—large and small—still perform validation manually.
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