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.

Here are 5 key facts to help you learn more about training management and SCORM.

Fact #1: SCORM helps Training Management systems integrate with eLearning content

The SCORM standard was developed to ensure that eLearning content and Training Management systems work with each other, enabling you to increase the synergy between these systems. SCORM functions in a similar way to the DVD standard, which ensures that all DVDs will play in all DVD players regardless of the manufacturer. In a similar way, SCORM enables you to launch training content and capture training results, regardless of the content provider. According to Rustici Software, a provider of SCORM-compliant products, “SCORM tells programmers how to write their code so that it can play well with other eLearning software.”

Fact #2: SCORM is a widely-adopted standard for eLearning integration

SCORM is the most widely used adopted standard for page-turner courses. A page-turner course is just what it sounds like. This is an interface where the user navigates through eLearning or other content to move from one page/screen to the next. This can include video, Flash content, and even assessments. SCORM content also tracks the user’s performance, progress, and interaction with a course.

Fact #3: SCORM content can be purchased

Many organizations opt to purchase SCORM-compliant content to use within their eLearning systems. For certain topics, this may be more efficient than trying to develop the material in-house or sending people to off-site training. SCORM content is reusable so a wise purchase of this content can return your investment for years to come.

Consider purchasing training materials for broad compliance topics like GMP and ISO which are critical training areas but are not specific to your organization. Oftentimes, this results in higher quality content distributed more quickly than in-house training materials. ELearning providers such as SkillSoft, Harvard Business Publishing, and OpenSesame are all providers of SCORM-compliant course content.

Fact #4: You can also develop your own SCORM content

Despite the benefits of purchasing eLearning content, there are times when you may wish to develop your own. There are numerous SCORM authoring tools, such as Adobe Captivate or Lectora, that enable you to rapidly create eLearning content. Creating content in-house is a good option for training content that is highly specific to your business.

Fact #5: Your training management program can be SCORM-compliant

Bonus fact: When reading about SCORM, you may see the terms SCORM-compliant or SCORM-conformant. These phrases are interchangeable.

Pilgrim’s SmartSolve® Training Management software is SCORM-compliant. This means that Training Management enables trainees to launch SCORM-compliant eLearning courses directly from the system. Once the course is completed, our SCORM engine automatically updates the employee record with training completion status and results.

You can learn more about SmartSolve Training Management – including our SCORM capabilities – by watching our overview video below.

What are your e-learning plans for your trainees? Please share your ideas in the comments below.

 

Training Management Software

5-Minute Overview Video

SmartSolve® Training Management helps you manage training and certification for a qualified, competent workforce. Watch this short video to learn how Training Management can help your organization effectively.

Training Management and SCORM

 

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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Resources for FDA Compliant Change Management

Resources for FDA Compliant Change Management

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Like the corrective action process, the change management process is a central part of your quality management system. Change is difficult to manage because it touches every area of your business (including suppliers) because it is constant, and because the process to manage it needs to be compliance-driven. If you already have a change management process in place, here are some resources to help you understand areas where your process can be more harmonized, compliant, and efficient.

Tell the whole story about each change.

This Q&A on FDA compliant change management provides insight into better managing impact assessment and documentation of a change. These areas are typically weak in most change management processes. The article points out that change documentation is often weak or incomplete because there is an internal assumption that “everyone knows what is going on.” When an auditor or other third party later reviews the change, the record seems incomplete because it doesn’t tell the full story. This can make the process seem less thorough or compliant than it actually is.
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Get a Grip on your Data Integrity

Get a Grip on your Data Integrity

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, summit, or workshop event over the last two years, and you’ll notice Data Integrity has found its way into nearly every one.

If you listen carefully to attendees and others in the industry who are responsible every day for ensuring data integrity, you’ll hear how this very complex requirement creates a lot of anxiety among many companies when they examine their particular quality management processes. Their main objective is to avoid any observations by regulatory bodies resulting from data integrity issues. But why is it so complex?

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3D Printing Medical Devices: The New Frontier in Personalized Medicine and its Impact on Quality Compliance

3D Printing Medical Devices: The New Frontier in Personalized Medicine and its Impact on Quality Compliance

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 personalized medicine, where medical devices and even pharmaceuticals can be produced on demand, with specifications suited to a specific patient. For the Life Sciences industry, it means the potential to transform the way patients are treated, improving the efficacy of their treatment and their quality of life.
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MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

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

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
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Eliminate the Validation Bottleneck

Eliminate the Validation Bottleneck

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 LNS Research.

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ISO 13485:2016: Are you prepared for the transition?

ISO 13485:2016: Are you prepared for the transition?

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 takes effect in March 2019. Medical device manufacturers that aren’t prepared for this change will need to do some heavy lifting to stay compliant with the updated standards.

Do you know if you need to do light or heavy lifting to get ready for the new version of ISO 13485? Here is some insight on where to start when reviewing changes between the old and new standard.

Checkpoint 1: Has your organization kept pace with regulatory requirements?

If you’ve been keeping pace with evolving regulatory requirements, your organization will have a simpler path to ISO 13485:2016 compliance. It depends on whether your organization is aligned with internationally converging quality regulations and guidances, as well as the maturity of your existing quality system.
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