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USDM's Guide to 21 CFR Part 11

What is 21 CFR Part 11? briefly , it issues acceptable standards for electronic records required by the predicate rules for all times sciences companies.

Specifically, 21 CFR Part 11 says that if you select to use a computing system to take care of , create, or modify records required by the predicate rules, then you want to do certain things to regulate those records. If you select to use eSignatures, you want to suits the wants during this regulation.

 

The intent of Part 11 is to take care of accountability and traceability of your electronic records, including eSignatures. In part, it asks:

 

Is system access restricted to authorized individuals?

Are authority checks wont to make sure that only authorized individuals can access the system, electronically sign a record, alter a record, and perform an operation?

Do signed electronic records contain the name of the signer, date and time of the signature, and meaning of the signature (i.e., review, approval, responsibility, authorship, etc.)?

Does the system provide transaction safeguards to stop unauthorized use of passwords and/or identification codes?

Can the system immediately and urgently detect and report attempts of unauthorized use to the system security unit and organizational management?

Are audit trails built into the system?

USDM Life Sciences has an in depth process and thorough checklist to make sure that you simply follow the guidance accurately. Contact us for your Part 11 needs.

 

Audit Trails

Every company will undergo audits, but there's more to them than simply meeting FDA regulations. Audits should drive best practices in your business processes and ensure that you simply are following applicable regulations designed to enhance product quality and ensure patient safety.

 

An audit trail consists of records that show who has accessed a computing system , when it had been accessed, and what operations were performed. Records or information entered into a top quality Management System (QMS) have specific requirements for tracking and traceability, and nobody should be able edit the knowledge without traceability or overwrite the knowledge . Altered records have requirements to understand who edited the records and for what reason. All created, modified, or deleted records must be retained and traceable to the user responsible with a timestamp and version history in order that previous versions are often viewed. Event logs aren't enough to satisfy the requirements of 21 CFR Part 11, unless they display the specified information.

 

21 CFR Part 11 Guidelines for eSignatures

eSignatures on controlled records are accepted a bit like handwritten signatures if they meet FDA requirements. eSignatures can't be copied from other parts of the document. the subsequent requirements pertain to system management and therefore the storage of eSignatures.

 

Ensure that your eSignature software is installed correctly, operates correctly, and performs needless to say .

Confirm data integrity and password security. System access must be secured by unique login credentials for every user. User interaction together with your data and modifications to your data must be recorded and traceable to stop unidentified interactions, fraud, security breaches, or non-compliant interactions.

Train employees to know their roles. Your system security is merely as strong as its weakest link. System users must be trained to suits the controls placed on the system, especially when it involves protecting data integrity and password storage. Train your employees on your systems and applications and cling to the training requirements and need them to certify that they understand that their electronic signature is that the legally binding equivalent of their handwritten signature.

Hiring an outdoor firm to assist you assess your QMS gaps and train employees can prevent time and money. Contact USDM to start out your regulatory assessment or to fast-track your compliant eSignature capabilities.

What is SCORM?

SCORM defines a specific way of constructing Learning Management Systems (LMSs) and training content so that they work well with other SCORM conformant systems.

 

What does SCORM stand for?

SCORM stands for “Sharable Content Object Reference Model”.

 

“Sharable Content Object” indicates that SCORM is all about creating units of online training material that can be shared across systems. SCORM defines how to create “sharable content objects” or “SCOs” that can be reused in different systems and contexts.

 

“Reference Model” reflects the fact that SCORM isn’t actually a standard. ADL didn’t write SCORM from the ground up. Instead, they noticed that the industry already had many standards that solved part of the problem. SCORM simply references these existing standards and tells developers how to properly use them together.

 

What’s a SCO?

A Sharable Content Object (SCO) is the most granular piece of training in a SCORM world. Some would call it a module, a chapter, a page… the point is that it varies wildly. A SCORM purist would tell you that it should be the smallest piece of content that is both reusable and independent. In terms of how the LMS treats it, this is the item shown separately in the table of contents and tracked separately from other items. It can contain its own bookmark, score and completion status.

 

How does SCORM work?

Basically, the different versions of SCORM all govern the same two things: packaging content and exchanging data at Run-Time.

 

Packaging content or the content aggregation model (CAM) determines how a piece of content should be delivered in a physical sense. At the core of scorm lms packaging is a document titled the “imsmanifest”. This file contains every piece of information required by the LMS to import and launch content without human intervention. This manifest file contains XML that describes the structure of a course both from a learner’s perspective and from a physical file system perspective. Questions like, “Which document should be launched?” and “What is the name of this content?” are answered by this document.

Run-Time communication, or data exchange, specifies how the content ”talks” to the LMS while the content is actually playing. This is the part of the equation we describe as delivery and tracking. There are two major components to this communication. First, the content has to “find” the LMS. Once the content has found it, it can then communicate through a series of “get” and “set” calls and an associated vocabulary. Conceptually, these are things like “request the learner’s name” and “tell the LMS that the learner scored 95% on this test.” Based on the available SCORM vocabulary, many rich interactive experiences can be communicated to the LMS.

Why use SCORM?

SCORM is a really powerful tool for anyone involved in online, computer based training, distance learning or eLearning. Content can be created one time and used in many different systems and situations without modification. This plug-and-play functionality can be powerful within an organization but even more so across organizations. Content can be sold and delivered to the user more quickly, more robustly and at a lower price.

 

SCORM is widely adopted by some huge organizations. It has the critical momentum and is the de facto industry standard. The US Department of Defense in DoDI 1322.26 has specified that all of its content must be delivered via SCORM or the Experience API (xAPI). All of it. Industry is following suit, and the standard appears in a vast majority of RFPs to procure both training content and Learning Management Systems.

 

Which version of SCORM is relevant?

The answer is all of them. The primary goal of adopting SCORM is to create an interoperable system that will work well with other systems. Support for all of the SCORM versions and AICC is essential to fulfilling that goal. To date, there are three released versions of SCORM, each building on top of the prior one.

 

SCORM 1.1 was essentially the first pass, and never gained wide acceptance. Some products still support it, but it is not widely adopted.

SCORM 1.2 followed on 1.1, and solved many of 1.1’s problems. It was and is the widely adopted version. Every major LMS continues to support it and the majority of content vendors still produce content that meets the 1.2 specification.

SCORM 2004 (formerly known as SCORM 1.3) is the most recent release. It extends and formalizes the packaging and Run-Time portions of the 1.2 standard, but its key addition is the sequencing and navigation (S&N) specification. S&N allows the content vendor to specify both the behavior within the SCO and the behavior between the SCOs. This allows for substantially richer content interactions and huge increases in the reuse of SCOs. Adoption has been slow, to this point, but the number of LMS’s and content vendors supporting SCORM 2004 is increasing greatly.

For more detail on the versions of SCORM, including the various flavors of SCORM 2004, visit the eLearning Standards Roadmap.

 

How does SCORM relate to AICC, xAPI and cmi5?

SCORM is a reference model, which means that it is built on top of existing specifications. From the beginning, SCORM has been described as a “best of breed” solution, culling the best pieces of prior specifications.

 

AICC, a standard from the aviation industry, was used as a basis for the Run-Time communication portion of the SCORM specification. Conforming to one standard does not mean that you automatically conform to the other.

 

xAPI, also referred to as the Experience API or Tin Can API,  is often considered the “next generation of SCORM” and is newest eLearning standard. At Rustici Software, we worked closely with ADL on Project Tin Can (the beginnings of xAPI), imparting our decade of SCORM knowledge to make sure that xAPI is a huge leap forward for the eLearning community. xAPI is vastly different than SCORM and provides a more flexible way to track a wide variety of learning, including activities that occur outside of the LMS. You can learn more about xAPI here.

 

cmi5 is an xAPI profile used when xAPI activities are launched from an LMS. cmi5 defines the necessary components for system interoperability such as packaging, launch, credential handshake and consistent information model. You can learn more about cmi5 here.

 

How can I make my system or content become SCORM conformant?

Check out the resources and articles on this site. They provide a good introduction to the technical nuts and bolts of SCORM conformance.

 

Achieving basic SCORM conformance for your content can often be accomplished by a talented software developer in a reasonable time frame. The hard part is creating content that is not only conformant, but also broadly compatible. Many LMS implementations have slightly different interpretations of the specifications and other quirks that can make seamless interoperability a challenge. If you plan to distribute your content broadly, or simply want to avoid the hassle of learning the intricacies of SCORM, check out our SCORM Driver (or Rustici Driver). It is by far the easiest way to create widely compatible SCORM conformant content.

 

LMS conformance is a much more involved project. The effort required to fully implement all of the specifications properly is usually measured in man-years and broad compatibility is even more elusive than it is on the content side. SCORM intentionally places the “burden of complexity” on the LMS. If you need make your LMS SCORM conformant, you should strongly consider using our SCORM Engine (or Rustic Engine). It is guaranteed to make your life a lot easier!

The Fallacy of Performance Reviews

Every year the dance begins. Supervisors and managers know they'll soon need to do the annual performance review for all of their employees. They get the notice from HR reminding them of the deadlines. They get copies of the forms which will be used. they'll even get some training on the way to use the forms or conduct the reviews more effectively. Every few years the method will change - either during a small administrative way or in some more substantial way - a minimum of from the attitude of these revising the method.

 

But to the supervisor, it's all an equivalent . Once a year they need to possess a performance conversation with their "direct reports."

 

While the worker doesn't get the memo from HR, they know the time is coming too - they know that at some point they'll get an email from their boss, or the subject will come up during a staff meeting. "Performance Reviews are going to be soon, check out your calendars and let's find a time to try to to this."

 

Most supervisors make this proclamation with a significant tone - they know that they represent the organization's interests, which albeit they do not like doing these reviews, they know they're a neighborhood of the work . Most employees with quite a few of years on the work know what their bosses are thinking also - and therefore the dance continues.

 

And so it goes - supervisors do performance reviews because they're expected to. And employees participate because they need to . Far too infrequently does this conversation cause meaningful changes in performance - either taking a high performer and making him or her a star or taking an individual with some performance challenges and helping to form significant strides of improvement.

 

Of course these are the goals of the performance review - to supply people with feedback on performance, compare that to the expectations of the work and supply a chance for conversation on the way to improve (regardless of the present level of performance).

 

These goals are wonderful. Unfortunately, in most all cases, a performance review, regardless of how well done, regardless of the intentions of the participants or the skill of the supervisor, won't achieve these goals.

 

In other words we do the performance review in our organizations because these goals are valid and "everyone does them." Then once they don't reap the specified results, organizations look to update the forms, improve the feedback skills of the supervisors or otherwise improve the method .

 

Here is that the best thanks to improve the process: Eliminate the Performance Review.

 

That's right, I said get obviate performance reviews!

 

The Fallacies of the Performance Review

 

Imagine that a dancer had a private coach. That dancer would expect their coach to supply them with a transparent picture of what excellent performance seemed like , expect ongoing encouragement, regeneration when appropriate and correction when needed. The dancer wouldn't be very happy if the coach only watched once in awhile throughout the year during occasional performances or practices, then scheduled an annual meeting to debate progress.

 

In the same way, a golfer would need a coach to supply feedback frequently and timely.

 

We read these examples and nod our heads in agreement. Then we attend work and do precisely the opposite.

 

In the most fundamental ways our work is not any different from the dancer or golfer - in our work we perform (do our work) all the time. so as for us to profit from coaching it must be in context, and within the flow of our work. Unfortunately the performance review process is about up to seem at our work as a snapshot, instead of a running video.

 

Stated simply, while performance is an ongoing process, a performance review is an occasion (and usually a far too infrequent event at that).

 

What you'll do as a pacesetter

 

There are several belongings you can do as a pacesetter to figure within your current performance review process and still make it work significantly better. Everything suggested is within your control and won't violate any of the tenets of your existing organizational process.

 

1. Stop thinking of the annual event. Yes, you'll need to do the forms annually, but you'll meet and discuss performance as often as you would like.

 

2. Turn it into a process. Regular conversation, perhaps informal, will bring a way better outcome.

 

3. Remember the key purposes. Clear expectations, discussion of progress and feedback for continual improvement. These three guideposts will make your conversations more useful to each one.

 

4. Explain the change. Let your people know what you're doing and why. Once they know why you're doing this, they likely will love it!

 

5. Improve your skills. Yes, you'll recover at giving feedback, building rapport and every one those things (we all can!). And once you are having regular conversations you'll recover faster!

 

6. Use your review process as a culmination. you'll fill out the forms and paperwork anytime. And if you're having ongoing conversation, it should be quite simple!

 

What you'll do as an Employee

 

As an employee you'll be thinking that, while you accept as true with everything you've read, there's really nothing you'll do to vary your situation. While you do not hold all the cards during this game, you'll be proactive in posing for more of a process approach.

 

1. Invite a clearer picture of success. it's your success you would like to make - it's only appropriate that you simply know exactly what's expected.

 

2. Invite feedback regularly. albeit it's very informal or if your boss doesn't recognize this as "reviewing your performance," you'll create something that's more like an ongoing process, and fewer like an annual event.

3. Share successes and challenges regularly. this may assist you get the feedback you would like to still improve.

Final Thoughts

People often inquire from me , "How can we improve performance reviews?" I surprise many of us by saying "The neatest thing you'll do is eliminate them." Hopefully this text explains why I feel this manner . I do recognize that a lot of aren't within the position to eliminate them completely, then my secondary advice is to require the main target off of the annual review and put it back on performance. Since performance is ongoing, so should the conversation about it.

Turn your review event into an ongoing conversation and you'll have taken the foremost important step you'll in making your process relevant and useful to everyone.