How Software Provider Innovation Is Driving Change in QMS Validation

Important changes are taking place in the way many software providers develop their products, ones that have direct impacts on the validation process.

Waterfall development vs. Agile development

For many years, developers have used the “waterfall” model to create their software. This involves creating a fully developed version of the software before presenting it to customers or internal customer representatives for testing and feedback. Each step – plan, analyze, design, construct, test, deploy and maintain – is done one after the other, forming a waterfall visual.

Here, all user requirements are defined before anything is developed. A major drawback to the Waterfall model is that it is often impossible to know all user requirements at the outset of a software development project. Those that are identified often change during the months-long development cycle. Others do not become evident to users until the completed version is put before them. Developers … Read more...

Changing Roles in the QMS Cloud Validation Model

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With the shift comes a change in who performs what roles in the validation process. Let’s look at this new responsibility landscape.

Who plays what roles

Who does what in the Validation model can change when we move to the Cloud. The customer remains responsible for, on the front end, validation planning and user requirements, and on the back end, user acceptance testing and validation reporting.

The software provider can assume responsibility for system requirements, detailed design, system configuration and development, unit/integration testing and system testing. The cloud provider can now look after the technical architecture and IQ.

Change control – private cloud vs. public cloud

Life sciences companies can tap into a wealth of innovative software that is being developed at a rapid rate – but it comes at a … Read more...

QMS Validation: Changes in the Cloud

Many companies in various industries are turning to the Cloud Computing model to validate their Quality Management Systems. This shift brings with it many changes to the traditional on-premises approach. Let’s look at what has changed in the cloud…and what hasn’t.

A key element in any software validation process is the Installation Qualification (IQ). This is essentially a checklist to ensure all elements needed to effectively run the software are in place. Questions to be answered include whether the software was loaded correctly and whether there is enough memory. The Cloud model’s architecture introduces new elements that companies must be aware of, as these pertain to the validation process.

Regulatory expectations for cloud providers

The traditional and the Cloud architecture share the same basic structure. It consists of:

  • A development environment, where applications are created
  • A test environment, where the recently developed software is tested exhaustively to make sure it
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Regulatory Responsibilities in the Cloud

Core to the process of ensuring quality in products is the concept of validation. This is the process whereby manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their offerings.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was done and when, including elements such as designs, tests and test-script executions.

A new method for achieving this is gaining significant traction. Known as the Cloud model, it sees companies handing off various parts of the validation process to third-party (or Cloud) providers who, for a fee, handle them on their own information technology infrastructure.

Companies that move to the validation of their Quality Management System (QMS) to the Cloud are still responsible for meeting the same regulatory obligations as in traditional models. … Read more...

Success Factors for Moving Into the Cloud

Customers are moving their Quality Management Systems into the cloud for many reasons:

  • It is easier to finance, with expenses spread out over a number of years. Because your company is sharing computing resources with other people, the total cost is cheaper overall. The services component will be higher than if things are kept in-house, but expenses such as hardware purchasing/upgrading and employment of increasingly expensive talent to manage the computing resources will be taken off the corporate ledger.
  • It is faster to deploy. Business benefits are realized much quicker because internal processes, such as reviews, approvals, and the accompanying meetings and endless email chains that typically bog down implementations are no longer part of the equation.
  • It offers faster access to the latest and greatest software features. No longer does the customer need to keep up with newest developments in software and implement those they want. Cloud providers
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The Cloud – What is it?

As we’ve seen in previous posts, many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. To gain a full appreciation of this movement and to see how it can potentially benefit your organization, it’s important to know just what characterizes the Cloud model and what makes it unique.

Traditionally, companies have owned and operated their Quality Management System using their own resources – an in-house IT department and fully owned, on-premises computing resources. However, given the increasingly sophisticated nature of QMS software and the high cost of specialized talent capable of managing, maintaining and upgrading it, firms are adopting the Cloud model is becoming an appealing alternative.

The three players

The Cloud model features three main players: the customer, the software provider, and a middle level participant, the cloud provider. The provider’s function is to manage the infrastructure and all … Read more...

When QMS Validation Goes Wrong: FDA Consequences

Before U.S. manufacturers can begin selling their products, they must ensure, by law, that their wares meet an acceptable level of quality.  A key part of that process is the act of providing objective, documented evidence to the U.S. Food and Drug Administration (FDA) that their processes, equipment and computerized systems are checked and validated.

Failure to meet these requirements can result in consequences of varying degrees of severity, depending on the nature of the offense and an outfit’s history with the FDA. These include:

  • Recommendation – Important feedback provided to companies with a good FDA relationship. An issue is noted in an audit file with the expectation that it be addressed by the next audit.
  • 483 form – A formal notice sent to the head of a company’s Quality department, with a response due within 30 days. This a low-key public record similar to a misdemeanor.
  • Warning letter
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Documentation and Traceability: Ensuring Your Software is Doing What it Should

Software validation is at the heart of the Quality process. It’s the method by which manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their final products.

Traditional on-premise validation of a Quality Management System (QMS) typically utilizes a “V Model” workflow. The process begins on the top left, with the left side defining a series of required deliverables. Once these are mapped out, you can configure and develop the system. Finally, as illustrated on the right arm of the model, the system is tested, with these actions being traced back to the previous planning stages.

The model helps organizations answer key questions about the project, such as:

  • What are you trying to accomplish?
  • What are the roles?
  • What documents are you going to generate?
  • Who approves them?
  • What process will you follow to develop this
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Managing QMS Validation the Modern, Efficient Way

With every trip to our local pharmacy, grocery store or corner variety shop, we pass hundreds of products that have reached the shelves only after a lengthy process designed to ensure their quality.

It’s not something the everyday consumer thinks much about. But without this crucial element of the manufacturing process, we would never be able to trust the quality of the many products whose high standards we take for granted. It’s quite easy to envision the catastrophes that would result.

Core to the process of ensuring quality is the concept of validation. This is the process whereby pharmaceutical manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their medicines and medical devices.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was … Read more...

Four Reasons Why Life Sciences Organizations Are Moving Their QMS to the Cloud

Life sciences organizations, including pharmaceuticals, and medical device manufacturers, constantly look for ways to reduce risk, increase patient safety, and achieve operational excellence. To be successful in these three areas, pharmaceutical and medical device manufacturing companies need to have robust management systems in place. This is even more critical than in other industries where the breadth of regulatory requirements is not as vast.

Transforming their QMS to the cloud can help them achieve these strategic objectives. Along this digital transformation journey, software validation can be a challenge with varying degrees of intricacy across organizations. Causes can range from lack of experience and expertise to the complexity of internal and external stakeholders involved. Ultimately, no one wants to receive a 483 from the FDA due to noncompliance with 21 CFR 11, which will put an organization in a bind and ultimately impact patient safety.

As pharmaceuticals and medical device manufacturers look … Read more...