If you operate in the healthcare or pharmaceutical industry, you’ve definitely encountered GxP guidelines before. GxP focuses on:

  1. Traceability – the ability to reconstruct the development history of a drug of medical device
  2. Accountability – the ability to resolve who has contributed what to the development of the product and when
  3. Data Integrity – the reliability of data generated by the system

However, the current heavily manual, document-driven processes makes it very difficult for organizations to ensure that these three principles are being accounted for. The development process in the healthcare and pharmaceutical industry has traditionally been Waterfall. The Waterfall development methodology is very rigid, does not account for change, and usually is extremely costly.

The fact of the matter is, Waterfall doesn’t match the reality of most development lifecycles – even in highly regulated industries like healthcare and pharma. It’s highly unlikely that all requirements are considered up front and/or don’t account change as development progresses. As a result, the occurrence of errors and gaps increase especially when the volume of information and frequency increases.

Learn More: How To Scale Agile While Managing Risk And Compliance

Change Is the New Normal in Product Development

When developing a complex software system, change is inevitable. Change comes from many different sources, such as:

Outside Change

New regulations, technology, and competition sets the stage for what changes can be expected by organizations. These changes are inevitable and are accelerating faster than ever before.

Internal Change

As companies grow, the old ways of designing and developing products clash and becomes quite burdensome. Legacy debt makes it difficult for organizations to adopt innovative practices and to deliver high-quality products faster.

Requirements Change

It is nearly impossible to define all requirements before starting any sort of development work. As projects progress, additional requirements are typically discovered – people need to visualize these requirements.

Design Change

Successfully designing user experiences requires iterative feedback from the end-user. The Waterfall methodology locks in the requirements long before the end-user gets to use the product, ultimately this results in lots of rework and wasted effort because once it’s done it’s extremely difficult to change.

It's clear that change is inevitable, and with the importance of software growing it's time for pharmaceutical and healthcare organizations to reconsider the "status quo". Changes in the industry is making traditional work methods obsolete, hence there is a significant opportunity for growth, which makes it critical to answer the following question: Is there a better way?

Addressing The Shortcomings Of Waterfall With Agile

Implementing agile in pharmaceutical and/or healthcare organizations can easily be compared to oil and water – they just don’t mix. However, we believe that this doesn’t have to be the case. The current waterfall approach being utilized results in not only product delivery delays, but it also heightens the risk of misconnected data and non-compliance. With customers and regulators expecting more, the time to rethink your relationship with waterfall is now!

Learn More: How Agile Helps Heavily Regulated Industry Handle Change

We get it – a total transformation into agile seems rather daunting. However, I strongly believe that agile does have a place in heavily regulated industries, like pharma and healthcare. It’s critical to consider the greatest challenges organizations like yours today face – product delivery delays, misinterpretation, non-compliance, etc. The main tenants of agile development focus directly on addressing some of the key challenges being face through principles like:

  1. Individuals and interactions over processes and tools
  2. Working software over comprehensive documentation
  3. Customer collaboration over contract negotiation
  4. Responding to change over following a plan

While they may seem extreme, these principles match the GxP guidelines that we mentioned earlier - traceability, accountability, and data integrity. Consider this: 

Individuals and interactions over processes and tools for organizations:

Operating under GxP guidelines would mean that previously siloed teams would have to work closely together, therefore the risk of misinterpretation and missed requirements is significantly reduced.

Working software over comprehensive documentation:

This doesn’t necessarily mean you have to get rid of documents, rather it suggests that business requirements documents and functional requirements documents are delivered to developers in a streamlined format. This means delivering the requirements in the forms of user stories, acceptance tests, and gherkin files. Not only will this reduce the risk of misinterpretation, but it will speed up product delivery while maintaining a high quality.

Customer collaboration over contract negotiation:

Let's be honest - missed requirements are a fact of life in a waterfall work environment. The end-user rarely gets what they had initially expected, and everyone is left frustrated and confused. However, because agile promotes collaboration with all relevant stakeholders, the end-user is not only considered but they're a part of the conversation! This reduces the risk of missed requirements, ensures the end-user is satisfied with the product, and everything is within budget. 

Responding to change over following a plan:

Agile encourages teams to work collaboratively and within short iterations. For organizations who are following GxP guidelines, this will help you be more organized in maintaining the endless paper trail, but it also ensures that products are being developed with greater attention to (regulatory) detail. 

Is Agile Suitable for a Heavily Regulated Environment?

When properly adapted to the guidelines of GxP, agile can be more successful than the current waterfall methods. Agile is designed to give iterative feedback throughout the course of product development. This process is well-suited to meet the requirements of GxP as it makes the development lifecycle significantly more transparent, precise, and efficient. The iterative feedback cycle will healthcare and pharmaceutical organizations to:

  • Adapt to change
  • Rapidly reduce requirements uncertainty
  • Increase development velocity and reduced wasted effort
  • Align the end-product with the needs and expectations of the user
  • Reduce the non-compliance risks and defects
  • Ensure products are compliant, and the process is always audit-ready

Learn More: Maintain traceability, accountability, and data integrity with Storyteller for GxP

Adopting the agile methodology gives organizations like yours the opportunity to successfully tackle the changing regulatory and technological landscape and ensure that the products you are delivering adhere to the highest quality standards.

Discover how with the right tools, your agile transformation can help you achieve GxP compliance in a streamlined and digitally innovative fashion, check out our latest video.

 

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