Pharmaceutical companies are in a hurry to adopt agile software development practices. It’s a massive trend seeing companies forcing teams to climb the agile train. Alas, agile transformation is hard and takes time. And mastering agile practices that are GXP compliant is ten times harder. This leaves many teams in an organizational inflicted chaos and confusion. They cannot metamorphose overnight. But, all hope is not lost. For pharma, a generous dose of DevOps is the secret sauce for agile transformation success.
It may sound crazy to take on board two initiatives at once, but let me explain. We’ll have a close look at why agile is so hard and how DevOps helps.
Agile and the less-documentation mantra
Reaping gains from Agile is not quick for any team. I can buy the best running gear in the world, but putting on the best running shoes does not make me sprint like Usain Bolt. Or even not like my neighbour who was hard in practice for the last three years. In the same way, a team that moved to Jira Software will achieve high release cadence immediately. Growing muscles and capabilities takes time.
This is even harder for teams in pharma. They cannot adopt agile practices that preach that documentation is not important. Teams are torn between the push to be agile, and the imperative to create compliant release documents. This struggle leads to an unfathomable amount of sweat and tears.
So it’s time to be honest and accept reality as it is. Between compliance and agility, compliance always wins. And agile is ok with this. A non-compliant product has zero business value. Agile prioritizes business value above anything else. Any agile transformation that does not embrace compliance is a false promise. A mirage.
But, reconciling agile with compliance requires a nuanced approach. And that’s always hard. It requires going beyond the common agile cookbook. This inherent difficulty is exasperated due to the revolt against documentation.
Let’s be honest. Over the years, the amount of documentation in pharma has bloated. Oftentimes, the easiest way to fix an audit finding is by adding more documentation. It’s rare to have a pruning process to remove documentation or simplify templates. Pharmaceutical companies tend to hoard templates. Teams are burdened with a massive amount of documentation. They hope that agile will unshackle them from all that burden. Management pushes for agile? Well, how can we when we need to create countless non-sensical documents?
Management’s eager pursuit of agile leads to unprecedented willingness to rationalize documentation.
And then there is DevOps.
DevOps can be the path to reconciling the two opposite pulls. DevOps adds to agile this extra muscle to deliver on everything that agile promises, and more.
Why DevOps is the magic enzyme for agile transformation
Compared to agile, DevOps is a more recent trend. But DevOps with agile is such a potent combination, that it will be a massive miss if pharma adopts them in two steps. DevOps helps resolve the most sticky point of all how to make agile work despite the need to create release documentation.
Here is why:
- DevOps puts the focus on frequent releases: This is the ultimate goal of going Agile in the first place. Somehow when teams think “agile transformation”, the fact that documentation is still required, causes severe disappointment and letdown. Going for a quick release cadence is an invigorating goal. It gives purpose to the agile effort. The need for documentation becomes a design imperative, rather than a barrier.
- DevOps helps create a flywheel effect. The thrive for frequent releases also helps deliver tangible business value quicker. And that is vital for any change management effort. The traditional pharma release cycle is very long (6 to 12 months). A skilled DevOps and agile roll-out can quickly achieve shorter release cycles. Reducing releases to three months cycles, and then six weeks cycles have a significant business impact. These early gains are energizing and help keep the momentum alive for longer. It triggers a flywheel effect that accelerates the whole digital transformation initiative.
- Automation helps reduce the documentation burden. While agile is a theory with a set of practices, DevOps emphasizes the use of tools. In pharma, DevOps tools ease the documentation burden by removing manual work. No, there still is no AI to decipher the specifications from the code, but all the rest can be automated. In a mature DevOps implementation, each team member creates the documentation bit by bit, in context. For example, a functional specification item is updated when grooming the story. The CI/CD cycle injects the test results into the traceability matrix. Tools generate most of the release documentation. The product manager adds a few sentences and sends them off for quick approval by stakeholders. And guess what: the process of automating all this documentation, sees a lot of the hoarding go away. Careful scrutiny removes everything that is not essential. Skilful effort removes the bloat.
What to do
Here are the steps to tackle your agile documentation problem:
- Review the list of required documents and reduce whatever you can. Do not try to achieve massive cleanup at this stage. Later stages will remove more waste.
- Map who creates what documentation snippet and when. Setup tools to make this an integral part of the agile flow.
- Automate the aggregation from documentation snippets to release documents.
- Iterate. An optimal documentation flow requires time to mature.
I know it’s a tough ask. Getting started with agile is hard enough, and I am preaching to you to add yet another effort to the mix. Unfortunately, the same way that thousands of biochemical processes happen only in the presence of enzymes, so also is agile in the pharmaceutical industry. You need to add a healthy dose of DevOps, for your agile transformation to take off.