iSpeak Blog

Agile Software Development in GxP Regulated Environments Special Interest Group

Mark R. Cherry
Donal L. O'Brien
Andrew Mcdonagh
Stephen Jones
Staci Dubovik
Agile Software Development in GxP Regulated Environments Special Interest Group

There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation.

There are some who even claim that the GAMP® 5 validation approach requires this!

The above are simply not the case, as GAMP® 5 promotes a risk-based approach to validation and does not define the software development methodology lifecycle.

In order to help people, understand how Agile software development methods can be used in GxP solutions, a Special Interest Group (SIG) was established led by Donal O’Brien and Mark Cherry.

Suppliers who often perform their base product development using Agile but then feel they need to provide something to the pharmaceutical company that looks like it was waterfall.

Andrew McDonagh

What has been done so far?

The special interest group has in fact been running for over a year with the initial activities being focussed around the special interest group members providing presentations and input on their approach and maturity in using Agile Methods.

The special interest group membership has a good mix of pharmaceutical companies, suppliers and integrators as well as consultants and academics, which has provided a rich vein of available material.

Have the approaches been very similar?

Put bluntly, no not at all. There is a very broad spread of levels of adoption of Agile, especially in end user pharmaceutical companies but also with suppliers who often perform their base product development using Agile but then feel they need to provide something to the pharmaceutical company that looks like it was waterfall.

In the worst cases perfectly sound agile software development activities are performed with the necessary deliverables (often these are within toolsets rather than documents) which are then reverse engineered to produce a suite of traditional documents; this is wasteful and potentially very confusing as then two sets of deliverables need to be maintained/aligned through the system lifecycle. It also raises the risk of a compliance failure, should there be a difference between the two that is subsequently discovered during an audit. It raises the question of where the source of truth lies.

Has the approach of the special interest group remained the same?

No, we were initially going to collect the input materials and maybe publish an article showing the different typical stages organisations are at. However, on review we have decided we need to be bolder and more aligned to the emerging thinking from regulators about becoming more risk-based, applying critical thinking, and moving away from bureaucratic approaches that do not add value.

This recent blog article by Sion Wyn describes the FDA Case for Quality initiative and how GAMP® 5 aligns to this.

As clearly stated in the blog and the associated Pharmaceutical Engineering Article, Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program, supports the use of incremental, iterative, and evolutionary approaches including Agile, for product development and development of custom applications. Also, the FDA CDRH Case for Quality initiative clearly supports the adoption of appropriate Agile approaches, in order to encourage innovation, eliminate unnecessary costs, and help focus on real quality and fitness for intended use.

So what are you proposing now?

Through the special interest group meetings and materials, we have identified 6 themes that are often pain points for organisations wanting to use Agile in GxP and so we are proposing to publish a series of ISPE iSpeak BLOG articles every two months on each of the following topics:

  • Certainty Mindset vs a Discovery Mindset
  • User Requirements
  • Continuous Testing instead of testing at the end
  • Validation & Compliance in an Agile World
  • Tools instead of documents
  • Bringing together System Development and Operations

In our next article….

We will be delving into the differences and benefits of agile, including a comparison between the traditional Certainty Mindset, and the Discovery Mindset that is key to product development.