Authors: Chong Yang Gue and Dr. Thaleia Papadopoulou
If you missed How Pharmaceutical Companies Can Implement Agile Methodology Part 1 of 2 about how to successfully implement Agile in pharma, we suggest you start there to learn about general Agile development methodology and, specifically, how it can be incorporated in an Agile pharmaceutical development environment. In part 2 we look at the tests and approval approaches adopted in Agile applications within GxP scenarios.
How to Manage Agile Testing and Approvals
1. Achieve a minimal viable product at each sprint
Agile demonstrates performance “according to intended use” via testing within each sprint, allowing for a “minimal viable product” (works but with minimum functionality) at the end of each sprint. This approach ensures each sprint achieves the maximum result possible with the least effort (80/20 Principle). This is the main contrast between Agile and the layers of testing activities that are performed with Waterfall/linear models.
5 Good Testing Practices for Agile
- Discovery & Automation A combination of exploratory testing with test automation
- Regression Testing Use regression testing to ensure that sprint developments do not impact the functionality of already-developed software
- Early Demo Show walk-throughs or demonstrations to business owners to visualize the system and identify potential issues early on
- Minimal Final Acceptance Testing Agile prioritizes a staggered approach instead of a one-time delivery/testing approach that minimizes the final acceptance testing
- Good Test Management Platform Test activities and records are managed and stored within a test platform that’s referenced against the MVP and DoD (Definition of Done)
2. Dispel the Myth that Agile Lacks Planning and Control
A common misconception is that Agile presents a GxP challenge in maintaining a state of control because of the rapid pace at which changes occur. The latest GAMP guide argues against this notion, stating that when Agile is operated correctly, it shows its strength because it combines rapid change with delivery of working software.
“Correct operation” is defined by the usage of Agile processes that are:
- Well managed
- Under control
- with joint team accountability
- by using tools that provide oversight
3. Emphasize Acceptance Rather than Approval
Approvals, in the form of sprint backlog approvals, are required and used in the Agile approach and the respective roles and responsibilities are assigned during the planning phase. However, sprint backlog approvals should not be confused with the approval of the <link back to URS document>, which is common practice in the linear/Waterfall model. Creating a URS type of document for approval by using a tool-based sprint backlog is a common pitfall that the GAMP guide recommends avoiding. The rationale against such practices is that they create duplicate information, posing a high risk for errors. For example, a backlog-export document can become easily outdated over time with the actual product backlog, tests, and code. The guide notes that a single “source of truth” is much more important than the existence of a “traditional document” that is no longer needed.
4. Prioritize the Right Tool VS Signature
The GAMP guide clarifies that an approval does not necessarily need to be accompanied by a signature unless the approval is a predicated signature/approval by regulation. When it comes to software lifecycle deliverables, signatures are only mandated for Software as a Medical Device (SaMD), or if the software is embedded in a regulated medical device. For every other case within the pharmaceutical industry, a regulated company is free to employ alternative approval methods such as:
- Status change
- Audit trails
The above methods are easily implemented in Agile because they are already incorporated—or are expected to be within—the commonly used tools for lifecycle management. A good example is change logs, which record information such as who did what and when against each <link to PBI>, but change logs can also be configured to enforce security rights to control which functions/roles perform certain tasks.
These change logs also have a start-sprint concept with the capability of recording the start of the sprint clock and the sprint backlog and which PBIs are approved to be worked on during the sprint. These records are commonly used by Agile teams instead of URS document signatures. In addition, as the sprint proceeds and the PBIs are worked on, they typically transition from a “To Do” state to an “In-Progress” state and finally to a “Done state”. All these changes take place once the team and the product owner are satisfied that the PBI meets the criteria set by the MVP and DoD and by restricting who can perform changes to different PBI statuses (usually only the product owner). The team can provide records of evidence that the PBI is completed to a satisfactory point, tested, and finally accepted.
GxP-CC Can Help You Solve Compliance Challenges
The pharmaceutical industry doesn’t need to be afraid of using tools, because these are recognized and approved by regulators as a sensible way to maintain and manage GxP-CC records and have proven to be more efficient than paper documentation.
It’s important to note that many high-risk industries such as medical devices, defense, and power have already implemented requirement management tools over the last two decades.
If you need help overcoming your Agile challenges, or have any questions, please contact us at firstname.lastname@example.org.