Hybrid Agile methods are fundamental in tackling transformational complexity and maintain the highest levels of quality assurance within pharmaceutical enterprise change programs
An important aspect of many Digital Transformation initiatives within the pharmaceutical and life science sectors is the requirement to deliver projects and programs using Agile methods. Our clients recognize that technical excellence in transformational technologies – machine learning and AI, predictive analytics, cloud services, Internet of Things (IoT), Robotic Process Automation (RPA), etc. – only answers part of the transformational challenge. Partners also need to bring agility to the table to tackle transformational complexity, reduce innovation-cycle lead times, increase transparency, and drive the delivery of iterative and incremental value to the business. Due to the unique challenges found within these sectors, adopting one of the traditional Agile frameworks (Scrum, SAFe© (Scaled Agile Framework), LeSS (Large-Scale Scrum), Spotify, etc.) “off-the-peg” is not an option.
Key challenges to using Agile methods within the pharmaceutical sector include:
● Regulation and compliance – operating within a high GxP environment (Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice, etc.) gives rise to complex Computer System Validation (CSV) requirements and onerous compliance regimes
● Stringent quality control and assurance processes (business and IT) and complicated change control procedures as specified within client’s Quality Management Systems (QMS)
● In-house business change, value realization, and benefit tracking systems, mandating tightly controlled approaches to business transformation
● Complex business models and user requirements, for example, related to intercompany trade, tax, global supply chain operating models, and integration of modern ERP platforms (e.g., S/4HANA) with shop floor systems (manufacturing execution systems, laboratory information systems, etc.) and legacy ERP systems (e.g., JD Edwards)
These challenges have led many of our clients to develop in-house hybrid Agile methods which adapt and customize the standard frameworks according to the specific needs of the organization, industry, project, or work to be done.
Fusion Consulting has extensive experience in the creation and use of hybrid Agile frameworks. Our ERP and Project & Program Management Practices, often working in partnership with other industry suppliers, support our clients to develop customized Agile methods, which are used to facilitate greenfield and brownfield SAP-based transformation journeys. Use cases include implementation of SAP S/4HANA and ECC, core enterprise systems such as SAP Master Data Governance and SAP Ariba, and SAP and non-SAP SaaS cloud solutions.
Due to the level and complexity of pharmaceutical compliance requirements, the Scaled Agile Framework is typically used as the foundation for building up in-house Agile frameworks. SAP Activate, based on the Scrum framework, is another useful starting point, depending on the type and scale of the project (experience shows SAP Activate is more suitable for small to medium scale projects within the pharmaceutical and life science industries. On the other hand, hybrid Agile methods intended for major ERP rollouts are more typically based on the SAFe© framework).
With SAFe© acting as the foundation, we blend elements of other frameworks (SAP Activate, Spotify, etc.) with pharmaceutical industry best practices, lessons learned from prior engagements, and traditional waterfall processes related to change control, quality assurance, and testing. Work is typically organized into time-boxed sprints and managed via product backlogs with dedicated Product Owners and roadmaps. Detailed methods for decomposing work into Epics, Features, User Stories, and Tasks are defined. The software tools used to manage the decomposed work, for example, Jira or Azure DevOps, are identified and their functional requirements specified. This includes definition of custom fields and logic used to handle IT quality assurance processes and CSV requirements (e.g., GxP relevance and customized risk management procedures). At this stage, the “Definition of Ready” and the “Definition of Done” are defined, bearing in mind any specific requirements derived from the client’s QMS or requirements related to GxP compliance, CSV, or quality assurance.
A set of Agile deliverables is defined, each an output of one or more Agile ceremonies. The set of ceremonies defines the sprint cadence and gives structure (or rhythm) to the work done. Normally, ceremonies are defined based on the SAFe© framework and include standard sessions such as Sprint Planning, Sprint Reviews, and Sprint Retrospectives. Additional ceremonies are leveraged if required, including integration forums like Scrum of Scrums, Leadership Team Syncs, and Architecture Syncs. Integration of the framework with change control procedures is defined, as is integration with project and program design authorities, steering committees, and review bodies (e.g., architecture review boards).
Finally, roles and responsibilities are defined for all project participants, and composition of the Agile teams is specified. This includes detailed RACIs covering standard role definitions – Product Owner, Product Manager, Scrum Master, IT and business SMEs, etc. – project- or program-specific roles, for example, functional consultants and architects, and additional roles required under the client’s QMS (for example validation managers and quality, risk, or compliance officers).
The completed hybrid Agile framework is documented as a flexible playbook, underpinned by a focus on continuous improvement and adaptation based on lessons learned over the course of the project or program (or via BAU retrospectives if the framework is used in a steady-state environment). Detailed ways of working (WoW) such as the sprint structure, cadence, RACI, and deliverables typically vary according to the project phase (Exploration, Design, Realization, etc.) and different WoW are used depending on the technology stack and type of deployment. For example, hybrid Agile methods used for greenfield or brownfield S/4HANA deployments can vary significantly from those used to integrate SaaS applications or deploy intelligent apps to public clouds.
Hybrid Agile methods adapt and customize the standard frameworks according to the organization's specific needs, industry, project, or work to be done
Hybrid Agile methods provide many benefits. They are an opportunity to supplement proven frameworks such as SAFe© with industry best practices and lessons learned from previous projects, meeting the unique challenges faced in the pharmaceutical industry. This means the quality of deliverables is higher, project activities are more predictable and easier to manage, and management of risks and emerging issues is made easier. Delivery of value to the business is iterative and incremental (“little and often”), enabling innovation and increased transparency, which in turn means stakeholders are easier to engage and senior sponsorship is easier to maintain. And crucially, this is done whilst maintaining compliance with the GxP regulations, compliance standards, assurance processes, and validation requirements demanded by the industry.
