Client Success Story

Background

A global leader in the Life Sciences industry seeked to transform their software delivery processes to enable a seamless agile delivery platform for GxP and non-GxP solutions.

The company had previously been on an agile transformation journey for non-GxP software solutions. The digital organization was ready to expand their processes to include GxP software systems.

The executive team had an ambitious goal to transform their operating procedures, delivery models and software delivery technologies to seamlessly integrate into an automated and GxP compliant agile platform.

The digital organization had over 600 people spread across multiple organizational units and functions. Each area was to transform to utilize the platform to deliver value driven software solutions faster and more cost effective.

Company size

Revenue

Scope

60,000+ employees

$40B+

IT organization (600+ people)

The Challenge

The end to end software delivery process needed to be transformed, including the computer system validation approach, technology tools and overall delivery processes.

The legacy process followed waterfall delivery processes. The new process needed to be reinvented, restructured and replanned to focus on value and effectiveness while ensuring regulations are met.

To meet regulatory controls, the mandated documents needed to be created and controlled following regulatory guidelines. The current process for creating the documents was highly manual. The tools used to enable processes, such as system requirements and verification, were outdated and difficult to integrate.

Additionally, stakeholders across the digital value stream must be bought into the vision and represented across their functions or the approach cannot be successful. Cross functional stakeholders include quality and compliance, security, product delivery and engineering, executive leadership and business partners. Change management needed to be a key enabler to transform and sustain the new ways of working.

Timeframe

Scope

Deliverables

2 years;

Kickoff to scaled success

Entire SDLC process Documentation, tooling and procedures

Automated GxP agile delivery platform

Our approach

We started with assessing and inventorying the current SDLC(software delivery lifecycle) landscape; CSV documents, tooling and procedures.

Using the outputs of the assessment, we focused on designing an approach based on multiple work streams;

• Compliance and CSV work stream to rethink and redevelop the process

• Agile tooling work stream to standardize and integrate technology delivery tools into an integrated GxP-compliant delivery platform

• Program management and change management to ensure the organization remained aligned through the process

Once the platform and process was built, we identified a pilot team to onboard onto the delivery platform and execute following the redesigned processes and tools. We partnered with the pilot team to support, modify the approach where needed and build a playbook for deploying throughout the organization.

Once the pilot was successful, we create a deployment roadmap to scale across the organization based on agile maturity and readiness. We continued to share success stories and evolve the platform as additional teams onboarded and utilized the new framework.

Approach

Platform Capabilities

Workstreams

• Assessment

• Pilot

• Organizational scaling

Seamless enablement

Automated CSV documentation, Integrated agile tooling, CI/CD engineering automation

Compliance & CSV, Agile tooling, Change management

Key Client Successes

• Unified, GxP-compliant agile delivery platform

  • Standardized processes and tooling for 600+ employees while embedding compliance by design and reducing regulatory delivery risk

• Accelerated time-to-value while maintaining compliance

  • Transitioned from manual, waterfall-based CSV to an automated, agile SDLC, resulting in faster release cycles, earlier business value realization, and significant reduction in validation effort and rework.

• Reduced cost and operational complexity

  • Drove material reductions in manual documentation and release processes resulting in lower cost per release, and improved traceability and streamlined operations

• Sustainable organizational change at an enterprise scale

  • Aligned quality, compliance, security, engineering, product, and executive leadership through structured change management, achieving high stakeholder adoption, consistent ways of working, and a foundation for continuous improvement.

40%

reduction in validation documentation effort

10%

Reduction in cost per software release

20%

faster time to release for software solutions

Want to discuss more or see how we can help?

Contact us for a personalized discussion and see how we can help

Contact Us