Overview

Ensuring efficient use of technology to support process is important from a strategic and operational point of view. We assist in ensuring that the IT strategy aligns with the business needs, and that IT budgets provide the most capabilities for the available budget.

Implementing solutions not only encompasses technology but also requires implementation of new processes, communicating and training of end-users and ensuring everything is validated in accordance with regulatory requirements.

Once a new solution is selected and the right vendor is found, we can be the implementation partner and by using an agile method, effective vendor management with focus on processes, Out of Box (OoB) functionality, GAMP 5 documentation, we can ensure that the project will stay on budget and to the agreed timeline. Key input is good requirements, aligned with business and with the vendor.

Proper solution implementation includes multiple services described in this document e.g.:

• Vendor and Application selection – Evaluation of vendors is done with an objective approach both in terms of commercial fit, IT and Quality Compliance and capabilities based on our methodology.
• Implementation of solution – Using an agile method, effective vendor management with focus on processes, Out of Box (OoB) functionality, GAMP 5 documentation, while staying on budget due to good requirements.
• User Requirements (URS) and Use Case (UC) Development – User Stories and User Requirement Specifications, supporting new SOPs, Configuration Specifications, all aligned to save time and effort when implementing and maintaining the system.
• RFI/RfP services – Experts in both creating the necessary RfI/RfP packages and in running the demonstration and scoring process to ensure an objective selection result.
• System configuration workshops, documentation, and application setup.
• Validation Management, where the solution is validated per GxP against business, IT, and regulatory requirements.
• Migration services, where data from old source systems are copied to new solutions.
• Process Optimization, where existing processes are updated or new are developed (including SOP and Wis).
• Organizational Change Management – HERAX creates a comprehensive change management plan where awareness and training in new processes and solutions is communicated and carried out.

HERAX applies an agile approach to solution implementation and drives the implementation of the selected solution through the activities of process definitions (Use Cases), configuration, fit-for-purpose testing, and deployment while managing all stakeholders. The approach ensures an optimal process development, migration, validation, and relevant change/communication series of activities and finally handover to operations. The implementation includes project management including detailed plans, weekly plans, progress reporting, risk, and issue management.

Agile Digitalization & Implementation

Planning and developing new solutions in a regulated environment have traditionally not been very flexible.

HERAX has taken the SAFE® methodology and incorporated it into our pharma business architecture methodology, ensuring a flexible and fast implementation.

It ensures the team is productive, and delivers continuous results during the project.

An agile approach combined with a risk-based validation method ensures a cost-effective test of only configured
business and regulatory requirements.