IT Transformation Case Study – ERP Implementation For A Large Indian Pharmaceutical Company
We were looking at a Transformation project to be implemented for one of the sites in UK. This was identified as a part of the overall IT Transformation. The project had challenges involved due to Pharmaceutical Industry requirements on one hand and on the other side there were hurdles related to the IT Partners for lack of expertise on Pharma Domain. This engagement required Project Management activities to be precise and lot of standard activities had to be tweaked in-order to achieve the milestone in the given timeline.
Achievements:
- Overall, 120+ Man days effort was saved to the Business
- Overall, savings of USD 170K was achieved (People + Processes)
- Production and Warehouse processes were optimized by using RF technology. Rejection of goods were reduced. This further had scope for savings
- UK Plant was compliance / audit ready for any audits conducted by the Regulatory teams
- Implementation with the right IT Strategy and use of the IT consulting service experience ensured management of projects was effective.
The project was divided in multiple phases:
Project Initiation:
The IT Transformation activity had already been initiated in the Leadership meetings at an organization level. This project was one of the key tasks which were identified, resulting into the overall IT Transformation.
This phase required the involvement and buy-in of key stakeholders for approval of the Budget. The real need of the project was identified and documented in the form of RFP. The plan was to outsource the project to a SI Partner for implementation. Preparation of RFP was a major task, as documenting the exact requirement holds key to the project.
Key targets were identified: Automation of processes at site, Effective Reporting and Quality processes for Pharmaceuticals using the right tools were the targets to be achieved
Technology Stack: SAP ERP ECC 6.0 and Pharma QMS Tools.
Project Execution:
Post RFP circulation to IT Partners for implementation, the proposals were reviewed and the right partner was to be identified. SAP Consulting Partners who had immense experience in implementing such projects in the given timeline
Necessary SAP PMO layer was also formed for managing the Project efficiently.
Key Activities Performed:
- Current As-Is Process study
- To-Be Process Design
- Identification of Core team (Business / IT)
- Identification of Customization requirements
- Documentation of all the processes in URS, FRS, FRA. (Approval as per workflows defined)
- Testing with Pharmaceutical compliance norms. (21 CFR Part 11 regulations) (IQ, OQ and PQ)
- Final Data Migration and Cutover activities
- Integrations with SAP to Non-SAP Systems were built (Track & Trace)
SAP Module Scope:
Materials Management, Production Planning, Finance and Controlling, Warehouse Management, Plant Maintenance & Sales and Distribution modules.
During Implementation, project had multiple set of issues to be addressed. Pharmaceutical Domain experience, SAP ERP Limitations to Pharma industry, IT Partner Management and Pharma Compliance requirements.
Solution:
Effective Program / Project Management: This was the crucial aspect of the project. As mentioned earlier, Pharmaceutical industry had multiple compliance requirements. All the functionality were not available in standard SAP ERP. (Quality Inspection, Quality Management processes, Track and Trace and many other functionalities required integration to 3rd Party tools). Necessary customization requirements were identified and planned for development in advance. Other 3rd Party tools were used for QMS functionality.
The Testing evidence and recording of the detailed steps resulted in a time-lag which posed hurdles and delayed the project by 5 weeks. We had to club the OQ and PQ as one -> OPQ testing. This helped us save 3 weeks. The remaining 2 weeks were saved by managing the resources and activities by effective planning of tasks in parallel.
Considering the lack of domain level resources with the IT Partner, we had to spend more time in identifying the right set of resources with the IT Partner. End-user participation was crucial to all activities of the project.
We had planned multiple trips to UK during the key phases of the project. Logistics issues from India were also planned well. It involved collaboration with stakeholders from the Support teams.
Overall, the project plan had every activity detailed out, with the Responsibility assigned to every team member / user for planning and tracking. The Validation activities were also part of the Project Plan.
Project Adaptation:
Necessary Training requirements were identified for the core team. The users were provided training on the new processes. This involved a detailed end to end study with Train the Trainer approach. All the end user documentations were prepared for reference.
The overall success of the project highly depended on the adaptation of new system & processes by the end users at the UK site. Necessary Change Management Activities had also been formulated to ensure the user issues / queries were amicably resolved.
Project Closure and Handover:
The most important task was the closure of the project, where a smooth transition to the new system (SAP ERP ECC 6.0 + Quality systems) was targeted. Post go-live issues and stabilization of the system was key. The system was handed over to the Support team for regular issues / change requests.
Achievements & Learnings:
During the initial As-is Study, we focussed on the pain areas and identified some Key Performance Indicators (KPI’s). These KPI’s were tracked initially with regards to Time, Cost and Effort.
- Creation / Maintenance of Master Data
- Time for Procurement
- Financial Closing
- Inventory
- Approval of Purchase Orders
- Efficiency in Warehouse processes
- Track & Trace Automation
The To-Be Process were designed by keeping into consideration the above pain areas and overall automation required. All the learnings were documented for future projects. Knowledge documents were stored in the Central Repository.
Learnings:
- Onshore / Offshore Delivery were aggressive. India and UK Teams worked in different targets initially. This had to be re-aligned
- Local UK requirements were not captured well in the initial Gap Analysis study
- Time-zone management (EU and India) was crucial
- Training issues were identified. It had an impact on the go-live date
- Management of IT Partners and expectations set to them was critical
