Validation of SAP S/4HANA and WAMAS for a pharmaceutical manufacturer

The group already had its SAP S/4HANA validated. The expansion changed everything: a new company, a new facility and an automated warehouse governed by a WCS. The SAP rollout to the new company and the platform upgrade made it necessary to review the validated state of a system that underpins finance and controlling (FI, CO), purchasing and materials (MM), extended warehouse management (EWM), production planning and control (PPDS, PP, PC), quality and quality assurance (QM), maintenance (PM), sales and distribution (SD), document management (DMS) and human resources (HCM).

The risk was not documentary, it was operational. This is a highly automated environment, with two complex systems that run the processes with very little human intervention: if the logic that WAMAS executes on SAP's behalf is not qualified, there is no operator to correct the movement of a pallet between warehouse, production and material dispatch. On top of that came the demand for short project timelines, driven by the start-up of the new facility.

The architecture added its own difficulty: on-premise components (Content Server, EHS WWI, Uhlmann Pexcite line control servers) coexisting with SAP BTP, SAP Public Cloud and HANA Enterprise Cloud, plus integrations with production equipment, quality control equipment, public administrations and electronic invoicing. The client's stated objective was to comply with FDA and EMA standards for computerised systems.

We applied a validation methodology in line with GAMP 5, risk-based and covering the entire system life cycle, across the two perimeters: SAP (rollout to the new company and upgrade) and WAMAS.

• Two complete documentation kits, one for each of the group's two companies, generated in accordance with the client's quality system.
• Full validation of WAMAS, covering receipt and storage, institutional dispatch, private market and export, supply to primary and secondary/tertiary packaging, manual picking, stock reservations, supply to production, waste handling and stock blocking and unblocking.
• Documentation cycle per system: Validation Plan, user requirements (URS), Design Qualification (DQ), Risk Assessment, protocols and execution of IQ, OQ and PQ, residual Risk Assessment, Traceability Matrix (MX) and Final Validation Report.
• Management of 5 relevant GxP suppliers: documentation of the product and intended service and supplier audit to verify their alignment with the client's technical, IT, operational and regulatory requirements.

The scope included the components hosted at the client's facilities and the cloud services (SAP Cloud Platform Integration, SAP Cloud for Customer, SuccessFactors, Concur, SAP Analytics Cloud, Enable Now, Adobe Forms, Cloud Connector, Web Dispatcher), as well as user access through Fiori.

On the client side, the competence centre, quality assurance and validations and the managers responsible for the automated processes took part. On the OqoTech side, management —responsible for regulatory compliance and resource allocation—, two project managers and six validation consultants.

Both group companies ended up with their SAP S/4HANA validated after the rollout and the upgrade, and the automated warehouse with its WAMAS WCS validated across the inbound, supply to production, dispatch and stock management processes, including the logic it executes through integration with SAP.

The client has two complete documentation kits, one per company, with Validation Plan, URS, DQ, Risk Assessment, IQ, OQ and PQ protocols and reports, residual Risk Assessment, Traceability Matrix and Final Validation Report, all traceable under its quality system. To this is added the file of the 5 GxP suppliers assessed and audited.

On completion of the first SAP validation, the client passed an inspection by the Brazilian health authority with no applicable comments on the validation.