Issue

The detailed design phase has commenced, during which standard SAP functionalities were reviewed in collaboration with the GBUs. This process revealed notable differences in operational approaches across GBUs, highlighting the need for alignment. To address this, a series of targeted workshops were conducted per GBU, resulting in a harmonized business process model accepted as a global template. Concurrently, the business expressed interest in revisiting the potential replacement of Labware/LIMS with standard SAP QM. A comprehensive demo was conducted to showcase complex business processes—particularly those not covered during the conceptual design phase and in light of the CUI topic. To further explore system capabilities, the Labware team conducted a reverse demo to better understand the intricacies involved.

The list of used LIMS is in the below:

Recommendation

When an organization is undergoing a transformation program, choosing SAP over a standalone LIMS for inspection results recording can offer strategic advantages that go beyond just functionality. Below are the key recommendations and rationale:

1. End-to-End Integration Across Business Processes

• SAP QM is natively integrated with modules like MM, PP, EWM, and PM.
• Inspection results can directly trigger follow-up actions (e.g., stock postings, usage decisions, batch status changes) without middleware.
• Reduces data silos and ensures harmonized workflows across procurement, production, and logistics.

1. Single Source of Truth for Master Data

• Material Master, Inspection Characteristics, and Quality Info Records are centrally maintained.
• Avoids duplication and misalignment that often occurs when LIMS operates as a separate system.
• Supports global harmonization and standardization—perfect for transformation programs aiming for operational excellence.

3. Compliance and Audit Readiness

• SAP’s audit trails, electronic signatures, and role-based access controls are built-in.
• Inspection results are traceable to batches, vendors, and production orders.
• Facilitates compliance with GxP, ISO, and other regulatory frameworks without needing external validation layers.

4. Cost and Complexity Reduction

• Eliminates the need for complex LIMS-SAP interfaces (e.g., QM-IDI or custom RFCs).
• Reduces and simplifies change management during transformation.
• Leverages existing SAP infrastructure and licenses.

5. Real-Time Analytics and Reporting

• Inspection results feed directly into SAP’s analytics tools (e.g., Fiori apps, SAC dashboards).
• Enables proactive quality monitoring and decision-making.
• Supports KPI tracking aligned with transformation goals.

Background & Context

There are some requirements to be considered in context together with topic of this KDD.:

• The table below illustrates the SAP vs LIMS Usage for the GBUs.

SAP should be able to cover the above activities.

Composite GBU specific requirements to be covered are the below:

• Manage Customer Specifications.
• Manage Production In-Process Controls for the Parent Batches.
• Manage Quality Inspection for the Produced Stock Batches.
• Manage “Conditional” Inspections (To be inspected if a previous Inspection Characteristic fails).
• Manage Calculated Characteristics depending on the previous results of other Characteristics.
• Manage Inspection Lot consolidation where an Inspection Lot should be automatically rejected if the previous Inspection Lot was rejected.
• Manage complex Sampling Procedures.
• Manage PRT Usage during the Quality Inspection Process.  

For managing Customer Specifications the below scenarios should be covered:

• A Material against multiple specs:

• Sales Orders against Multiple Specs:

The same customer can ask for the same product certified under different specs.

Some distributors ask certification in all possible specs to be able to sell to any requirement.

• One Process Order - Multiple Rolls against Multiple Specs:

The rest of the GBUs shares the below requirements:

• To be able to effectively manage Master Data.
• Create Inspection Lots based on the different scenarios such as Incoming Goods or Production GR.
• Record Inspection Results.
• Manage Sampling Procedures based on different rules like Quantities or based on the Production duration. 
• Effectively manage the UDs based on the Inspection Results recorded.
• Effectively retrieving the CoA of different inspection Batches.

The initial Integration model validated between SAP and LIMS is the below:

Assumptions

• To enable seamless inspection result recording, laboratory equipment should be interfaced directly with the SAP system, allowing automated data capture, improved accuracy, and real-time integration into quality management workflows and analytics.
• To enable automated sample drawing during the production process, a clearly defined sampling procedure or rule must be communicated. If sampling occurs randomly without a consistent or logical pattern, the process will default to manual execution.
• The proposed solution must support the inclusion of additional inspection samples throughout the quality control process, ensuring flexibility in response to evolving production conditions or specific quality concerns.
• "The solution must support the recording of inspection results against multiple specifications, enabling flexible evaluation criteria tailored to diverse product requirements, regulatory standards, or customer-specific needs.

Constraints

N/A

Impacts

• Additional interface objects should be incorporated into the project scope, with a thorough evaluation conducted to identify the most effective integration approach based on system architecture, business requirements, and operational efficiency.
• Enable automated selection of relevant Master Inspection Characteristics and specifications during inspection lot creation, ensuring consistent application of quality criteria and reducing manual configuration effort. 
• For the Composite GBU, transitioning from Labware to SAP may necessitate customer revalidation of the testing process to ensure continued compliance with CUI and ITAR regulatory requirements.
• The initiative entails substantial change management and training efforts, requiring targeted strategies to ensure user adoption, minimize disruption, and build competency across impacted teams.   

Business Rules

• All Inspection Lot triggers are properly defined (e.g., Goods Receipt, Production Order, Stock Transfer).
• The Inspection Types defined during the Detailed Design are correctly assigned to the Material Master.
•  Standardize MICs across plants and materials to ensure consistency.
• MIC Specifications will be mentioned in the Inspection Plans and not on the level of the MIC itself avoiding duplicating of them.
• Assign sampling procedures based on inspection scope and regulatory needs.
• Automate sample size calculation where logical rules exist.
• Default to manual sampling if randomness or non-standard triggers apply.
• Automate selection of specifications based on material, Customer/Vendor, or batch attributes.
• Support multiple specifications per inspection lot when needed (e.g., customer-specific vs. internal standards).
• Ensure fallback logic if no valid specification is found.
• Enforce mandatory result entry for critical characteristics.
• Allow optional recording for informational or non-critical specs.
• Enable integration with lab equipment for automated data capture.
• Define valuation logic (e.g., accepted, rejected, conditional acceptance).
• Link usage decisions to follow-up actions like stock postings or notifications.
• Automate decisions where possible based on recorded results and valuation codes.
• Ensure seamless data flow between QM and IM, Manufacturing, EWM,S2P and A2D.

Options considered

Option A: Keep the AS-IS system usage

Currently, SpP, TS, and Composite business units utilize Labware for inspection results recording, while Novecare operates on WebLIMS. One proposed option under consideration is to maintain their existing systems, allowing each unit to continue using its current platform to avoid disruption, preserve validated workflows, and minimize revalidation efforts.

The SAP S/4H integration model will be as the below:

Advantages:

Since LIMS is already fully configured and operational, no additional effort is required to adapt SAP S/4HANA for inspection results recording. This minimizes the need for system reconfiguration, reduces training demands for end users, and significantly lowers change management complexity. Moreover, maintaining the existing setup avoids triggering customer revalidation processes, ensuring continuity and compliance with current quality and regulatory standards.

Option B: Use only SAP for the Results Recording

The second option involves leveraging the full capabilities of SAP S/4HANA’s Quality Management (QM) module for inspection results recording. This approach enables seamless integration across procurement, production, and logistics, eliminates interface complexity, and ensures a unified source of truth for master data. It also delivers real-time analytics, embedded compliance features, and end-to-end traceability—making it a strategic fit for harmonized global operations and enterprise transformation initiatives.

This option will involve the Development for the below activities in SAP:

Option C: SpP, Novecare and TS will use SAP for the Results Recording and Composite will remain in the Labware. 

Under this option, SpP, Novecare, and TS will transition to SAP S/4HANA for inspection results recording, while Composite will continue operating within Labware to preserve its validated setup. This approach avoids additional development for Composite-specific requirements, enables harmonization and standardization across the other business units, and delivers the benefits of Option A—without incurring the integration and revalidation challenges associated with Option B.

Describe the option in sufficient detail for a reader familiar with the subject matter to understand it properly

Evaluation

Outline why you selected a position. The best format could be a pro/con table (sample below), but is up to you as the author. You must consider complexity, feasibility, cost/effort to implement, but also ongoing operational impact and cost. You must consider the program principles and explain any deviations in detail. This is probably as important as the decision itself.

See also

Insert links and references to other documents which are relevant when trying to understand this decision and its implications. Other decisions are often impacted, so it's good to list them here with links. Attachments are also possible but dangerous as they are static documents and not updated by their authors.

Change log