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Measuring the potential for digitalization in the field goes beyond simply asking "what software is in place?"; it's about where the data is generated, how it's transferred, who approves it, how traceable it is (audit trail), and how visible the processes are from end to end. The following 20 questions help quickly understand digital maturity across production, quality, maintenance, warehousing, purchasing, and reporting axes, and identify priority areas for improvement.
How should you use this list in the field?
If possible, evaluate these questions not with just one department, but with at least one representative from each of the production, quality, maintenance, warehouse, purchasing, and IT stakeholders. While obtaining the "current situation" answer for each question, also verify the truth with sub-questions such as: "Who is entering?", "How often?", "Where are the records kept?", "Can you produce retrospective evidence?"
Quick Rating Suggestion
- 0: Completely manual / paper / Excel-email
- 1: Partially digital but not integrated (island systems, manual transfers)
- 2: Digital and standardized, but lacking end-to-end traceability.
- 3: Digital + integrated + audit trail + role-based authorization/flows
This scoring system reveals which modules/systems are needed, where process design (workflow) and integration layers are required, and where user adoption/training is necessary.
What should the evaluation outcome be?
- Risks: Data integrity, audit trail, delay, error rate.
- Quick wins: Bottlenecks that can be digitized in 30–60 days.
- Medium term: Integration, mobile field workflows, automation
- Long term: KPI/BI layer, advanced planning, end-to-end traceability.
20 Questions (with explanations and subheadings to be asked in the field)
1) Is data/information still shared between departments such as production, maintenance, and quality via Excel or email?
Sub-questions: Who prepares the daily reports? How are file versions managed? Are multiple copies of the same data circulating?
What it teaches us: If information flow is not centralized, integration is weak; decisions are delayed, and a "single source of truth" does not emerge. Presenting evidence in audits becomes difficult. This situation points to the need for process management (workflow), an integration layer, and standardization.
2) Are systems other than SAP, such as LIMS, MES, BMS, and EAM, actively used, or are all processes carried out within SAP?
Sub-questions: Where are the quality results stored? On which screen are maintenance work orders created? Who can see the environmental monitoring data, and from where?
What it teaches: If there are multiple systems, integration is a critical issue. If it's said "everything is in SAP," it needs to be verified whether SAP is actually being used in the field; often, practical operations have shifted to Excel. This question clarifies which functions require specialized systems.
3) Are production orders and batch records (EBR) digital, or are paper forms still in use?
Sub-questions: Which form is the operator filling out? How is the revision check performed? What is the number of wet signatures and the total cycle time?
What it teaches us: Paper-based EBRs create risks of delays, lost records, erroneous entries, and data integrity. It demonstrates the need for digital EBR/MOM/MES and the necessity of an electronic record-signature infrastructure.
4) Are material receipt and delivery note entries manually entered into SAP, or are they integrated with warehouse systems?
Sub-questions: Is barcode scanning available? How are quarantine/release labels printed? Are lot/expiration date errors frequent?
What it teaches us: Manual entry increases the risk of errors, especially in critical areas like lot/expiration dates, and reduces inventory accuracy. This highlights the need for WMS/barcode flows and warehouse integration.
5) Can the weighing and production devices share data with SAP or another system?
Sub-questions: Is the weighing data entered manually? Is the data automatically recorded by the device? Can the calibration status be viewed by the operator?
What it teaches us: Lack of device integration increases reliance on manual operator input. This leads to higher error and rework rates. It highlights the need for MES – Equipment Integration or an IoT/OPC gateway.
6) Are the quality control test results automatically recorded in the laboratory, or are they entered manually?
Sub-questions: Where is the analysis device output stored? How are the results transferred to SAP? Are the re-analysis/OS–OOS processes followed?
What it teaches us: The absence or low usage of a LIMS weakens traceability. Manual entry poses risks in terms of electronic record keeping and audit trails. It reveals the need for LIMS and LIMS-ERP integration.
7) Are fault/maintenance reports submitted by field personnel via mobile devices, or are they entered from the office?
Sub-questions: What is the troubleshooting time? Can photos/attached files be attached? Is the distinction between reactive and planned maintenance clear?
What it teaches us: If there's no mobile flow, notifications are delayed, data is missing, and maintenance becomes reactive. This question helps us understand EAM maturity, the accuracy of KPIs like MTTR/MTBF, and the need for field implementation.
8) Is there a frequent discrepancy between inventory levels in SAP and physical inventory (frequency of manual adjustments)?
Sub-questions: What is the frequency of counting? Is a root cause analysis performed when a discrepancy occurs? In which product groups do discrepancies occur most frequently?
What it teaches us: Frequent corrections indicate weak warehouse discipline, barcode flow, or integration. It signals the need for WMS/scan-based operations and standardized warehouse processes.
9) Are cold chain or environmental data (temperature, humidity) monitored with sensors, or are they collected through periodic measurements?
Sub-questions: Is there an automatic alarm for limit overruns? How many years are the records kept? Are deviations correlated with CAPA?
What it teaches us: Manual measurement carries the risk of forgetting and delaying. Sensor + automatic recording is critical for environmental monitoring, quality assurance, and audit readiness. It demonstrates the need for BMS/IoT infrastructure and integration.
10) Is the product release (QA Release) process handled through SAP, or are signed forms still being used?
Sub-questions: How many approvals does the release go through? Is a re-signature required for revisions/changes? Is there an electronic signature and audit trail?
What it teaches: Paper-based processes create bottlenecks in speed and traceability. Digital e-Release standardizes approval workflows, reduces delays, and provides audit trails. QMS workflow and e-signature requirements become clearer.
11) Are manual interventions or Excel spreadsheets used in production planning processes (MPS/MRP)?
Sub-questions: How is plan revision managed? Are capacity constraints calculated? Which report is used to monitor material availability?
What it teaches: Excel planning weakens scenario management and visibility. If MRP/MPS usage maturity is low, enabling planning modules and advanced planning approaches creates opportunities.
12) Are purchase approval processes automated in SAP, or do they proceed via email/PDF circulation?
Sub-questions: Is the approval hierarchy clear? Is there budget control? Are the reasons for rejected requests recorded?
What it teaches us: Email approval means non-standard practices and a weak audit trail. Digital approval workflows provide transparency, speed, and compliance. The need for authorization matrices and workflows becomes apparent.
13) Are ITS/PTS (Drug Tracking System) operations managed through SAP, or is there a separate system or manual upload?
Sub-questions: Where is the serialization data stored? Has a recall simulation been performed? What is the loading failure/rejection rate?
What it teaches us: Manual processes break serial/lot traceability and prolong recall times. The need for ITS integration, automated data flow, and end-to-end traceability arises from this question.
14) Are equipment calibration, validation, or maintenance records kept digitally?
Sub-questions: Where is the calibration schedule? How are overdue calibrations reported? Is there version control in the validation documents?
What it teaches us: Paper records create weaknesses in CAPA and audit processes. It demonstrates the need for EAM + QMS integration and equipment lifecycle management.
15) Are parameters such as energy, water, steam, and pressure monitored through the system, or are manual meter readings taken?
Sub-questions: Is real-time consumption visible? Are there alerts for deviations? Are sustainability KPIs reported?
What it teaches us: Manual meters are weak in terms of data continuity and accuracy. Energy monitoring/BMS is a powerful leverage for cost control and sustainability goals.
16) Can supplier evaluation or performance tracking be done through SAP?
Sub-questions: Are there metrics like OTD (Overall Delivery Time) and quality score? Are supplier CAPA processes monitored? Is alternative supplier benchmarking performed?
What it teaches: Risks remain invisible if supplier performance isn't measured. With a QMS or procurement performance module, supplier KPIs, actions, and traceability are strengthened.
17) Are dashboard/KPI reports generated within SAP, or are external systems like Power BI/Excel used?
Sub-questions: How often are KPIs updated? Is there a single data source? How many hours/days does report generation take?
What it teaches us: External reporting is normal; however, KPI reliability decreases if source data is scattered. The need for a BI layer, a centralized data model, and self-service reporting becomes clear with this question.
18) Are user permissions, approvals, and log records automated in the system, or are they based on manual approvals?
Sub-questions: Are authorization changes being recorded? Is it possible to see who changed what and when? Is an electronic signature being used?
What it teaches us: The absence of an automated log/audit trail is a critical risk for compliance and auditing. It creates a need for role-based authorization, electronic signatures, and audit modules.
19) Which system is used to provide product/batch/lot-based traceability (SAP, Excel, or neither)?
Sub-questions: Did you run a recall exercise? How long does it take you to generate the lot tree? At which process step is the data lost?
What it teaches: Traceability is not just about lot numbers, but about linking process steps. Poor traceability poses a serious risk in terms of recalls, audits, and quality assurance. It highlights the need for MES/EBR and data models.
20) Are there mobile/tablet-based applications for field personnel, or are all records entered from the office?
Sub-questions: Is offline work required? Are user trainings planned? What is the delay in data entry from the field?
What it teaches us: Without mobile access, data is delayed, accuracy decreases, and user dependency increases. Mobile field flows provide real-time visibility, faster action, and a more robust audit trail.
Result: 3 Clear Outcomes for the Digitalization Roadmap
- Maturity map: Which processes are “manual,” where are “semi-digital,” and where are “integrated”?
- Priority list: Highest risk and fastest recovery areas (EBR, LIMS, WMS, mobile maintenance, approval workflows)
- Integration plan: Inter-system data flow, audit trail, role-authority and reporting architecture.
This 20-question assessment reveals how things work in the field and allows you to position your digital transformation investments based on tangible risks and benefits, not on "trendy" technology.
