Regulatory requirements affect what companies can change in SAP and how they must test those changes. Five LeverX projects show how transformation works under these constraints and what businesses can achieve.
An SAP transformation is demanding enough when the team has to rethink processes, move data, and keep the business running. In highly regulated industries, even a change to an approval workflow can require additional checks that will add to the work involved in improving a process.
Yet that extra work does not have to put improvements out of reach. Five LeverX projects in life sciences, chemicals, and energy show how companies addressed specific regulatory and operational demands while improving the systems their teams use every day.
|
TL;DR
|
What Regulatory Requirements Mean for an SAP Project
Regulatory requirements become system requirements wherever SAP supports a regulated activity. If the company must restrict who approves a transaction, retain its history, or submit information in a prescribed format, the solution has to support those obligations. This affects the project in several ways:
Required controls limit process changes
Removing an approval step may shorten a workflow, but it can also remove a required check. The team therefore has to preserve that control or establish an acceptable alternative. Data protection requirements can also constrain the design.
For example, where the General Data Protection Regulation (GDPR) applies, Article 25 requires safeguards that limit personal data processing by default to what is necessary for each purpose. A proposed workflow that gives more employees access to personal data may therefore need narrower permissions, adding configuration and testing work.
Local obligations add scope to global rollouts
Countries can require different invoice formats, tax reports, and submission methods. A shared SAP template may therefore need local extensions and connections to authorities’ systems. Each variation adds configuration, integration, and testing effort.
Evidence requirements affect acceptance and timing
For pharmaceutical activities covered by Good Manufacturing Practice (GMP), EU GMP Annex 11 calls for validation based on a documented risk assessment. The project must therefore include time to produce and review evidence that the system performs as intended, with the testing effort reflecting the risks involved. Findings that affect acceptance can require corrections and further testing, delaying production use even when the technical implementation is complete.
Changes in requirements create work after launch
A revised reporting format or submission rule can require changes to configuration and integrations. Those changes then need testing before use, making regulatory maintenance part of the ongoing support workload.
LeverX’s SAP Transformation Projects in Pharma and Life Sciences
Pharmaceutical and medical device companies need to improve how they work while maintaining strict product quality controls. During an SAP migration, production must continue with minimal disruption, as downtime can affect manufacturing schedules and product availability. Quality Management (QM) processes also need to remain reliable, including inspections, batch traceability, and the records used to demonstrate regulatory compliance. Changes to these functions can require additional validation before the new system goes live.
LeverX helps customers plan SAP transformations around these requirements, identifying which processes can change and how to preserve critical controls throughout the transition. The projects below show how this works in practice.
Enable Injections: SAP implementation to support business growth
Enable Injections develops and manufactures body-worn devices that allow patients to self-administer medication.
Challenge
As the company grew, QuickBooks and paper-based processes made it harder for departments to share information and coordinate work. The company needed a system that could support higher business volumes and the traceability expectations of its pharmaceutical customers.
What LeverX did
LeverX helped implement SAP S/4HANA in four phases, starting with finance and then adding procurement, sales, production planning, and document management. Later phases included product lifecycle management (PLM), quality management, plant maintenance, and SAP SuccessFactors for HR processes. This approach allowed Enable Injections to introduce capabilities as the business needed them.
The team also integrated SolidWorks with SAP so engineering teams could manage design data alongside related product information. For document change approvals, LeverX introduced its Integrated Process Solution (IPS), replacing paper-based approval steps with a workflow in SAP. Employees receive email notifications about requests awaiting approval, while teams can track their progress in the system.
Results
Employees can approve document changes within minutes through the IPS workflow, reducing the paper handling previously involved. Teams can also monitor approval progress and identify where requests are delayed.
European pharma companies: Integrating regulatory compliance into batch-release processes
Two European pharmaceutical companies needed to connect regulatory information with their batch-release processes.
Challenge
Teams manually checked information across several systems to identify materials affected by regulatory changes and update related batches. Limited access to regulatory dates and submission versions made it harder to track changes and increased the risk of errors and delays.
What LeverX did
LeverX helped develop and implement SAP Batch Release Hub (BRH) on SAP Business Technology Platform (SAP BTP). The team analyzed business requirements, configured release workflows, and integrated the solution with SAP S/4HANA and external systems.
The solution brought regulatory information and release activities into a shared process. Applications for different user roles gave employees access to relevant tasks and data, while electronic signatures and audit logs supported the recording of release decisions.
Results
Teams gained easier access to regulatory information and performed fewer manual checks across systems. The project helped customers achieve the following outcomes:
- 10–20% lower risk of quality non-compliance.
- 5–50% lower compliance and risk management costs.
- 5–50% shorter order fulfillment lead times.
- 1–25% lower inventory carrying costs.
Optical fiber and laser systems manufacturer: SAP S/4HANA conversion within a three-day window
A global manufacturer of optical fibers and laser delivery systems for medical, industrial, and scientific applications.
Challenge
The company needed to move from SAP ECC to SAP S/4HANA while maintaining its manufacturing operations. The production system could be paused only during a three-day holiday window. Existing custom developments also needed adaptation to work in the new environment.
What LeverX did
LeverX managed the conversion, from infrastructure setup to the production-system transition, using SAP Activate to organize the work. The team applied a brownfield approach, converting the existing system and adapting its custom code. The scope covered finance, production planning, quality management, procurement, sales, and master data governance.
After the conversion, LeverX introduced SAP Production Planning and Detailed Scheduling (SAP PP/DS) to support more detailed production schedules and resource planning.
Results
The transition to SAP S/4HANA was completed within the planned three-day window. The company gained additional production planning capabilities through PP/DS and continued working with LeverX on system support, configuration, and further improvements.
European Chemical Manufacturer: SAP EHS for Safety Management and Reporting
A European chemical group with factories worldwide, producing plastics, synthetic rubber, fertilizers, and other chemical products.
Challenge
The company needed easier access to current hazardous substance data to support safety management and regulatory reporting. Its existing SAP ERP and Environment, Health, and Safety Management (SAP EHSM) environment also needed modernization, including connections to third-party applications.
What LeverX did
LeverX participated in the SAP Environment, Health, and Safety (SAP EHS) implementation and developed SAP Fiori applications for chemical inventories, safety instructions, and chemical data analysis.
The team consolidated environmental permit information and extended functions for compliance requirements, risk assessments, and inspections. It also developed reports supporting specific North American regulations, including SARA Section 302 (extremely hazardous substances), the US Risk Management Program (RMP), and Canada's Environmental Emergency Regulations (E2). These reports allowed employees to monitor hazardous substance quantities and threshold exceedances by site and date.
The work included migrating master data, hazardous substance inventories, and safety instructions from the legacy environment to the SAP S/4HANA data model.
Results
Employees gained easier access to information needed to monitor hazardous substances and assess related risks. Consolidated permit records and reporting applications made it easier to prepare documentation and review site-level data for environmental and safety requirements.
North American Energy Company: Unified Asset Data With SAP Business Data Cloud
A North American energy company operating power plants, distribution networks, and facilities that manufacture and maintain equipment such as turbines and generators.
Challenge
Equipment records, maintenance histories, and operating data were spread across ERP systems, specialist applications, contractor databases, and spreadsheets. Conflicting records made reports harder to trust. Teams spent weeks collecting and reconciling information for maintenance decisions, investment planning, and regulatory reporting.
What LeverX did
LeverX implemented SAP Business Data Cloud (SAP BDC) to bring asset and operational information into a consistent data model. The team connected SAP S/4HANA with equipment sensor platforms, manufacturing systems, and external data sources, then automated data collection, cleansing, and consolidation.
Reports in SAP Analytics Cloud gave managers and engineers a shared view of equipment condition, performance, and maintenance costs. Standardized data also reduced the reconciliation work needed to prepare compliance and audit reports.
Results
- An 80% reduction in data consolidation time.
- Up to a 98% increase in asset data accuracy and reliability.
- 30% faster maintenance and investment decisions.
Where Regulatory Gaps Put SAP Projects at Risk
Regulatory requirements can disrupt an SAP project when the agreed scope leaves out work needed to meet them. The consequences depend on when the gap appears: an early correction may require a configuration change, while a discovery during final testing can force the team to revisit completed work.
Late requirements force redesign
If a mandatory report needs data the planned solution does not capture, the team may have to change data fields, integrations, and reporting logic. Previously completed tests may then need to be repeated. This additional work consumes the time reserved for resolving defects and preparing for launch.
A new rule introduced during the project can have a similar effect. Without an agreed assessment of its impact on scope, resources, and deadlines, the delivery plan no longer reflects the work required.
To avoid this:
- Involve the relevant quality, legal, tax, and privacy specialists before approving the design.
- Document applicable requirements, their effective dates, and the processes and data they affect. Separate mandatory obligations from internal preferences.
- Assess new or changed requirements through project change control, updating the scope, budget, and schedule where necessary.
Custom solutions make later updates harder
A custom solution may address an immediate requirement but create dependencies that complicate subsequent changes. If statutory reporting logic relies on modified SAP code, an update can require developers to review and adapt those modifications before it can be used.
Custom development can follow Clean Core principles. The maintenance risk depends on how the extension is built and how closely it depends on SAP’s internal code. SAP’s extensibility guidance favors stable interfaces to reduce these dependencies.
To avoid this:
- Check whether SAP’s supported localization content and configuration options cover the requirement before commissioning custom development.
- Where an extension is necessary, use supported extension options and stable interfaces appropriate to the SAP edition.
- Document its dependencies and assign responsibility for reviewing and testing it when SAP or regulatory requirements change.
Migration leaves gaps in required records
Transactions may transfer successfully while information needed to interpret them is missing or incorrectly mapped. For example, a migrated record may lose its connection to a relevant approval or historical status.
Where that information supports a regulated process, the company may need to recover it or retain access to the original records. Discovering the gap near launch adds reconciliation and testing work when the schedule has little room left.
To avoid this:
- Identify which records, history, and relationships must remain available, and decide whether to migrate them or retain access elsewhere.
- Include those relationships in migration mapping and trial migrations.
- Have the responsible business specialists check that records remain complete, understandable, and retrievable before accepting the migration.
Testing stops before the full process is complete
Creating a report in SAP does not establish that it can be submitted successfully. Electronic reporting may also depend on a separate service and a connection to an authority’s platform.
If testing excludes submission, rejection handling, and corrections, faults can remain hidden until the company needs to report. Teams may then face urgent fixes or temporary manual workarounds.
To avoid this:
- Define tests that cover the complete reporting process, from source data through submission and confirmation.
- Test rejected submissions, corrections, and failed connections as well as successful processing, using the authority’s test environment where available.
- Assign responsibility for monitoring submissions and resolving failures, and verify that the relevant employees can perform these tasks before launch.
How to Assess a Partner’s Regulated-Industry Case Study
A relevant case study should connect the customer’s regulatory obligations with the work the partner delivered. An industry label alone gives little basis for comparison: two pharmaceutical projects, for example, may involve very different processes, systems, and responsibilities.
Identify the requirements behind the project
Look for the specific obligations that shaped the scope and how the solution addressed them. A broad claim such as “improved compliance” leaves those connections unclear.
The partner’s role also matters. Developing an approval workflow, integrating regulatory data, and preparing validation evidence represent different contributions. The case should make clear which work the partner performed.
Check what testing and validation established
Where validation applies, useful evidence links requirements to tests, acceptance criteria, and documented results. This helps explain what the team checked and why the customer accepted the system for use.
Compare the case with the partner’s credentials and proposed team
SAP Partner Finder provides competency and specialization information to help assess a partner’s solution expertise and delivery experience. Use it alongside the case study and the experience of the people proposed for your project. These credentials support the assessment; they do not certify compliance with your regulatory requirements.
|
Evaluation area |
Green flags |
Red flags |
|
Regulatory scope |
Names the applicable requirements and explains how they affected the solution. |
Claims to “ensure compliance” without identifying the requirements or controls involved. |
|
Partner’s contribution |
Clearly separates the partner’s work from the customer’s responsibilities and other suppliers’ contributions. |
Describes the overall project without explaining what the partner delivered. |
|
Architecture and extensions |
Explains why extensions were needed and how they will be maintained through SAP updates. |
Presents extensive customization as an achievement without addressing maintenance or upgrade dependencies. |
|
Data migration |
Describes reconciliation checks and how required history and relationships between records remained accessible. |
Claims “zero data loss” without explaining what was checked or how discrepancies were resolved. |
|
Results |
Reports specific outcomes with enough context to understand what changed. |
Uses broad claims or percentages without defining the measure or comparison. |
|
Credentials and team |
Relevant SAP competencies support the case, and the proposed team can explain comparable delivery experience. |
Relies on general partner status while providing little evidence of relevant experience in the proposed team. |
A missing detail in a public case study is a reason to ask a follow-up question. The stronger warning sign is a partner that cannot explain its approach or substantiate its claims within confidentiality limits.
Plan Your SAP Transformation With LeverX
LeverX brings experience from pharmaceutical, medical device, chemical, and energy projects to help you turn these requirements into a practical delivery plan.
We can support your team with:
- SAP implementation and migration: We help you define the scope, adapt existing developments, and plan the transition around production schedules and available downtime.
- Process improvements and integrations: Our team can connect approval workflows, quality processes, regulatory information, and external systems to reduce manual checks and duplicate work.
- Data migration and reporting: The LeverX experts consolidate fragmented information and verify that required records and relationships remain accessible.
- Testing and ongoing support: We work with your business and quality teams to test critical processes, resolve issues, and maintain the solution as requirements change.
Whether you are planning a full SAP S/4HANA transition or improving a specific process, we can help define what the project requires, which dependencies affect delivery, and where a phased approach makes sense.
Discuss your project with LeverX to identify the scope, priorities, and next steps for your SAP transformation.
FAQ
One challenge is balancing global process standards with local requirements. Tax rules, statutory reporting, and industry regulations can differ between countries, so a global SAP template may need local adjustments. If these requirements are identified too late, teams may have to revisit configurations and repeat testing.
Another risk comes from allowing too many exceptions to the global template. Country-specific changes may solve immediate problems but increase maintenance and complicate future rollouts. Each exception needs a clear business or regulatory justification.
Responsibilities can also become unclear when global IT, local business teams, and implementation partners work across several countries. Without agreed decision-making authority, local requirements may remain unresolved until they delay the rollout. Cutover planning adds another challenge: production schedules, public holidays, and regulatory constraints can leave different sites with very different windows for switching systems.
Specialist SAP partners like LeverX have experience in industries such as pharmaceuticals, chemicals, and energy, while large integrators including Accenture, Deloitte, IBM, and Capgemini deliver global SAP programs.
To assess their experience, look beyond the number of completed projects. Ask how many countries and SAP systems were involved, how the partner handled complex integrations, and what volume of historical and transactional data had to be migrated. References should also show measurable results, such as cutover duration, post-go-live system stability, or the number of sites successfully brought onto the new platform. Ideally, these examples should come from projects with a similar scale and regulatory complexity to yours.
How useful was this article?
Thanks for your feedback!
