How SAP for pharmaceutical companies ensures GxP compliance

Even with SAP systems in place for pharmaceutical companies, achieving and maintaining GxP compliance (Good Manufacturing, Laboratory, Clinical Practices, etc.) remains a considerable challenge. Material and supplier master data in SAP form the backbone of production and quality processes, and any error or lack of control in their management can compromise data integrity and regulatory compliance. In particular, SAP’s standard management does not always provide sufficient mechanisms to ensure the traceability, accuracy, and validation required by GxP standards, leaving companies exposed to failed audits or operational inefficiencies.

Below, we examine the most common challenges faced by pharmaceutical companies when operating with standard SAP, and how these can jeopardize GxP compliance. We will then explore how specialized solutions add layers of control and quality to SAP.

Common Challenges When Operating with Standard SAP in Pharmaceutical Companies

• Incomplete or unvalidated information in master data: In a GxP environment, materials and vendors must have complete and consistent data (regulatory codes, units of measure, stability data, licenses, tax information, etc.). Standard SAP for the pharmaceutical industry allows the creation of records with critical fields left blank, incorrect formats, or invalid combinations, as it does not enforce the completion of all information or verify its consistency. This undermines the data integrity required by GxP and propagates errors across multiple processes.

• Manual errors in sensitive data: When information is gathered via spreadsheets or emails and manually transcribed into SAP, the risk of errors in sensitive fields increases: payment terms, IBAN, tax data, etc. A single misplaced digit can result in failed payments, financial deviations, or contractual breaches that are hard to trace. In pharma, such SAP failures can become audit findings that compromise the company.

• Scattered documentation with no version control: Certificates of analysis, licenses, specifications, and critical documents are often dispersed across emails, shared folders, or physical files. This makes it difficult to identify the current version, increases the risk of using outdated documents, and complicates compliance demonstrations during inspections. In industries such as pharmaceuticals, it is essential that SAP provides a central repository with version control to ensure work is always done with the latest approved revision.

• Lack of clear traceability in record modifications: Any significant change in master data must be fully traceable (who, when, what, and why). With standard SAP, this traceability depends on technical logs that are hard to access, making it difficult to comply with regulation requirements.

• Non-auditable, decentralized approval processes: The creation or modification of materials and vendors involves multiple departments that must approve the information (Regulatory, Quality, Purchasing, Finance, etc.). Standard SAP does not offer an integrated approval workflow for these processes, so they are managed through emails or informal conversations. This results in a lack of formal evidence, control gaps, and difficulty auditing the GxP governance process.

• Risk of duplicate materials or vendors: Without preventive controls, different users can create duplicate records for the same material or supplier. This leads to fragmented purchases, split inventories, inconsistent documentation, and loss of traceability. From a GxP perspective, a duplicate can mean working with an unqualified supplier or complicating investigations in the event of a product recall. Correcting these duplicates requires costly cleanups and complex justifications during audits.

The Solution to Ensure GxP Compliance in SAP Systems for the Pharmaceutical Industry

Overcoming the challenges described above and ensuring GxP compliance is possible by implementing specialized master data quality tools that complement SAP. At Innova, we have developed two solutions to address these types of issues:

• SiDM Materials for managing material master data
• SiDM Vendors for managing supplier master data

These solutions add an extra layer of control, validation, and traceability on top of the SAP system, enabling stronger master data governance aligned with internal policies and regulatory expectations, with minimal custom development. Below are some of the key features these solutions offer to support GxP compliance requirements in SAP environments for pharmaceutical companies:

Customized Forms with Configurable Validation

Master data management solutions provide customized forms for the creation and maintenance of materials or vendors, replacing SAP’s generic transactions with interfaces tailored to the pharmaceutical business. Each form can be configured with mandatory fields, dropdown lists, and specific input rules, so that the user can only submit the request if all critical information is complete and verified.

For example, when registering a new excipient, the form can require the GMP quality code and automatically validate its format. These automatic validations—defined as business rules—act in real time, preventing common errors before data is saved in SAP. The result is a correct master record from the start, requiring no later corrections and posing no compliance risk due to incomplete data.

Business Rules for Critical Data

An essential feature to ensure GxP data quality is the implementation of configurable business rules on critical master data fields. These rules allow the establishment of logical checks that standard SAP does not support.

For example, the tool can verify that a supplier’s tax identification number has the correct format and is not duplicated in the system or validate that the provided bank code matches the supplier’s country. More complex rules can also be defined, such as auto-filling certain data based on others (e.g., inferring the country from the address) or ensuring that a finished pharmaceutical material has at least one active ingredient assigned in its record.

By applying these business rules, the solution ensures that no inconsistent or incomplete data enters the master data.

Full Audit Trail with User-Based History

To meet GxP traceability requirements, these solutions thoroughly log every change made to master data, maintaining a detailed history by user, date, and action.

Unlike SAP’s standard log, which is often difficult to access and limited to certain fields, these tools allow users to easily see which fields were modified and from which value to which. More importantly, they show who requested the change and why.

For example, if the potency of an active ingredient in a material is updated, the system will record which user made the change, who requested it, who approved it, and the reason for the change.

This complete traceability helps fulfill data integrity principles (attributing each action to a responsible person) and addresses one of the most scrutinized points in GxP audits: the existence of robust audit trails for all relevant electronic data.

Approval Workflows with Defined Roles and Release Strategies

Another key component is the integration of approval workflows directly into SAP, ensuring the participation and authorization of the relevant departments before any master data becomes effective.

These solutions allow the design of multi-step approval circuits, assigning separate roles for request, review, and final approval, thereby complying with the principle of segregation of duties.

All steps take place within the tool. As a result, no critical data becomes active without the corresponding approvals, and each approval is recorded in an auditable manner.

Additionally, the workflow can be configured with automatic notifications and conditions (e.g., routing to a different approver if the supplier is for APIs vs. packaging materials).

With these centralized workflows, pharmaceutical companies using SAP eliminate reliance on emails or calls for master data approvals and ensure a repeatable and transparent process aligned with audit expectations and GxP best practices.

Managed Attachments in External Document Repositories (e.g., SharePoint, Azure, AWS S3) with Access Traceability

SAP solutions for the pharmaceutical industry integrate document attachment management securely and centrally. Instead of storing files in SAP (which, by the way, incurs a storage cost), related documentation (GMP certificates, declarations of conformity, technical sheets, etc.) can be stored in certified external repositories like SharePoint, Azure, or AWS S3, which comply with integrity and security standards. This provides several GxP benefits:

• Documents are linked to the corresponding master data (material or vendor) but reside in a robust document management system, access traceability, and backups. For example, if a manufacturer’s licence is attached to its vendor record, it is always accessible from SAP, even if it is stored in one of the repositories.
• During an audit, it can be demonstrated that all documentary evidence (e.g., certificates of analysis, quality agreements) is centralized and up-to-date, eliminating concerns about missing or outdated documentation.
• Connecting to external repositories frees SAP from storing large files while maintaining references within the process.

Duplicate Detection by Key Fields

To avoid the proliferation of duplicate records—one of the issues mentioned earlier—these solutions incorporate real-time duplicate detection engines.

When a new material or supplier registration is submitted, the system compares key fields against existing records: names, tax IDs (NIF/CIF), global codes (EAN, GTIN), or other unique identifiers.

If potential matches are found, the system alerts the user and can even block the creation of the duplicate before it reaches SAP. Thanks to this feature, a costly issue is prevented at the source, keeping the master database clean and reliable.

Early duplicate detection supports both efficiency (avoiding duplicated efforts and confusion in logistics processes) and GxP compliance by ensuring that each entity (material, customer, supplier) has a single, complete, and approved record.

Differentiated Workflows by Material or Supplier Type

Another relevant aspect—especially familiar to those with SAP experience in industries like pharmaceuticals—is that not all master data requires the same treatment.

To address this, SiDM Materials and SiDM Vendors allow the configuration of specific workflows and forms based on material or supplier category. In the pharmaceutical industry, this is particularly useful: registering an API supplier is not the same as registering a packaging material supplier.

With a solution like those offered by Innova, different data models and validation steps can be defined based on type. For example, international vendors may be required to provide additional banking information and import certificates, while local vendors might follow a simpler process.

Similarly, different types of materials can trigger different approval workflows: a new drug might require Regulatory and QA approval, while an office supply might only need Purchasing’s approval.

This workflow flexibility ensures that each master data creation or change follows the appropriate process for its criticality, complying with applicable regulations without slowing down less critical processes.

Native Integration with SAP ECC or S/4HANA, Minimal Custom Development Required

A decisive factor in the success of these solutions is their native integration with SAP, without relying on custom developments or manual synchronization processes.

Applications like SiDM Materials and SiDM Vendors connect directly to the ERP (whether SAP ECC or S/4HANA), using the same business validations and permissions as the standard system, while extending its capabilities.
This means users handle all requests and approvals in the tool’s user-friendly interface, but at the end of the workflow, the data is created or updated in SAP automatically, consistently, and securely.

Managing master data in SAP for pharmaceutical companies with the rigor required by GxP standards is a challenge that should not be underestimated: tools like Innova’s SiDM provide intelligent forms, business rules, audit trails, and workflows that strengthen data quality from the source.

By adopting these types of complementary solutions, companies in the pharmaceutical sector can transform their master data management into a proactive, controlled, and transparent process—aligned with data integrity principles and ready to pass any inspection.