What is SAP GxP?

SAP systems are suitable for numerous sectors - including the life sciences industry. They help companies there to fulfil the strict GxP requirements.

Among other things, real-time data from production is automatically collected, analysed and documented. This reduces risks and increases efficiency.

The term SAP GxP refers to the use of SAP software in regulated industries. These include, in particular, the pharmaceutical, medical technology and biotechnology industries (also known as the life sciences industry).

In these industries, very specific and strict regulatory requirements apply to products - and therefore also to the processes and systems used to manufacture them.

SAP GxP includes functions that enable companies to fulfil these requirements. Issues such as data security, traceability and documentation play an important role here.

The abbreviation GxP is a collective term for various regulatory requirements that apply in medicine, pharmacy and pharmaceutical chemistry.

• The letters ‘G’ and “P” stand for ‘Good Practice’.
• The ‘x’ is a placeholder for several areas (see next section).

The best way to translate ‘good practice’ is ‘good working practice’ or ‘good practices’.

The corresponding guidelines - such as FDA 21 CFR Part 11 and EU GMP Annex 11 - are internationally recognised. They are monitored by authorities such as the FDA (Food and Drug Administration, USA) and the EMA (European Medicines Agency, EU). Their aim is to ensure a high level of quality and compliance of products and processes.

Several GxP guidelines apply in the pharmaceutical and biotechnology industry. The most important guidelines are as follows:

• Good Manufacturing Practice (GMP): GMP regulates the manufacture of products to ensure quality, efficacy and safety
• Good Laboratory Practice (GLP): GLP regulates the conduct of non-clinical studies to ensure reliable and meaningful study results
• Good Clinical Practice (GCP): GCP regulates the conduct of studies in humans to ensure the rights, safety and well-being of participants and to ensure reliable, meaningful study results
• Good Distribution Practice (GDP): GDP regulates the distribution of products to ensure their quality and integrity during transport

These and several other GxP guidelines ensure that medicinal products, medical devices and other related products are safe and effective.

The main difference between GxP and non-GxP lies in the requirements placed on the processes and systems.

For example, GxP-compliant systems must have special properties in terms of data integrity, security and traceability. GxP environments are characterized, for example, by

• Seamless documentation of processes
• Audit trails for the traceability of changes
• Data validation in accordance with CSV (Computerized System Validation)
• User rights management to secure processes

Non-GxP systems are not subject to these strict regulations. Accordingly, they are used in less critical industries in which no legal compliance requirements apply.

SAP S/4HANA Cloud for GxP, Private Edition is a version of SAP S/4HANA specially developed for regulated industries. The platform makes it possible to map business processes in a validatable environment without having to forego the advantages of a cloud solution.

The special features of SAP S/4HANA Cloud for GxP, Private Edition are:

• GxP-compliant solution with validatable processes
• Compliance with regulatory requirements thanks to industry-specific features
• Private cloud environment for maximum control and data security
• SAP Business Technology Platform (BTP) integration for extended services (see next section)

The SAP S/4HANA Cloud for GxP, Private Edition is particularly relevant for pharmaceutical companies, medical technology manufacturers and life sciences companies.

In general, the SAP Business Technology Platform (BTP) is used to extend the standard functional scope of SAP S/4HANA in the cloud. This is relevant, for example, for implementing industry-specific and individual requirements. The BTP is also used to integrate third-party systems. It provides a range of special services and functions for GxP environments. These include

• Data management and audit trails to ensure data integrity and product traceability
• Automated workflows for validation and compliance with GxP specifications
• Real-time analyses for monitoring production processes (including AI support)
• Integrations for GxP-relevant systems and applications

In addition, the SAP Business Technology Platform is a highly secure cloud environment. It can therefore be used without hesitation in the GxP environment.

Yes, SAP is ISO-certified. This means that the software provider meets international standards for quality management and information security.

The certifications include ISO 9001 (quality management) and ISO 27001 (information security management). These certifications prove, among other things, that SAP meets the high requirements for security and compliance in GxP environments.

SAP provides companies in GxP-regulated industries with a range of tools and services. These help companies to comply with legal requirements more easily.

First of all, modern SAP systems (especially SAP S/4HANA and SAP BTP) support Computerized System Validation (CSV). This is a verification process that can be used to check whether computerized systems are working reliably and meet regulatory requirements.

SAP also enables reports to be generated automatically. This is particularly important for audits and inspections by authorities. SAP software also ensures the traceability of all data and processes. This feature is extremely important in the event of audits and product recalls, for example.

SAP also has integrated security mechanisms for data control. The systems can also be flexibly adapted to regulatory changes. Last but not least, SAP supports the live monitoring and documentation of manufacturing processes through the integration of production data (see next section). This significantly reduces the manual monitoring and documentation effort.

SAP enables real-time monitoring and documentation of production processes through the integration of modern technologies. These include, above all, the IoT (Internet of Things) and advanced analytics.

The IoT is responsible for data collection and provision. Advanced analytics can continuously monitor this data and immediately detect deviations from the norm. For example, errors in the production of a medicine can be identified and rectified immediately. SAP software also ensures that the data from the production processes is automatically documented.

In addition to modern technologies, SAP offers a range of training courses and know-how resources to support companies in the GxP environment.

These include, for example, the “Life Sciences Learning Journey”, which provides information on the targeted use of SAP solutions in the GxP environment. Training courses on switching from SAP ECC to SAP S/4HANA and Intelligent Enterprise are also included here.

Companies can also access various consulting services and support relating to the GxP solutions. Corresponding services are provided both by SAP itself and by SAP partners.

SAP GxP has several advantages for companies in regulated industries. The most important points are

• Reduction of manual effort through a high degree of automation of GxP-related processes
• Significant reduction in internal compliance costs while improving GxP conformity at the same time
• Risk minimization through complete traceability and documentation of data
• Quick adaptation to changes in GxP requirements thanks to a flexible compliance framework
• Short-term audit readiness through documentation of GxP relevance and risk assessment at transaction, field and data object level