Life sciences organizations must deal with a broad range of industry-specific regulatory issues in addition to standard corporate governance, risk, and compliance demands. In fact, regulatory compliance is a core part of your business, ensuring a competitive supply chain, promoting customer confidence, and enabling profitable growth.

SAP solutions for governance, risk, and compliance (GRC) support the requirements of life sciences organizations to manage risk across the enterprise, increase business performance, and drive competitive advantage. Life sciences companies are specifically challenged to address risk across their core business areas that include: finance, operations, environment, and global trade. To meet these objectives and ensure corporate sustainability, SAP solutions for GRC unify corporate strategy, risk management, and control initiatives across the extended enterprise.

Electronic Records and Signatures

With SAP solutions, you have the functionality you need to comply with regulations and guidelines related to electronic records and signatures, including:

• EU Directive 91/356 (EU GMP Guideline) – This directive specifies legal requirements for good manufacturing practice (GMP) in the European Union (EU). It requires that data be available at the proper time, provided in a readable form, and protected against damage or loss.
• ICH Q7A Guideline – International Conference on Harmonization (ICH) Q7A provides guidelines for active pharmaceutical ingredients in the EU, the United States, and Japan.
• PIC/S – The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) provide guidance on pharmaceutical inspections.
• Title 21 CFR Part 11 – This U.S. FDA regulation establishes requirements for electronic records systems, regulating the use of computer systems, audit trails, lot and serial traceability, change control, archiving, e-signatures, and security.

Radio-Frequency Identification

SAP solutions provide capabilities that enable compliance with regulations and guidelines related to radio-frequency identification (RFID), including:

• FDA Bar Code Label Requirements for Human Drug Products and Biological Products – The FDA requires bar codes on most prescription drugs and certain over-the-counter drugs.
• Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects – The European Commission has established procedures for the rapid transmission of information related to pharmaceutical recalls.
• Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs – This FDA Compliance Policy Guide describes how the FDA intends to enforce regulations related to labeling, electronic records, and product quality for pharmaceutical manufacturers, repackers, relabelers, distributors, and retailers.
• U.S. state regulations – Several states are establishing mandates that require pharmaceutical wholesalers and distributors to maintain pedigrees for every drug shipped.

SAP addresses the regulatory requirements of the life sciences industry through SAP solutions for GRC, SAP ERP, and the SAP NetWeaver platform, which provide functionality and support for financial, environmental, and operational risks; advanced security; audit trails; digital signatures; RFID technology; and more.