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U.S. Food and Drug Administration (FDA) Title 21 Code of Federal Regulations (CFR) Part 11

Assessments of SAP Products

For information about the U.S. Food and Drug Administration and Regulations in general, see the U.S. Food and Drug Administration and Regulations. For details about U.S. FDA Title 21 CFR Part 11, see the U.S. FDA Title 21 CFR Part 11 Regulation.

The U.S. FDA Title 21 CFR Part 11 Regulation regulates the use of computerized solutions and processes within Good Clinical, Laboratory and Manufacturing Practices (GxP) relevant areas within the Life Sciences industries. From a software aspect it comprises the areas of security, audit trail and digital signature. The documents available here investigate the various SAP solutions and applications on these compliance aspects of the Part 11 regulation.

Another important aspect of Part 11 is validation: Life Sciences companies must prove for GxP relevant areas and processes that their computerized solutions or processes really work as they are determined to work. If there are changes in the computerized system it has to be revalidated.

As a software provider, SAP cannot deliver "validated software" because the processes are very individual in each and every company and therefore these aspects are not considered in the documents listed here. Therefore, SAP ships qualified software according to ISO 9001:2000. And how SAP software complies with the Part 11 rule is explained in these documents.

U.S. FDA Title 21 CFR Part 11 Compliance Assessments of SAP Business Suite Components and Applications

UPDATE Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry  (updated January 8, 2013)
Find out how SAP software complies with U.S. FDA Title 21 CFR Part 11 regulations for life sciences companies. See how it helps manage compliance for enterprise assets, enterprise quality, manufacturing execution and electronic batch records, qualifications (training), warehouses.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Learning Solution  
Get detailed information on how SAP Learning Solution demonstrates technical compliance with the FDA Title 21 CFR Part 11. Learn about the related functions of SAP Learning Solution, such as security, e-records, and digital signature, and how they comply with specific clauses of 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Recipe Management  
Consider how SAP software complies with the U.S. FDA Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) regulations. SAP software addresses the regulations in terms of recipe management. Investigate why SAP believes that the recipe management software in the SAP ERP application fully complies with 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Environment, Heatlh & Safety  
Discover how the SAP Environment, Health & Safety (SAP EH&S) application fully complies with the FDA Title 21 CFR Part 11 rule of the U.S. Food and Drug Administration. Learn about the related functions of SAP EH&S and how they comply with specific clauses of FDA Title 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of the Interaction Center (IC) of SAP CRM  
Read how the FDA Title 21 CFR Part 11 Compliance Assessment of the Interaction Center (IC) of SAP CRM demonstrates technical compliance with U.S. FDA requirements - through background information and examples of electronic records and signatures.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Supplier Relationship Management 5.0  
Get detailed information on how the SAP Supplier Relationship Management (SAP SRM) application demonstrates technical compliance with the requirements for software performance set forth by the U.S. Food and Drug Administration in U.S. FDA Title 21 CFR Part 11 rule.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Supplier Relationship Management 4.0  
Get detailed information on how the SAP Supplier Relationship Management (SAP SRM)4.0 application demonstrates technical compliance with the requirements for software performance set forth by the U.S. Food and Drug Administration in U.S. FDA Title 21 CFR Part 11 rule.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Document Management and SAP Easy Document Management  
Discover how the SAP Easy Document Management System (SAP Easy DMS) and SAP Document Management System (SAP DMS) application fully comply with the FDA Title 21 CFR Part 11 rule of the U.S. Food and Drug Administration. Learn about the related functions of SAP Easy DMS and SAP DMS and how they comply with specific clauses of FDA Title 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management  
Get detailed information on how SAP Records Management demonstrates technical compliance with the FDA Title 21 CFR Part 11. Learn about the related functions of SAP Records Management, such as security, e-records, and digital signature, and how they comply with specific clauses of 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Collaboration Folders 
Read how the FDA Title 21 CFR Part 11 Compliance Assessment of SAP Collaboration Folders demonstrates technical compliance with U.S. FDA requirements - through background information and examples of electronic records and signatures.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP CRM Sales and Field Sales  
Get detailed information on how SAP CRM Sales and Field Sales demonstrate technical compliance with the FDA Title 21 CFR Part 11. Learn about the related functions of SAP CRM Sales and Field Sales, such as security, e-records, and digital signature, and how they comply with specific clauses of 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessments of SAP NetWeaver Components and Applications

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP NetWeaver  
This white paper explains how SAP NetWeaver complies with the U.S. FDA Title 21 CFR Part 11 regulation and how it builds the security foundation for the components and applications based upon SAP NetWeaver.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP NetWeaver Business Intelligence  
Read how the U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP NetWeaver Business Intelligence demonstrates technical compliance with U.S. FDA requirements - through background information and examples of electronic records and signatures.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP NetWeaver Exchange Infrastructure  
Review how the SAP NetWeaver Exchange Infrastructure (SAP NetWeaver XI) component and the SAP NetWeaver technology platform technically comply with the intent and requirements of U.S. FDA 21 CFR Part 11 for security, electronic records, and archiving.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP NetWeaver Portal  
Review how the SAP NetWeaver Portal component demonstrates technical compliance with U.S. FDA requirements for security, electronic records, and digital signatures - through background information and examples of electronic records and signatures.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP NetWeaver Audit Management  
Read detailed information on the SAP NetWeaver technology platform's audit management functionality's compliance with requirements for performance set forth by the U.S. Food and Drug Administration in U.S. FDA Title 21 CFR Part 11 rule. Audit management functionality is available in all SAP solutions based on SAP NetWeaver.

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Solution Manager  
Get detailed information on how SAP Solution Manager 3.2/4.0 demonstrates technical compliance with the FDA Title 21 CFR Part 11. Learn about the related functions of SAP Solution Manager, such as security, e-records, and digital signature, and how they comply with specific clauses of 21 CFR Part 11.

U.S. FDA Title 21 CFR Part 11 Compliance Assessments of SAP NetWeaver Components and Applications of SAP NetWeaver Mobile 7.1  
Get detailed information on how the SAP NetWeaver Mobile 7.1 application demonstrates technical compliance with the requirements for software performance set forth by the U.S. Food and Drug Administration in U.S. FDA Title 21 CFR Part 11 rule.

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