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.
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U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management
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U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Easy DMS and SAP DMS
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.
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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.
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U.S. FDA Title 21 CFR Part 11 Compliance Assessment 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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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.
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Annual Product Review Process for Pharmaceutical Industry – Part One
For the Life Sciences Industry, Annual Product Review (APR) is an important part of the overall regulatory compliance process. This article provides an overview about APR and typical challenges faced by the customers. It also shares the experiences from a collaboration project between SAP ES Community and Intelligroup, where APR Community Definition Group (CDG) was formed as part of this initiative and multiple work packages were defined and validated by customers as part of this innovation project.
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Quick Guide: How Channel Partners build Business All-in-One Solutions?
This paper elucidates the salient features on how the SAP and its Channel partners together develop the vertical solutions for the SMB segment. These vertical solutions that have been put up by the Channel partners and SAP together transform into a “SAP Business All-in-One solutions”.The paper also shares the experience of Intelligroup that demonstrated its expertise in building a SAP All-in-One solution for Live Stock industry vertical.
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V Model & Validation Process in the Pharmaceutical Industry - FDA Perspective
The objective of this paper is share Conceptual clarity while working on Life science SAP projects ( nd to end, Solution Rollout, Development & Support etc) and try to take best practices out of this to other domain projects while emphasizing the the importance of validation and compliance from quality system point of view.
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Life Sciences Use Cases for SAP HANA
Learn how SAP HANA addresses big data needs in detail. This space should inform you about current use cases. 
To find more details about how HANA can support the Life Sciences industry click on the use case headline.
Traditionally Genome Analysis takes 2 days. By using cloud-based genome analytics from MKI in combination with SAP HANA it is possible to reduce the time to 20 minutes.
So more DNA could be analyzed and more patients could be helped.
This use case describes 3 steps which are needed in the Genome Analysis with MKI and further more it allows a deeper inside via videos and blogs.
View more Life Sciences use cases...
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SAP HANA Life Sciences Use Cases
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Smart Tab Integration with SAP for Pharmaceutical Bulk Vessel Capacity Planning
Abstract
Lots of theories and strategies revolve around optimum utilization of manufacturing capacities. Methodology working for a certain production line may not work for other lines because of product nature, skills etc. This POC is presented to get 360o view of capacities in an enterprise.This will provide details such as available and utilized capacities, Resource (Vessel) breakdown, maintenance history, production history, yield and vessel compatible details and many more which I left for imagination.
Manufacturing Capacities
Visibility of available capacity is prime criteria for better utilization of vessel capacities. Product loading becomes easier when planner knows what capacity is available and how much he has to load.
Capacity planning which involves maintaining data, scheduling and leveling, can be best performed with complete details of available capacity for a product range. Available capacity should be calculated after excluding breaks, maintenance time and preventive maintenance. And at any instance a 10% buffer is good to maintain to tackle contingency.
In process industries, we often find a relation between yield and a particular resource usage (may be chemical kinetics and vessel dynamics help in getting better yields). Though capacity and make of the vessels used in producing a particular batch remains same, in one case yield would be better than other (Considering all other variables and parameters are equally monitored).
It becomes inevitable to avoid these kind of information.
Maintenance of the resources helps avoiding frequent breakdowns and improving asset life. Maintenance engineer needs to keep information of resources which has to be overhauled without disturbing production.
Considering above requirements, we are bound to have complete details of resource.
There are various applications to capture and provide this information, but here we have designed an Ipad application which will integrate with SAP system as well as resource.
Resource start and stop will be performed using Ipad which in turn captures information of resource usage. Ipad application will interact with SAP systems to provide order schedule and resource loading information.
Order Master
Order Master provides complete details of orders to be executed at a particular resource on any day.
You need to select operations of a particular order and press start button to run the resource. System will capture the start and end times with this interface.
Also the this data is transferred to SAP to provide information of usage of resource and availability real time.
Smart Tab Enterprise Apps
Resource 360
This application will provide complete details of resource as well as resource history for analysis. Following details are available but not limited
Available capacity Maintenance History
Capacity Utilization Product Capacity History
Break down Yield Information
Integration Architecture
In SAP we maintain Resource and capacity data. After performing MRP planner has to publish order schedule. This schedule will be fetched by Ipad application to process order and resource schedule.
*Logos and organization names used in this document are information purpose only
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Pharma 101
Hallo,
I have seen quite some high level questions about processes in Pharma and how SAP can cover those. As it is very difficult to answer those questions in a single Q&A thread in SCN I would like to point out 2 things. First check out the blogs and documents tagged "pharma-for-beginners". Those provide a high level intro into the Pharma Industry. Second, check SAP Best Practices for Pharmaceuticals. This is a collection of documents that shall support the fast implementation of ERP in a pharmaceutical environment.
Using all the documents incl. the master data files would allow to build an entire ERP system with all the data required and running the pre-defined sample processes. But for starters the documents provide a great overview on business processes in Pharma.
Here is how you get to this content: Go to http://help.sap.com, select "SAP Best Practices", expand the "Industry Packages" branch and click on "Pharmaceuticals". There you'll find a section with the "SAP Best Practices for Pharmaceuticals" package in the latest version. Click on the language link to open the content.
This is the direct Link but this may change with the next version: http://help.sap.com/saap/sap_bp/baio_frame/PH_ERP606_EN_US.html
I hope this helps.
Oliver
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Integrate Contract Lifecycle and Revenue Management
Used in conjunction with the SAP® ERP application, the SAP Paybacks and Chargebacks and the SAP Incentive Administration applications by Vistex and the SAP Data Maintenance application for ERP by Vistex offer a complete, innovative solution for contract lifecycle and revenue management. With fewer costly interfaces to maintain, you can minimize operating costs. And by eliminating excessive payments and streamlining your contract management processes, you can sharpen your competitive edge.
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Complying with Global Electronic Records/Signatures (ERES) Regulations in the Life Sciences Industry
Learn how your life sciences company can leverage your SAP ERP application infrastructure to improve your level of regulatory compliance and significantly reduce costs. Discover how SAP ERP supports technical compliance with global electronic record and electronic signature (ERES) regulations.
Please download the White Paper via following link:
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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
- 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 Assessments of SAP Business Suite Components and Applications
UPDATEComplying 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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Case study CareFusion: Real-Time Business Leads to Healthy Performance
This Bloomberg case study shows how CareFusion employs in-memory computing to transform its business, improve operating margins and accelerate revenue growth.
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Varian Harmonizes Systems to Help Save Lifes
This case study shows how Varian Medical accelerates innovation through lean, paperless product design and optimizing manufacturing processes for compliance-sensitive products.
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