Professional Documents
Culture Documents
Presented to : Korean
Presented by :
______________________
(Source : BCC, Inc. "World Pharmaceutical Markets" 2004) Estimated US $ 900 Billion in 2010
Software compliance requirements for the above are the key features of SAP Best practices and Pharmavision
FDA's Standards for the use of electronic records and signatures as an equivalent and/or substitute for paper records and handwritten signatures executed on paper
21CFR, part 210
FDA's Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs; general
21 CFR, part 211
Examples of E-records
Batch Records ( Manufacturing records) Compliance Records ( Validation IQ / OQ / PQ Protocols) Laboratory data ( Routine inspection, Stability sample management) Manufacturing data (Master formulation record, Master Packaging record) Training records ( cGMP 21 CFR Part 210, 211 and Part 11) Calibration tracking records ( Laboratory equipments ) Audit trails ( Deviations listing, Resource logs)
Concept of Use
SAP Best Practices: Installation Quick Installation SAP Best Practices Tools
Preconfigured Business Scenarios Benefits of SAP Best Practices cGMP compliance in the GMP relevant functional modules
Enable fast and easy implementaWorking prototype tion of mySAP Business Suite With SAP Best Practices Demonstration of a solution that is easy to:
identify
Documentation
BP Scenario overview BP Business process procedures Installation instruction
Preconfiguration
Preconfiguration settings Master data Configuration Documentation Installation Assistant
SAP GMP Relevant modules for 21 CFR Part 210 and 211
Quality management (QM Module) Warehouse management (WM Module)
Other SAP GMP Relevant modules for 21 CFR Part 210 Compliance
Plant Maintenance (Instrument calibrations and Equipment history) Project Systems (R&D Projects) APO (Batch recall network)
Accounting Document
Accounts Receivable
Accounts Payable
Vendor
Asset Management
Pharmavision
What is Pharmavision ?
+
SOLTIUS Pharma Expertise
Add-ons
Pre-configured Features
Enhanced Features Custom Features
Pharmavision
Features - Pharmavision ?
Enhanced and Custom features Enhanced Change Management Enhanced Quality control
Manufacture at risk
Quality status label management Batch re-work process Pipe line material Inspection Audit Trails
Ship on hold
Custom inventory movements Manufacturers part control Custom reports Batch classification
User Acceptance/Integration Testing Protocol User related application SOPs templates 21 CFR part II validation protocol for Digital signatures Rigorous Change Control And Problem Reporting
Pharmavision has been customized to Paddock's needs and addresses the company's core business process and key manufacturing areas;
Procurement and Sales and Distribution Inventory Management and Warehouse Management Process Manufacturing and Quality Management Finance, Profitability Analysis and Reporting ASP plus Hosting is powered by AT&T's Ecosystem
A provider of specialty respiratory, cough/cold, pediatric and central nervous system products and anti cancer drugs maintains a manufacturing facility in Indonesia Pharmavision has been implemented to the company's core business process and key manufacturing areas, the company went live in July 2002: Combiphars financials, order management, procurement, inventory management, batch management and lot trace ability, quality management, distribution, custom Warehouse management solutions and localized Legal requirements were customized in the Pharmavision Effectively employed the solution in only six months
Wyeth Labs
Johnson & Johnson Eli Lily
PT. Combiphar
Siemens Medical Systems EnMed
Purdue Pharmaceuticals
Med Pointe
Dade Behring
Electronic Signatures
Custom Reports
Questions?