RasmusRud.com suppliergoodpracise.com qualitypharmaprocess.com
Supplier Good Practices
Advice suppliers of GxP computerized systems, based on ISPE GAMP5, to execute projects in a good modularised and staged practical way.
1. Develop products based on practical interpretation of ISPE GAMP5, industrial experience and lean execution.
2. Share products support Supplier Good Practices.
3. Support with implementation and change management.
Products:
- Training ISPE GAMP5.
- Levage of supplier knowledge – expectation to suppliers.
- ISPE GAMP5 - quality risk management
- ISPE GAMP5 - Stage Gate project risk management
- Supplier Quality Plan SQP - description of all quality elements
- ISPE GAMP5 execution - All templates
- SGP Quality Engine – execution platform
WHY CHOOSE US
- Senior Specialist - a builder
Build and use pharmaceutical manufacturing equipment is my domain. Quality- knowledge and LEAN/Six sigma are learned and used at Novo Nordisk A/S.
As manager have i develop quality activity's as equipment manufacture and align with global pharmaceutical companies.
- Customized projects - fixed execution. Good business
Quality are build in all you do!
I deliver a framework that your employee can use and bring value at development of equipment.
Fit to your your engineering knowledge and your tools.
Fit to customers exportations.
Products
Models
- ISPE GAMP5 Quality Risk Management: V-model overview with documents and important clarifications.
- Stage Gate model to reduce project risk by manage Quality, Time and Cost.
Customer alignment SQP
- Supplier Quality Plan SQP
- Align risk management related to quality and align with ISPE GAMP5
- Align with execution model - shared reference.
- Fit to general QMS and tools.
- Stake holder management.
ISPE GAMP5 templates
- URS Evaluation
- Requirement Traceability Management
- pFMEA - intended use
- FS / HDS / SDS - cross functional design specification
- Equipment Module design - fail safe implementation of controls.
- Sup-supplier management
- IO- and AWI lists
- Running in
- Protocol and test plans to FAT/SAT - test of specifications.
- FAT/SAT reports and deviation.
- Training and machine log.
WHAT PEOPLE SAY
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Ramus helped Varo improve project execution using the GAMP5 approach. He has deep GAMP5 knowledge and applies it through practical methods and templates. Ramus guided us in creating user-friendly templates throughout the project. He understands how to build intended use and fail-safe design into processes, enhancing quality and collaboration internally and with customers. With broad experience and attention to detail, I recommend Ramus for organisations seeking effective change management and GAMP5 implementation.
- Head of Project management and Seniorpartner at Varo Specialmaskiner A/S