Supplier Good Practices

Drive good ideas in to business

- scope and implement your business model

Practical implementation


Project Management

– Strategy Implementation.

 

Process implementation

– Project portfolio management

 

Innovative facilitation

– Set the scope for business improvement


ISPE GAMP5

- Supplier good practices to Pharma equipment supplier 

Project Management – Strategy Implementation.

  • Project Scope management - Analyse, Define, Specify.
  • Stake Holder management - Management, specialists, users.
  • Implementation - Communication, Involvement, SOP, Follow up and Continues Improvement.

 

Process implementation – Project portfolio management

  • Project execution map – Dream scenario for project execution.
  • Common Risk map – Define known risk and mitigation in your business.
  • Define common indicators – data, collection, indicators and communication.  

 

Innovative facilitation – Set the scope for business improvement

  • Problem solving – systematic and logical approach from LEAN and 6sigma toolbox
  • Idea generation – specific creative methods  
  • Process implementation – standardize “common sense” and make it repeatable.


ISPE GAMP5 - Supplier good practices to Pharma equipment supplier 

  • Failure Mode Effect Analyse (pFMEA) – Define intended use of equipment and identify critical barriers.  
  • Equipment Design Management – Function-, Hardware, and Software Design (FDS, HDS, SDS). Reference to pFMEA and customer requirements.  
  • Equipment Testing – Define test protocol and test plans. Scope FAT, SAT, IQ, and OQ.    

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