Independent ERP and Lean & Operational Excellence Consultants

 

Electronic Batch Record (EBR) Strategy

Interest in paperless manufacturing through the implementation of an Electronic Batch Record (EBR) continues to grow, as pressure to reduce unit costs and release lead times increases.

The implementation of an EBR is a very large project for most pharma organisations, and consequently the project strategy and delivery cycle is lengthy. BSM recognises this and has developed service offerings to support different stages of the cycle. These are summarised below.

You & EBR   BSM Service   Objectives
Very early stages – no shared agreement on the scope of EBR, how it relates to MES, what it might mean for your company and no definite implementation plans. > One-day EBR
Workshop
> Development of a clear and shared understanding of EBR, and of the detailed steps required to decide what level of implementation is appropriate for your company.
EBR is actively being talked about in the company – either as a result of a local initiative or because it is being implemented in the corporation. Not yet budgeted for because of uncertainty as to likely costs or timescales. > EBR Assessment > Development of detailed and realistic cost and benefit models, that can feed directly into the budgeting process and corporate level presentations.Development of a high-level implementation project plan.
You have determined that EBR makes financial and operational sense for your company. However, the technology on which the EBR is to be based is not yet decided. > EBR System
Selection
> Using a highly structured and quantitative selection methodology, identify the technology solution that provides the best mix of cost and functionality, while at the same time generating objective reasons why other potential solutions have been rejected.
You have a definite plan to start implementation of an EBR project in the near future, but are struggling to resource the project. > EBR Project
Management
> Provide a project manager and/or implementation support consultants with real EBR implementation experience to supplement your internal team.