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Raw Data Management

 
  • 21 CFR part 11 & eGLP compliance for your raw data
     
  • Fast, universal and seamless from data creation to long-term archiving
     
  • Solve the complex problem of electronic raw-data compliance easily and painlessly with BM-Windream

Cost of fragmented solutions

Most equipment manufacturers try to achive 21 CFR part 11 compliance with individual, local extensions to their existing software. This means that users are confronted with a different compliance concept for each instrument. Every local storage needs to be individually administered and secured. For each instrument a separate user administration needs to be implemented, administered and documented. Every transfer of local data to a long-term archive leads to gaps in the audit trail which are non-compliant according to 21 CFR part 11.
All of these factors add up to substantial costs even for maintaining minimal compliance in laboratories or production environments with multiple, diverse equipment.

 

 

Save time and money through standardization

With BM-Windream all raw data are saved directly into one coherent and 21 CFR part 11 compliant system. Single sign-on and a consistent access-administration for all users. A consistent backup and archiving solution maintains seamless 21 CFR part 11 compliance. The workload for users and administrators is significantly reduced.

 

 

Raw data management in BM-Windream means:

  • Uniform storage and archiving of all raw and binary data - including all proprietary formats.
  • Integrated management of all raw data and documents in one coherent system.
  • Direct storage and access to all data = work without cumbersome detours.
  • Long-term archiving including full automatic life cycle management.
  • 21 CFR part 11 compliance in its most straight-forward form.
  • Well-known user interface (Windows Explorer).
  • Reduced overhead for IT and administrators.

 

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