EBR

What our clients are saying:

"I liked the approach and methodology, involving the SMEs from the Operations and QA areas working together to improve our Records and redesign of the information flow. The redesigned Records will support our GMP enhancement initiative, increase our work capacity, and improve right first time for us."

Operations Director
Consulting and Electronic Batch Records What We Do

Malcom has developed a proven approach, methodology, industry documentation and work flow “best practices”. We assess, develop, test, and IMPLEMENT our solutions with achievable, measurable, and tangible results, on-time and on-budget.

Consulting Solutions How We Help

Our redesign solution ensures quality issues are resolved and that the documentation, procedures, manual or automated work flow "fits" the process.

Record Keeper Our Partners

Malcom Associates partners with software and service providers to reduce implementation time, internal resources and investment.

Are you evaluating EBR/Manufacturing Execution System (EBR/MES)?



EBR/MES benefits will not be fully realized until you ‘lean the existing paper Batch Record documentation FIRST’

Our program will:

  • Lean the Batch Record documentation for easier migration to EBR/MES

  • Eliminate redundant information and identify what data to integrate to EBR/MES

  • Develop strategy for interface and implementation of electronic systems

  • Validate or invalidate user and functional requirement specifications

  • Revise and create SOPs to support and comply with system functionality and interfaces