What our clients are saying:

"The presentation of the redesigned records helped to provide a better organization of the information captured. In bringing consistency to how we record data we have reduced the number of manual entries which will lessen the time spent on record reviews."

Operations Supervisor
Consulting 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.

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EBR—Electronic Batch Records & Human Error Analysis

Excellence In Execution

Malcom Associates consultants developed the documentation and workflow simplification process in 1987 for migration to EBR. Since then, Malcom’s experienced consultants have performed and implemented over 375 batch record and SOP simplification, and electronic batch record (EBR) migration projects for pharmaceutical, biologics, nutritionals, medical devices, blood/human tissue, and diagnostic clients.

Malcom professionals don't sit in an office all day. We spend time where the process happens and where the documentation is executed. This is how we gain first-hand knowledge to quickly address your business needs and interact with our clients on all levels to improve their current systems.

Malcom’s proven approach and methodology reduces human error, improves documentation and work flow 'best practices,' and builds the road map for migration to electronic batch record (EBR). We assess, develop, test, and IMPLEMENT our solutions with achievable, measurable, and tangible results, on-time and on-budget.

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Excellence In Consulting

Our process and “best documentation practices” help clients to address and improve;

  • Human error analysis and human error reduction
  • Remediation plans
  • Documentation and process workflows
  • Regulatory requirements and commitments
  • Compliance and Systemic Issues
  • Human Knowledge Management
  • Preparation for electronic batch record (EBR)

Malcom’s experienced resources and program approach can provide the right human knowledge management solution and ‘best practices’ to make your documentation and processes less complex.

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