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Successfully guiding clients to achieve
measurable results

EBR Since 1987

Malcom Associates consultants developed the documentation and workflow simplification process in 1987 for migration to Electronic Batch Record (EBR). Since then, Malcom’s experienced consultants continue to perform and implement batch record and SOP simplification, data integrity improvement, and EBR migration projects for life science 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 addresses data integrity, reduces human error, improves documentation and workflow ‘best practices,’ and builds the road map for migration to EBR. We assess, develop, test, and IMPLEMENT our solutions with achievable, measurable, and tangible results, on-time and on-budget.


Data/GDP Integrity

Do your batch records:

  • Comply with all cGMP requirements?
  • Identify who records the data? (i.e., roles)
  • Have redundant and unnecessary data recorded?
  • Have significant steps defined?
  • Include all necessary specifications?
  • Define when 2nd signatures are required?
  • Define verified vs witness?
  • Follow the actual process?

Our clients have:

Implemented Malcom’s Guidance for Good Documentation “Best Practices to improve overall data and GDP integrity and harmonize documentation across product lines, functional areas, and across sites.

Process Integrity

Do your procedures:

  • Follow the actual tasks/workflow performed?
  • Have steps in the correct sequence?
  • Have non-value added steps/work instructions?
  • Include unnecessary document references?
  • Have excessive revisions requiring re-training?
  • Cover all necessary processes and regulatory requirements?

Our clients have:

Implemented Malcom’s Guidance for Authoring Procedures to improve process integrity and instruct the users to utilize methods and principles to write an effective procedure. Malcom also provides training workshops on how to author effective SOPs.

EBR/MES Migration

Planning to migrate your paper-based batch record into an electronic system?

It is important to assess the impact to internal processes and the organization.

Such as:

  • Equipment interfaces
  • Other system interfaces (ERP, LIMS, EDMS, etc.)
  • MES workflow vs actual production workflow
  • Sample chain of custody
  • In-process checks
  • AQLs
  • Label verification
  • Data print outs
  • Log books
  • Transaction responsibility

EBR/MES benefits will not be fully realized until you ‘simplify and lean the existing paper batch record and data workflow FIRST’.

What We Do

We assess, develop, test, and IMPLEMENT our solutions with achievable, measurable, and tangible results, on-time and on-budget.

Need more information?

Contact Malcom Associates if you have a question or need more information.

Our Partners

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