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2026
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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.

HOW WE HELP

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.

CUSTOMER TESTIMONIALS

  • Quality Operations, Batch Record Review

    I like the new format, it makes it easier for both the users and myself (as a reviewer), to notice where entries are required and where entries are missing, as well as easier to notice whether or not the result recorded is in compliance with the specification.

    Quality Operations, Batch Record Review

  • Operations Manager

    I feel that the redesigned BPR (batch production record) overall, is a great improvement to our current BPR. It allows us (as Managers) to spend less time on reviewing records and more time on other important tasks.

    Operations Manager

  • Manager Manufacturing Documentation & Training

    Malcom Associates took proprietary interest from day one. Their experience, depth of knowledge, and determination to get it right has resulted in documentation that is compliant, easy to understand, and most importantly, approved by our sharpest critics….the people closest to the process! Job well done.

    Manager Manufacturing Documentation & Training

  • Production Supervisor

    I like that the redesigned documents are simpler to use because redundant entries and instructions were removed. I also like that the documents are easier to follow and are aligned with the actual process flow.

    Production Supervisor

  • Production Trainer II

    The improved format of the Batch Records has not only reduced the amount of entry points, reducing the possibilities of errors, but has also provided the Operator with a document that is easier to follow.

    Production Trainer II

  • Operations Director

    I like the fact that everything is now in the setup SOP. Previously, the specifics covering equipment setup was not available, so there was a lot of trial and error and time spent trying to get the lines ready to run.

    Senior Setup Mechanic

  • Operations Director

    I didn't think we would be able to meet the schedule on the Batch Records that had been committed to, but we did it, a number of them have been approved and are in use and the response from the operators and QA has been very positive.

    Operations Director

  • VP Operations

    “Congratulations to our personnel and the Malcom team on great execution of the project. This will be key to our ability to meet our quality and manufacturing goals as we grow in the coming years."

    VP Operations

  • Manager Manufacturing Documentation & Training

    “Malcom Associates took proprietary interest from day one. Their experience, depth of knowledge, and determination to get it right has resulted in documentation that is compliant, easy to understand, and most importantly, approved by our sharpest critics….the people closest to the process! Job well done.”

    Manager Manufacturing Documentation & Training

  • Production Supervisor

    “I like that the redesigned documents are simpler to use because redundant entries and instructions were removed. I also like that the documents are easier to follow and are aligned with the actual process flow."

    Production Supervisor

  • Vice President Quality Assurance

    “On our last FDA audit, the investigator reviewed over 60 Batch Records and no errors were found. The investigator complimented us on the clarity of the records and ease of reviewing the completed documents. The audit only took 2 days versus the 5 days scheduled. I attribute this mostly due to the redesigned Batch Records that showed we took steps to improve our workflow and processes.”

    Vice President Quality Assurance

  • Operations Manager

    "I feel that the redesigned Batch Record is a great improvement over our current Batch Record that should allow us (as managers) the time needed to concentrate on more important tasks, rather than spending excessive time on record review and investigations."

    Operations Manager

  • Operations Director

    "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 cGMP enhancement initiative, increase our work capacity, and improve right first time for us."

    Operations Director

  • Quality Operations, Batch Record Review

    "I like the new format, it makes it easier for both the users and myself (as a reviewer), to notice where entries are required and where entries are missing, as well as easier to notice whether or not the result recorded is in compliance with the specification"

    Quality Operations, Batch Record Review