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

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

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

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

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

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

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

“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

“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

“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

“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

"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

"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

"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