What We Do

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

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.

How We Help

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

Our Partners

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

Assess, Develop, Test, Implement = Results

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 such as:

Documentation that:		“fits” the process Improves “right first time” Reduces human error Reduces deviations Simplifies integration to EBR/MES
“Best Practice” Guidance Document that:		Defines documentation “Best Practices” Outlines rules/requirements Improves workflow & content Improves process understanding Addresses regulatory commitments
Eliminating		Redundancy Waste Unnecessary entries/data Excessive checks Satellite forms
Reducing Cycle Times for:		Batch Record Review Lot Release Investigations Document creation/revision EBR/MES Implementation

Results