Expertise

What our clients are saying:

"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
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.

Our Expertise:


  • Increase 'right first time' quality, reduce human errors, prevent rejects, scrap, re-processing

  • Improve process understanding and work flow

  • Provide guidance on regulatory and industry 'best practice' documentation and work flow requirements

  • Improve and clarify work instructions

  • Batch Record and SOP development/creation

  • Significant decrease in line/room clearance cycle times

  • Eliminate redundant/unnecessary work practices

  • Simplify SOP documentation to make it easy to read, use, understand and follow

  • Address remediation commitments

  • EBR definition and migration roadmap

  • Training and guidance for authoring SOPs

  • Reduce errors and improve Supplier Quality Management system

  • Set-up/improve quality system to comply with GMP/regulations

  • Ready documentation system for a PAI

  • Increase capacity/throughput without additional investment

  • Reduce in-process and raw materials inventory

  • Improve sample management and accountability

  • Multi-site implementations

“Over 75% of our clients tried to improve their documentation internally, but lacked a proven approach, methodology, and resources for documentation redesign and implementation”.