Documentation

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
Consulting and Electronic Batch Records 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.

Documentation We Improve

  • Batch Records

  • Device History Records

  • Medical Records

  • Process SOPs and Work Instructions

  • Cleaning and Maintenance SOPs

  • Supplier Quality SOPs

  • Laboratory Methods/Assays

  • Process Forms

  • Process Development/R&D

  • EBR/MES, system SOPs

  • And Many More.................