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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.

Contact Us

How Do We Get Started?

We conduct a Value Assessment to identify opportunities, potential "compliance gaps", and the justification for the recommended path forward.

Examples of what we Assess:

  • Compliance and industry “best practice” gaps and the recommended fix

  • Opportunities to reduce human errors.

  • Unnecessary and/or redundant instructions, entries, forms, and data.

  • Work instructions that are incomplete, inadequate or not clearly stated.

  • Inconsistency in how instructions, parameters and specifications are stated within the Batch Record or other documentation/ systems.

  • Operator recorded data, where no specification/ parameter is stated for comparison or is incorrect

  • Sequence of steps in the Batch Records, SOPs, or work flow do not accurately follow the process, increase cycle times or are not streamlined to meet business demands.

  • Readiness for automated/electronic environment and system integration.

We can also conduct a business ROI analysis to provide financial and process improvement justification.

Questions?

Contact Malcom Associates at Info@malcom-us.com