Batch Documentation

Have you received a 483 or “Warning Letter” due to your product testing program?

Is your batch documentation compliant with 21 CFR Part 111?

Are you adapting to changing customer and regulatory requirements?

MKI Consulting Solutions network of experts knows what works and what doesn’t when it comes to batch documentation.  Let us develop your “Master Manufacturing Records” and “Batch Record Format” so that you ensure regulatory compliance and don’t hamper business productivity.

  • Develop and implement 21 CFR Part 111 compliant testing programs
  • Provide cost analysis to optimize profit and minimize testing costs
  • Develop or optimize MMR and BR formats

To find out how MKI Consulting can help with your “Batch Documentation” needs, contact us.