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.
- Integrity of the data. What is recorded, how is it used
- Sequence of steps in the Batch Records, SOPs, or workflow 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.
- FMEA and Risk Management Process
- Quality Systems gaps
We can also conduct a business ROI analysis to provide financial and process improvement justification.