SAI Clinical Supply Gap Analysis:
Spataro & Associates, Inc. has developed a comprehensive methodology to specifically assess Clinical Supply Chain operations. This approach is useful to evaluatie Regulatory compliance and identify operational inefficiencies.
The outcome of the analysis is included in a report including:
- Comprehensive description of the organization’s “Current State”
- Process Maps defining inputs and outputs to pivotal tasks
- Specific identification of compliance and efficiency gaps in “Current State”
- Outcome of collaborative discussion with client to define the desired “Future State”
- Recommendations for achieving the “Future State”
- Recommended Implementation Plan (developed in collaboration with client)
Lead Process Improvement Projects:
SAI’s Approach to Effective Process Improvement Implementation Projects
- Client’s Senior Management project support
- Prioritization – clearly defined achievable short and longer term goals
- Cross-Functional team approach
- Implementation Plan (who, what, when)
Most often, process improvement projects involve the revision of existing SOPs or developing new procedures. SAI can provide the following support for GxP procedures:
- Identify which procedures are required (considering their business and compliance requirements.
- Review SOPs and define how they can be improved to assure alignment with other procedures, agreement with compliance requirements, and assure clarity so the procedures are ‘user friendly’ and suitable for use in training.
- Revise existing procedures with input from ‘user team’.
- Lead “user team” in defining existing or new procedures in a flow chart
- Clarify inputs and outputs with the team
- Identify responsibilities for tasks within the procedure
- Identify other procedures that it must align with.
- Draft new SOPs and facilitate user team member review.
- Revise the SOP and finalize obtaining final user agreement.
- Mentor or train your staff to perform these tasks.
