The CIMS Group offers several consulting packages for your clinical organization to achieve Regulatory Readiness.
- Regulatory Assessment
- Regulatory Alignment
- Regulatory Creation
- Regulatory Branding
Achieving Regulatory Readiness requires implementation of Clinical Process Control, the CIMS Group Production of Care methodology.
Regulatory readiness depends on the implementation of an effective Regulatory Affairs initiative.
There are 3 primary constructs in the Regulatory component of our methodology:
- Policy Requirements
- Procedural Demand
- Document Expectation
There are 6 steps in our methodology:
- Regulatory Scope
CIMS Group Consultants will work with your staff to identify the Federal, National, Regional, State, and Local laws and statutes, rules and regulations that define your Organization's Required Demand Expectation.
CIMS Group Consultants will load ChartEvolve with all your relevant regulations. This exercise involves the deconstruction of regulation. Each regulatory source is broken down into its component policy knowledge statements.
- Policy Creation
CIMS Group Consultants will assign each policy statement to its own unique record. This is to assure the ability to track the Policy Requirement.
- Procedure Creation
For those policy statements for which there is a procedural demand, CIMS Group Consultants will interview your staff to determine if there is an existing procedure that covers the Policy requirement. CIMS Group Consultants will evaluate the existing Procedure to determine if it is in scope of the Policy Statement, if there is a Source Identifier
- Document Identification
CIMS Group Consultants will evaluate if you currently have documents that satisfy the provisions of the Procedural Demand and Policy Requirement.
CIMS Group Consultants will format each policy and procedure in the brand of your organization. This branding exercise is an important component of our method.