Save time, empower your teams and effectively upgrade your processes with access to this practical Regulatory Information Management Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Regulatory Information Management related project.
Download the Toolkit and in Three Steps you will be guided from idea to implementation results.
The Toolkit contains the following practical and powerful enablers with new and updated Regulatory Information Management specific requirements:
STEP 1: Get your bearings
Start with...
- The latest quick edition of the Regulatory Information Management Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.
Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…
- Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation
Then find your goals...
STEP 2: Set concrete goals, tasks, dates and numbers you can track
Featuring 992 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Regulatory Information Management improvements can be made.
Examples; 10 of the 992 standard requirements:
- Does the products required labeling provide the necessary information to use the product safely and effectively under the conditions suggested in the communication?
- Does nrc ensure that records management functionalities are incorporated into the design, development, and implementation of its electronic information systems?
- How would the reporting requirements for user facilities change with respect to electronic format, and how would annual report requirements be affected?
- Is information concerning regulatory and reputational risks and issues promptly brought to the attention of senior management and compliance personnel?
- Does nrc have written guidance for handling classified records and information and for ensuring segregation from unclassified records and information?
- How can regulatory affairs professionals add value and efficiency into regulatory compliance practices in medical device development projects?
- Does nrc have procedures in place to ensure that permanent records are identified and filed separately from temporary records?
- Has nrc integrated the management of electronic records with other records and information resources management programs?
- Do you provide information for management and regulatory reporting, and for planning and forecasting in a timely manner?
- What separate regulatory actions and decisions are being based on the collection of outside sources of information?
Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:
- The workbook is the latest in-depth complete edition of the Regulatory Information Management book in PDF containing 992 requirements, which criteria correspond to the criteria in...
Your Regulatory Information Management self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:
- The Self-Assessment Excel Dashboard; with the Regulatory Information Management Self-Assessment and Scorecard you will develop a clear picture of which Regulatory Information Management areas need attention, which requirements you should focus on and who will be responsible for them:
- Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
- Gives you a professional Dashboard to guide and perform a thorough Regulatory Information Management Self-Assessment
- Is secure: Ensures offline data protection of your Self-Assessment results
- Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:
STEP 3: Implement, Track, follow up and revise strategy
The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Regulatory Information Management projects with the 62 implementation resources:
- 62 step-by-step Regulatory Information Management Project Management Form Templates covering over 1500 Regulatory Information Management project requirements and success criteria:
Examples; 10 of the check box criteria:
- Team Performance Assessment: Individual task proficiency and team process behavior: what is important for team functioning?
- Closing Process Group: How well did the chosen processes produce the expected results?
- Activity Duration Estimates: Consider the examples of poor quality in information technology Regulatory Information Management projects presented in the What Went Wrong?
- Procurement Audit: Are bank accounts reconciled by an individual independent of the disbursement responsibilities?
- Monitoring and Controlling Process Group: Does the solution fit in with organizations technical architectural requirements?
- Project Schedule: Have all Regulatory Information Management project delays been adequately accounted for, communicated to all stakeholders and adjustments made in overall Regulatory Information Management project schedule?
- Probability and Impact Matrix: Are compilers and code generators available and suitable for the product to be built?
- Schedule Management Plan: Is current scope of the Regulatory Information Management project substantially different than that originally defined?
- Executing Process Group: Will a new application be developed using existing hardware, software, and networks?
- Schedule Management Plan: Are the Regulatory Information Management project team members located locally to the users/stakeholders?
Step-by-step and complete Regulatory Information Management Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 Regulatory Information Management project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 Regulatory Information Management project Management Plan
- 2.2 Scope Management Plan
- 2.3 Requirements Management Plan
- 2.4 Requirements Documentation
- 2.5 Requirements Traceability Matrix
- 2.6 Regulatory Information Management project Scope Statement
- 2.7 Assumption and Constraint Log
- 2.8 Work Breakdown Structure
- 2.9 WBS Dictionary
- 2.10 Schedule Management Plan
- 2.11 Activity List
- 2.12 Activity Attributes
- 2.13 Milestone List
- 2.14 Network Diagram
- 2.15 Activity Resource Requirements
- 2.16 Resource Breakdown Structure
- 2.17 Activity Duration Estimates
- 2.18 Duration Estimating Worksheet
- 2.19 Regulatory Information Management project Schedule
- 2.20 Cost Management Plan
- 2.21 Activity Cost Estimates
- 2.22 Cost Estimating Worksheet
- 2.23 Cost Baseline
- 2.24 Quality Management Plan
- 2.25 Quality Metrics
- 2.26 Process Improvement Plan
- 2.27 Responsibility Assignment Matrix
- 2.28 Roles and Responsibilities
- 2.29 Human Resource Management Plan
- 2.30 Communications Management Plan
- 2.31 Risk Management Plan
- 2.32 Risk Register
- 2.33 Probability and Impact Assessment
- 2.34 Probability and Impact Matrix
- 2.35 Risk Data Sheet
- 2.36 Procurement Management Plan
- 2.37 Source Selection Criteria
- 2.38 Stakeholder Management Plan
- 2.39 Change Management Plan
3.0 Executing Process Group:
- 3.1 Team Member Status Report
- 3.2 Change Request
- 3.3 Change Log
- 3.4 Decision Log
- 3.5 Quality Audit
- 3.6 Team Directory
- 3.7 Team Operating Agreement
- 3.8 Team Performance Assessment
- 3.9 Team Member Performance Assessment
- 3.10 Issue Log
4.0 Monitoring and Controlling Process Group:
- 4.1 Regulatory Information Management project Performance Report
- 4.2 Variance Analysis
- 4.3 Earned Value Status
- 4.4 Risk Audit
- 4.5 Contractor Status Report
- 4.6 Formal Acceptance
5.0 Closing Process Group:
- 5.1 Procurement Audit
- 5.2 Contract Close-Out
- 5.3 Regulatory Information Management project or Phase Close-Out
- 5.4 Lessons Learned
Results
With this Three Step process you will have all the tools you need for any Regulatory Information Management project with this in-depth Regulatory Information Management Toolkit.
In using the Toolkit you will be better able to:
- Diagnose Regulatory Information Management projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
- Implement evidence-based best practice strategies aligned with overall goals
- Integrate recent advances in Regulatory Information Management and put process design strategies into practice according to best practice guidelines
Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.
Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'
This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Regulatory Information Management investments work better.
This Regulatory Information Management All-Inclusive Toolkit enables You to be that person.
Includes lifetime updates
Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
