Save time, empower your teams and effectively upgrade your processes with access to this practical Title 21 CFR Part 11 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Title 21 CFR Part 11 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 Title 21 CFR Part 11 specific requirements:
STEP 1: Get your bearings
Start with...
- The latest quick edition of the Title 21 CFR Part 11 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 990 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Title 21 CFR Part 11 improvements can be made.
Examples; 10 of the 990 standard requirements:
- Will your organization accept the electronic approval through the workflow system as the signature where the user who provides the final approval is validated and an audit trail it captured?
- When an individual executes a series of signings during a single, continuous period of controlled system access, is the first signing executed using all the electronic signature components?
- Are controls in place to maintain the uniqueness of each combined identification code and password, that no individual can have the same combination of identification code and password?
- Are there utilities/tools available to ensure that an electronic records audit trail captured using one version of software will be readable in the next version of the software?
- Does the information the host employer must provide to the contract employer vary depending on whether the work is done in normal circumstances or during an emergency?
- Is there a written policy in place and enforced that holds individuals fully accountable and responsible for actions initiated under the electronic signatures?
- Does the computerized system generate an email or a security log file to be reviewed by the system security group when attempts at unauthorized use are made?
- Is there is a controlled, documented process for granting access to a new user, for changing privileges for an existing user and for disabling user accounts?
- Is there is a controlled, documented process for granting access to a new user, for changing privileges for an existing user and for deleting user accounts?
- Who are the CRO team members who will work on your project, what are the responsibilities and who at the CRO is ultimately responsible for your project?
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 Title 21 CFR Part 11 book in PDF containing 990 requirements, which criteria correspond to the criteria in...
Your Title 21 CFR Part 11 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 Title 21 CFR Part 11 Self-Assessment and Scorecard you will develop a clear picture of which Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 projects with the 62 implementation resources:
- 62 step-by-step Title 21 CFR Part 11 Project Management Form Templates covering over 1500 Title 21 CFR Part 11 project requirements and success criteria:
Examples; 10 of the check box criteria:
- Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?
- Team Member Performance Assessment: To what degree can team members meet frequently enough to accomplish the teams ends?
- Activity Cost Estimates: What is the last item a Title 21 CFR Part 11 project manager must do to finalize Title 21 CFR Part 11 project close-out?
- Requirements Management Plan: Will the contractors involved take full responsibility?
- Risk Management Plan: Are the participants able to keep up with the workload?
- Lessons Learned: What were the problems encountered in the Title 21 CFR Part 11 project-functional area relationship, why, and how could they be fixed?
- Schedule Management Plan: Does the time Title 21 CFR Part 11 projection include an amount for contingencies (time reserves)?
- Schedule Management Plan: Do all stakeholders know how to access this repository and where to find the Title 21 CFR Part 11 project documentation?
- Process Improvement Plan: Purpose of goal: the motive is determined by asking, why do you want to achieve this goal?
- Project Scope Statement: Are the input requirements from the team members clearly documented and communicated?
Step-by-step and complete Title 21 CFR Part 11 Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 Title 21 CFR Part 11 project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 Title 21 CFR Part 11 project Management Plan
- 2.2 Scope Management Plan
- 2.3 Requirements Management Plan
- 2.4 Requirements Documentation
- 2.5 Requirements Traceability Matrix
- 2.6 Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 project with this in-depth Title 21 CFR Part 11 Toolkit.
In using the Toolkit you will be better able to:
- Diagnose Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 investments work better.
This Title 21 CFR Part 11 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.
