Title 21 CFR Part 11 Toolkit

Downloadable Resources, Instant Access

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 998 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 998 standard requirements:

  1. Does the system generate electronic records that are available for review in both human readable and electronic form that accurately and completely reflects the source data, including audit trails?

  2. What descriptive or other metadata schema or standards are currently being used in the creation, maintenance, use and preservation of the recordkeeping system or environment being studied?

  3. Did the validation testing include accuracy, reliability, integrity, availability, and/or authenticity of the electronic record and associated electronic signatures including audit trails?

  4. 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?

  5. Does system validation include testing that the electronic signature cannot be edited, deleted, copied or transferred to a different record (including copies of the electronic record)?

  6. When filing electronic records is there guidance on what needs to be incorporated into the title description to ensure accurate retrieval by third parties within your organization?

  7. Is there a secure, computer-generated, time-stamped audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records?

  8. Is there a secure, computer generated, time stamped audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records?

  9. 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?

  10. Does the policy provide for the concept of a trusted custodian to hold or be responsible for the management of inactive records (for records in electronic and physical form)?

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 998 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:

  1. Project Schedule: Your best shot for providing estimations how complex/how much work does the activity require?

  2. Stakeholder Management Plan: Are regulatory inspections considered part of quality control?

  3. Procurement Management Plan: Is the Title 21 CFR Part 11 project schedule available for all Title 21 CFR Part 11 project team members to review?

  4. Planning Process Group: Product breakdown structure (pbs): what is the Title 21 CFR Part 11 project result or product, and how should it look like, what are its parts?

  5. Quality Audit: Has a written procedure been established to identify devices during all stages of receipt, reconditioning, distribution and installation so that mix-ups are prevented?

  6. Assumption and Constraint Log: How relevant is this attribute to this Title 21 CFR Part 11 project or audit?

  7. Activity Duration Estimates: What distinguishes one organization from another in this area?

  8. Cost Management Plan: Is there a formal set of procedures supporting Issues Management?

  9. Procurement Management Plan: Are there checklists created to determine if all quality processes are followed?

  10. Probability and Impact Matrix: Is the customer willing to establish rapid communication links with the developer?

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



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.