21 Cfr Part 11 Toolkit

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Implement, upgrade, and support Software Development while ensuring compliance with SOP, ISO 9001, ISO 27001, GDPR, HIPAA and 21 Cfr Part 11 compliance.

More Uses of the 21 Cfr Part 11 Toolkit:

  • Involve in documentation of different stages of validation life cycle in compliance with 21 Cfr Part 11.

  • Systematize: review clinical research study protocols for database update implications.

  • Supervise: proactively seek methods of improvement, streamlining workflows, and building efficiencies in individual work and project outcomes.

  • Generate data listings to facilitate central review needed for data clean up, database reconciliation, data review, and discrepancy management.

  • Oversee: 21 Cfr Part 11 related to computer systems etc.

  • Manage: report progress to appropriate Project Management, Clinical Operations, and safety.

  • Reconcile 21 Cfr Part 11 regulations and Data integrity compliance.


Save time, empower your teams and effectively upgrade your processes with access to this practical 21 Cfr Part 11 Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any 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 21 Cfr Part 11 specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the 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 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which 21 Cfr Part 11 improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Has a cost center been established?

  2. Are you paying enough attention to the partners your company depends on to succeed?

  3. Will the controls trigger any other risks?

  4. What is the best design framework for 21 Cfr Part 11 organization now that, in a post industrial-age if the top-down, command and control model is no longer relevant?

  5. How are policy decisions made and where?

  6. Has your scope been defined?

  7. How much data can be collected in the given timeframe?

  8. What improvements have been achieved?

  9. How do you gather 21 Cfr Part 11 requirements?

  10. Has implementation been effective in reaching specified objectives so far?

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 21 Cfr Part 11 book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your 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 21 Cfr Part 11 Self-Assessment and Scorecard you will develop a clear picture of which 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 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 21 Cfr Part 11 projects with the 62 implementation resources:

  • 62 step-by-step 21 Cfr Part 11 Project Management Form Templates covering over 1500 21 Cfr Part 11 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all 21 Cfr Part 11 project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the 21 Cfr Part 11 project team have enough people to execute the 21 Cfr Part 11 project plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed 21 Cfr Part 11 project plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete 21 Cfr Part 11 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

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 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 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 21 Cfr Part 11 project with this in-depth 21 Cfr Part 11 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose 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 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 21 Cfr Part 11 investments work better.

This 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.