Description

Configure the software on your computer and set up other devices to get your network up and running

What Is the difference between computer system validation and Software Validation?

How do end users fit in the Software Validation process for medical device regulated software?

Are your imaging hardware and Software Validation tests documented?

Do you consider whether alternative Software Validation methods must be used?

Who Is responsible for Software Validation?

...Find the answers to these, and more, questions with this Software Validation Toolkit:

Create monitoring (telemetry) to manage your DevOps software lifecycle.
Create Monitoring (Telemetry) To Manage Your DevOps Software Life Cycle.
Support your software development method with essence.
Organize, staff and govern your social software and collaboration initiatives.
Keep track of all the software assets in your corporate environment.
Control what software is running on your devices.
Ensure that your software and devices are up to date.
Protect your software against tireless hacking machines.
Gauge a software vendors potential impact to your schedule.

HOW THIS TOOLKIT WORKS:

Save time, empower your teams and effectively upgrade your processes with access to this practical Software Validation Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Software Validation 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 Software Validation specific requirements:

STEP 1: Get your bearings

Start with...

The latest quick edition of the Software Validation 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 997 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Software Validation improvements can be made.

Examples; 10 of the 997 standard requirements:

How do you verify functional coverage of the entire domain and validate completeness of the software architecture as far as it provides enough and correct services that map to business goals?
Have all action items initiated as a result of reviews, audits, working group and/or technical interchange meetings been closed and are the results of the closure satisfactory?
Does your organizations development processes for information technology applications require software to incorporate appropriate input and output validation controls?
Are the validation methods, test data, results, and conclusions documented in a form that can be understood by an independent, technically competent individual?
Have critical functions been subjected to an independent verification and validation and have all identified discrepancies been satisfactorily resolved?
What inventory related information do customers need related to the devices internal software, as versions, patch status, and known vulnerabilities?
Are you running internal checks, validation and measurements on vendors to monitor for delivery of services that are timely, accurate and complete?
Are test cases which are suitable for installation testing and regression testing identified in the set of verification and validation test cases?
Are system and acceptance testing of the software planned and performed to demonstrate that the software satisfies its requirements?
What verification is done to confirm that the security of third party software used within the IoT device meets the customers needs?

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 Software Validation book in PDF containing 997 requirements, which criteria correspond to the criteria in...

Your Software Validation 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 Software Validation Self-Assessment and Scorecard you will develop a clear picture of which Software Validation 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 Software Validation 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 Software Validation projects with the 62 implementation resources:

62 step-by-step Software Validation Project Management Form Templates covering over 1500 Software Validation project requirements and success criteria:

Examples; 10 of the check box criteria:

Activity Cost Estimates: Does the activity rely on a common set of tools to carry it out?
Procurement Audit: Is a cash flow chart prepared and used in determining the timing and term of investments?
Cost Baseline: Are procedures defined by which the cost baseline may be changed?
Risk Audit: Is the number of people on the Software Validation project team adequate to do the job?
Probability and Impact Matrix: What is the level of experience available with your organization?
Initiating Process Group: During which stage of Risk planning are modeling techniques used to determine overall effects of risks on Software Validation project objectives for high probability, high impact risks?
Responsibility Assignment Matrix: Does a missing responsibility indicate that the current Software Validation project is not yet fully understood?
Project Charter: What are you striving to accomplish (measurable goal(s))?
Stakeholder Management Plan: What is the difference between product and Software Validation project scope?
Probability and Impact Matrix: Do the people have the right combinations of skills?

Step-by-step and complete Software Validation Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

1.1 Software Validation project Charter
1.2 Stakeholder Register
1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

2.1 Software Validation project Management Plan
2.2 Scope Management Plan
2.3 Requirements Management Plan
2.4 Requirements Documentation
2.5 Requirements Traceability Matrix
2.6 Software Validation 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 Software Validation 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 Software Validation 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 Software Validation 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 Software Validation project with this in-depth Software Validation Toolkit.

In using the Toolkit you will be better able to:

Diagnose Software Validation 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 Software Validation 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 Software Validation investments work better.

This Software Validation 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.

TRUSTED BY NEARLY 200.000 PROFESSIONALS:

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'After utilizing toolkits from The Art of Service, I was able to identify threats within my organization to which I was completely unaware. Using my teams knowledge as a competitive advantage, we now have superior systems that save time and energy.'

'Many of our competitors have asked us about our secret sauce. When I tell them it is the knowledge we have in-house, they never believe me. Little do they know The Art of Service toolkits are working behind the scenes.'

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'Everyday there are new regulations and processes in my industry. The Art of Service toolkit has kept me ahead by using AI technology to constantly update the toolkits and address emerging needs.'

'Instead of investing extensive resources into an external consultant, we can spend more of our budget towards pursuing our company goals and objectives, while also spending a little more on corporate holiday parties.'

Checklists:

Checklists:Software Validation Checklist Report on MODEL.pdf

Checklists:Software Validation Checklist Report on ORGANIZATION.pdf

Checklists:Software Validation Checklist Report on DATA.pdf

Checklists:Software Validation Checklist Report on SYSTEM.pdf

Checklists:Software Validation Checklist Report on SOFTWARE.pdf

Checklists:Software Validation Checklist Report on VALIDATION.pdf

STEP 1 Get your bearings:

STEP 1 Get your bearings:Software_Validation_Quick_Exploratory_Self-Assessment_Guide.pdf

STEP 1 Get your bearings:Software Validation Self-Assessment Pre-Filled EXAMPLE.xlsx

STEP 2 Set concrete goals tasks dates and numbers you can track:

STEP 2 Set concrete goals tasks dates and numbers you can track:Software_Validation.pdf

STEP 2 Set concrete goals tasks dates and numbers you can track:Software Validation Self-Assessment.xlsx

..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.

Who This Toolkit Is For

This Toolkit is specifically designed for professionals who want to get results or those who want to sell more of their products and services such as…

Coaching or Consulting
Online Courses
Masterminds
Professional Services
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Events and seminars
Software / SaaS
Done-for-you Services

Bottom line, if you are managing high-end products and services, this toolkit will help you know more, see more and sell more - as well as train your people and co-workers to do so.

If you are a professional who wants to level-up, this Toolkit will help you do exactly that. And if you ever decide to launch products or services, this Toolkit will give you the skills that will not only serve you today as a professional but also in the future as an entrepreneur.

These skills will enrich every part of your life.

Are you ready to get started?

Are you clear on what you are struggling with, want to figure out what the problem is, diagnose it, and get a solution? The solution is something this Toolkit can provide, and we believe it can solve your problem, but you have to decide if you want to become a part of it or not.

Decision Making:

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The Reason:

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The answer to this question is your REAL pain:

Why do you think this problem exists?
What have you tried to fix it?
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Is this problem affecting your life in other ways, and how?

Tried:

What have you tried so far to fix this? Is there pain of frustration to solve this all on your own?

This Toolkit gives you your proven advisor, an advisor the vast majority of professionals do not use, because they do not know it exists. If you have tried Toolkits before, so have everyone else of our 200.000 clients. Once they use this Toolkit, they are shocked as to how they quickly get results.

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What is driving you to achieve that goal? How would that affect you or change your life. What would that look like.

The reason WHY you want something always comes down to either love or status - have clarity on your WHY.

Ownership:

What is stopping you from achieving this all on your own without any help? If your answer is one of these three answers, this Toolkit is right for you:

I do not know how to do it
I want to follow a proven process from someone that has already done it
I want to get there faster

Commitment:

When are you wanting to fix this? If the answer is now; how committed are you to making that happen? Will you do the work? Will you take action? Will you show leadership?

The fact is, it is never a good time, it is never a good time to start a new program, and it is never a good time to fix a major problem. And even if you think a later time is a good time, you know something will come up. Life will keep happening. If you truly want to solve this problem, would you agree you have to commit to solving it even when it is not the perfect time?

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Which would you like to do?

Our area of expertise is helping professionals to get the results they want so they can lead and get ahead. And we do that by pouring our experience, advise and knowledge in this Toolkit. Now, this may not be for you, but we let you decide if it sounds like a good fit so far.

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