Ensure the integrity of your electronic data in validated computerized systems
How do you validate the accuracy of your software assets inventory?
What is involved in a complete software validation approach?
What kind of tests should be carried out to validate a software?
Are measurement and validation points explicitly identified in the software specifications?
What are the main research challenges of software validation?
...Find the answers to these, and more, questions with this Computer System Validation Toolkit:
- Determine whether your data is already cast as a factor.
- Make sure the intended use, and thus your organization of validation, does not change.
- Quantitatively increase your confidence that a computer simulation correctly represents the underlying conceptual models.
- Understand how the system handles failures and whether it does it properly.
- Validate the baseline in your development and testing environment.
- Assess how the system differs from a last validated baseline.
- Troubleshoot your code to ensure it is validated.
- Move through the software and validate that its legitimate.
HOW THIS TOOLKIT WORKS:
Save time, empower your teams and effectively upgrade your processes with access to this practical Computer System Validation Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Computer System 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 Computer System Validation specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the Computer System 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 Computer System Validation improvements can be made.
Examples; 10 of the 997 standard requirements:
- 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 any device or system settings?
- 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?
- 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?
- What would the perfect all in one software solution be required to do in order to satisfy all of the different elements of manufacturing?
- How do you quantitatively increase your confidence that a computer simulation correctly represents the underlying conceptual models?
- When a user logs in to one of your computer systems, what checks are performed other than validation of user name and password?
- Is there a procedure for electronically disabling an identification code or password if it is potentially compromised or lost?
- How do you quantitatively increase your confidence that a computer simulation is an accurate representation of the real word?
- How do you cryptographically validate the integrity and authenticity of a software update package before installation begins?
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 Computer System Validation book in PDF containing 997 requirements, which criteria correspond to the criteria in...
Your Computer System 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 Computer System Validation Self-Assessment and Scorecard you will develop a clear picture of which Computer System 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 Computer System 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 Computer System Validation projects with the 62 implementation resources:
- 62 step-by-step Computer System Validation Project Management Form Templates covering over 1500 Computer System Validation project requirements and success criteria:
Examples; 10 of the check box criteria:
- Activity Duration Estimates: Do you think many information technology professionals have experience writing RFPs and evaluating proposals for information technology Computer System Validation projects?
- Risk Audit: Have risks been considered with an insurance broker or provider and suitable insurance cover been arranged?
- Duration Estimating Worksheet: Will the Computer System Validation project collaborate with the local community and leverage resources?
- Activity Duration Estimates: Will the new application negatively affect the current IT infrastructure?
- Milestone List: Describe the concept of the technology, product or service that will be or has been developed. How will it be used?
- WBS Dictionary: Is cost and schedule performance measurement done in a consistent, systematic manner?
- Planning Process Group: Are there efficient coordination mechanisms to avoid overloading the counterparts, participating stakeholders?
- Probability and Impact Matrix: Are staff committed for the duration of the Computer System Validation project?
- Project Scope Statement: Have the configuration management functions been assigned?
- Activity List: How difficult will it be to do specific activities on this Computer System Validation project?
Step-by-step and complete Computer System Validation Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 Computer System Validation project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 Computer System 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 Computer System 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 Computer System 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 Computer System 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 Computer System Validation project or Phase Close-Out
- 5.4 Lessons Learned
With this Three Step process you will have all the tools you need for any Computer System Validation project with this in-depth Computer System Validation Toolkit.
In using the Toolkit you will be better able to:
- Diagnose Computer System 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 Computer System 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 Computer System Validation investments work better.
This Computer System 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:
'The risk of our competitors getting ahead has been mitigated because The Art of Service has provided us with a 360-degree view of threats within our organization before they even arise.'
'Before The Art of Service, I waited eagerly for consulting company reports to come out each month. These reports kept us up to speed but provided little value because they put our competitors on the same playing field. With The Art of Service, we have uncovered unique insights to drive our business forward.'
'I used the questionnaires to interview members of my team. I never knew how many insights we could produce collectively with our internal knowledge.'
'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.'
'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.'
'One of my friends hired a consultant who used the knowledge gained working with his company to advise their competitor. Talk about a competitive disadvantage! The Art of Service allowed us to keep our knowledge from walking out the door along with a huge portion of our budget in consulting fees.'
'After purchasing The Art of Service toolkit, I was able to identify areas where my company was not in compliance that could have put my job at risk. I looked like a hero when I proactively educated my team on the risks and presented a solid solution.'
'I usually work until at least 8pm on weeknights. The Art of Service questionnaire saved me so much time and worry that Thursday night I attended my sons soccer game without sacrificing my professional obligations.'
'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.'
'As a new Chief Technology Officer, I was feeling unprepared and inadequate to be successful in my role. I ordered an IT toolkit Sunday night and was prepared Monday morning to shed light on areas of improvement within my organization. I no longer felt overwhelmed and intimidated, I was excited to share what I had learned.'
'I spent months shopping for an external consultant before realizing that The Art of Service would allow my team to consult themselves! Not only did we save time not catching a consultant up to speed, we were able to keep our company information and industry secrets confidential.'
'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.'
'I customized The Art of Service toolkit to focus specifically on the concerns of my role and industry. I did not have to waste time with a generic self-help book that wasnt tailored to my exact situation.'
'Honestly, I did not know what I did not know. Before purchasing The Art of Service, I did not realize how many areas of my business needed to be refreshed and improved. I am so relieved The Art of Service was there to highlight our blind spots.'
Checklists:Computer System Validation Checklist Report on SOFTWARE.pdf
Checklists:Computer System Validation Checklist Report on VALIDATION.pdf
Checklists:Computer System Validation Checklist Report on INFORMATION.pdf
Checklists:Computer System Validation Checklist Report on ORGANIZATION.pdf
Checklists:Computer System Validation Checklist Report on PROCESS.pdf
Checklists:Computer System Validation Checklist Report on VENDOR.pdf
Checklists:Computer System Validation Checklist Report on DATA.pdf
Checklists:Computer System Validation Checklist Report on SYSTEM.pdf
Checklists:Computer System Validation Checklist Report on METHOD.pdf
STEP 1 Get your bearings:
STEP 1 Get your bearings:Computer System Validation Self-Assessment Pre-Filled EXAMPLE.xlsx
STEP 1 Get your bearings:Computer_System_Validation_Quick_Exploratory_Self-Assessment_Guide.pdf
STEP 2 Set concrete goals tasks dates and numbers you can track:
STEP 2 Set concrete goals tasks dates and numbers you can track:Computer System Validation Self-Assessment.xlsx
STEP 2 Set concrete goals tasks dates and numbers you can track:Computer_System_Validation.pdf
..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
- Professional Services
- Agency Services
- 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.
When it comes to making purchasing decisions, do you have clarity on your decision-making process before possibly purchasing this Toolkit? Are there others to consider and are they supportive of you wanting to possibly get results?
What are you looking for that this Toolkit can help you with, what do you need help with specifically. Is the cost of feeling the pain far more than the cost of removing it?
Can you fill in the blanks: “I need help with … because of …?”
You are here because we have a great reputation in the space, and you specifically want this Toolkit to help you, but why now, why is it so important to solve this right now?
The answer to this question is your REAL pain:
- Why do you think this problem exists?
- What have you tried to fix it?
- How long has this been a problem?
- Is this problem affecting your life in other ways, and how?
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.
Current and desired situation:
This toolkit will give you the exact quantifiable metrics in your situation; identifying where exactly you are in the journey to solving your problem and what that looks like.
Where do you want to be, what is your desired situation: if you were to use this Toolkit, where would you want to be 12 months from now to feel like the investment was more than worth it? Make sure you set realistic expectations.
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.
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
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?
The Art of Services Toolkits only work with people that are ready to go. You do not have to work with The Art of Service, we are not here to convince you. We are just here to see if you are a good fit.
However, if you are wanting to solve your problem, this Toolkit can make that happen.
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.
What happens upon purchase: When you add to cart and checkout you will instantly be able to access the Toolkit resources, no delays, no waiting, no talking to people; this is unique and custom to our Toolkits and business. Right away the Toolkit will Guide you through a step-by-step process to get results.
If at any point you have a question, we are here for you, we are simply one email, one phone call away to get the most out of your Toolkit.