Increase productivity and efficiency with automated TrackWise™ validation.
I've worked in computer system validation and project management for over 20 years. As a programmer at heart, I've been able to automate many tasks, creating great savings of time and money for my clients.
My experience and expertise has allowed me to hone the process of validation to be smooth and repeatable for any software implementation. I have developed a step by step Project Management methodology and automated validation tools that work with TrackWise™ to make validation efficient and painless.
My methodology and automated validation tools increase the speed of implementation, minimize cost, and increase user satisfaction of your TrackWise™ system. Validation projects are typically completed in weeks. This means your fully validated system is up and running months ahead of a typical validation process.
I always treat my clients' money like my own and strive to deliver effective and efficient solutions.
Wherever you are in the implementation or validation process, my experience and expertise can help you deliver a fully validated implementation.
What my clients are saying:
Wolf Creek Nuclear Operating Corporation — Information Services Specialist,
Sparta Systems Inc. — Senior Solutions Consultant,
Allergan Inc. — Computer System Validation Consultant,
Some companies I've worked with:
My project management methodology and automated validation tools reduce validation time to weeks and nearly eliminates human error.
Do you ever feel like you spend so much time configuring and validating TrackWise™ that you and your team don't get to run actual quality tests?
I make TrackWise™ work for you so you spend more time doing the work that matters. If you're just getting started with your implementation and aren't sure where to start, or it is taking far longer than you anticipated, let me help. I'm not only an expert at TrackWise™ validation, but also at drafting Standard Operating Procedures (SOPs) and Training Instructions. I can experiences to help you navigate the waters of 21 CFR Part 11 so that you can avoid 483's and Warning Letters.
Does the thought of an audit worry you?
Suffering through an audit can be a painful process, especially if you know you have had issues with your TrackWise™ implementation project. With my project management methodology and automated validation tools, you don't have to worry. You will have perfect traceability between your requirements and your qualification. The automated tools ensure you always have the right process in place.
If you're struggling with change control, re-validation, and time constraints, I can help you achieve your goals in record time.
TrackWise™ validation has always been a very long technical process that eats up valuable resources and reduces productivity. (The opposite of why you have the computer system in the first place.) My automated validation tools make TrackWise™ work for you by automating the process and translating the technical parts into human readable English. It makes validation so efficient and painless, you can do it with minimal resources in a matter of days or weeks. This takes the stress off your team and enhances the user experience and productivity.
You don't just get me. You get my team too!
I have the honor of working with some of the best minds in the industry. Whenever I take on a project, I make sure to include them to give you the benefit of their expertise as well. No matter the project, I will work with you directly to make sure that you and your team reach your full potential and are left with the tools you need. My team supports me and ensures each project is successful.
Contact me now to discuss your current situation. We'll set up a time to have a confidential conversation about where your project stands and how I can help. If I'm not the right guy, I'll refer you to the best resource for the job.
I'm obsessed with system validation and have dedicated most of my career to making it a painless process.
You can continue to fight with your system configuration and validation or, I will be happy to help you with worry-free validation. You'll be able to sleep better knowing that you have a fully validated system in place working for you.
Sincerely,
Joe Smith
P.S. My clients come to me because they need projects done on time, on budget, and with great success.