610-458-0539 Quality Systems Integrators 
In order to comply with regulations TMS quality compliance software can greatly reduce the time and effort involved in preparing for, and conducting audits. Managing and expediting tasks and quality activities ensures that your organization is AUDIT READY when customers and regulatory agencies visit your site.
QSI provides a foundation for your quality initiatives by managing documents, training records, certification, CAPA, Deviations, Audits, Change Control and more which. This is crucial for providing the auditor with the information required to thoroughly and accurately perform their job.
“Just wanted to send a quick note to let you know we had an inspector in and they were very impressed with our document and training management systems. The audit went well, and we had no trouble locating the necessary documents or training. Using TMS web has given us a level of control and organization that just wasn’t achievable manually. You came through with a big solution, for a small price.” Tina-Director of QA and Compliance
“The auditor was so impressed that he even requested additional information about your system. We indicated to the auditor that we validated and completed the system implementation utilizing 1 part time headcount within 2l/2 months from date of purchase with no additional consultants necessary. Your system is truly a big solution for a small price. I am confident that your system supports the regulatory requirements for document and training management. Thanks again for all of your support,” Gerri-Regulatory Manager
Operating an organization’s IT framework is a stringent, full-time job, which is why TMS quality and compliance software’s structure is an added bonus to help alleviate extra work for the IT department. When developing our TMS quality management systems we were aware that, in the past, many other systems on the market demanded intensive IT management and maintenance. With our unique customers in mind we built TMS on a common platform that depends less on IT involvement while maintaining and managing your company’s critical information throughout the duration of our products lifespan. TMS software solutions empower IT professionals and departments to:
“Our IT department has been very impressed with how smoothly the transition has been to new revisions of the product.”
Karen-Technology Services
With QSI, you get a systematic approach to organizing all your documents and quality records in one convenient, easy to use system which doesn’t require major IT resources to manage.
“After a complete Customer review of our Quality Management System, here are some bullet point comments’.
* 0utstanding systems”
* TMS system you have is better than anything l’ve seen
* CAPA system is excellent”
* Plans for the future are right in line with our expectations
When asked if the auditor had any concerns, the response was “ No Concerns”
Steve -Director of Quality Assurance
QSI understands that the procurement of IT resources can be a challenge which is why we offer an abundance of products and pricing options for organizations of any size, from small start-ups to companies with thousands of employees , newer companies to well established companies. QSI’s long standing commitment to understanding their multi-industry customers and their unique compliance regulations has resulted in the development of an exclusive feature rich, affordable, quality compliance software program.
Another unique cost-effective benefit is QSI licenses the entire organization. You do not have to buy different license to approve a document, edit a document, training on a document, take a quiz, or fill out a form. The reason for this is often time, you issue training to the entire organization. Users can become discouraged when they want to perform their tasks but can’t because there are not enough concurrent licenses available.
Our integrated solution allows you to characterize, record and oversee all of the individual quality processes that are imperative to regulated companies in one cohesive framework—instead of maneuvering through multiple solutions from multiple sources. This will reduce your cost of compliance and increases your chance of meeting your goals faster.
QSI is committed to providing our customers with the highest quality support for your investment. Throughout the process our Quality experts will support you during the consultation, implementation, installation and training of TMS. With ever changing regulations, it is imperative that once you are actively utilizing your compliance software you are provided with superior knowable customer support. From continuous one on one phone support, educational online demos, online training videos, and numerous other value adds services.
Improve Compliance and Reduce Risk, with QSI’s International Regulative Consulting Services
When met with the regulatory guidelines enforced by the FDA, ISO and other regulatory authorities for life sciences, companies are faced with many challenges. While TMS quality management software can put your organization on track to regulatory achievement, even the most exceptional technology will be jeopardized by inadequate quality processes. QSI Quality and Compliance Consulting (QCC) offers an array of regulatory assessment, consulting and training services that help medical device companies, drug makers, and other regulated manufacturers address their most critical quality management issues and upgrade their companywide compliance operations.
Validation Services
For organizations without validation resources, executing test scripts can be a long, tedious, time consuming project. QSI provides Software Validation Services to assure your system correctly meets the specifications of your organization and the regulatory requirements of your industry.
The team at QSI provides the expertise and test scripts (IQs, OQs, PQs) to perform validation quickly and accurately. Our validation binder includes a traceability matrix that provides mapping user requirements to the most popular features of a QMS system. For companies that are FDA regulated, we provide documentation that verifies compliance against the 21 CFR Part 11 regulation.
QSI’s IQ/OQ/PQ Validation Binder also includes:
Validation Plan & Procedures Review
Validation Execution and Screen Shots
Exception Reports and Logs
Vendor Analysis Report
”I developed, tested, and validated a workflow in TMS,
saving us a lot of time and we have had zero incidents’
I am very happy with it and so are the users
Thanks! It is up and running now (about 100 submissions so far)” Paul – Health Solutions Manager
TMS is the only off-the-shelf Windows-based solution combining indexing, document management, and training management into one easy-to-implement affordable package. Because of this unique integration, combined with TMS’s modest cost, no-load strain on IT resources, and ability to quickly automate labor-intensive environments, you can expect a high rate of return ranging between 200% and 600%. To put it concisely:
In one year your company can get back between $2.00 to $6.00 for every dollar it spends installing TMS!
Quality projects develop a high degree of urgency once management sees projections in this range. In a very real sense, time is costing your company money – maybe a lot of money. Performing this analysis will make you more cognizant that TMSWeb is a profit-generating, low-risk investment, rather than an expense to be budgeted and deferred.
Through automation, TMS is designed to increase efficiency on a noticeably large scale by allowing it’s users to navigate through a multitude of activities with ease of execution. These features include (but not limited too) ? assigned training tasks in sequence, overdue tasks, follow-ups and escalation, online quizzing, and group sign off for companies that train large groups or have employees in multiple locations. Because let’s face it, who couldn’t utilize the benefit of having more time in order to increase job performance and be the office rockstar. (you may even be able to ask for a raise!)
“I was just talking to Dan and he related to me how the TMS system has reduced
new product turnaround from 3months to 3 weeks immediately and now it just takes 3 days to get a customer a spec. Thanks for a great product.” Johnl-System Engineer
“The Training Management System (TMS) is a wonderful tool. As a Document Control Administrator, it is vital to me and our organization to have a centralized location as a gathering tool for all our documentation. It is such an easy tool to use, ability to track who has “reviewed” a document, who has a document “checked out”, who has “redlined” a document, just to name a few. Currently having over 1800 documents to control our TMS system, there would be so much more work for me to do. Per our internal client audits we are required to administer quizzes, TMS has that function as well. I also have to prepare daily, weekly and monthly reports it’s so nice to have that data at the snap of my fingers, and not spend hours collecting information and hoping it’s right. If you are tired of ALL the separate spreadsheets to control you need to have the TMS tool as part of your daily work life. Many thanks for making my work easier to do” Barb- Document Control Specialist
Support
The mission of QSI’s support team is to ensure quick, knowledgeable, and professional issue resolution you can rely on. Your support team consists of two dedicated Account Managers for Technical & Application Support who fully understand your solution and your environment. QSI provides customer access to our support team with unlimited phone, WebEx and email support. Our staff provides assistance with training queries, technical issues and product upgrades.
At QSI, we take pride in our relationships with our customers and are committed to addressing their needs. QSI’s Service offerings help customers maximize the value of their investment by aligning our expertise with TMS technology to pave the success of your quality and compliance goals. Our professional services are available to provide you with all the necessary support and resources
Training Programs
QSI delivers a full-range of training services to help your organization achieve the full benefits of your TMS software investment. Our goal is to empower your employees for the success of your organization – Your Success is our Success! We provide on-site training programs (for groups or one-on-one) which are tailored for your needs and address the specific solution being implemented. On-going training is available via online tutorials, customer support and web conferencing to make you as self-sufficient as possible.
Software Implementation
Whether your software implementation involves a single-site environment or global rollout, the QSI team offers complete support whose goal is to get even the most complex environments up and running a quickly as possible.
Based on your needs and objectives, we can guide you through specific stages of deployment or provide complete project management to systematically approach and insure that your implementation is smooth and successful.
TMS On-Site Implementation
Quality Systems Integrators provides companies with TMS Installations either On-Site or Hosted, depending on your organizational structure and IT environment. Whether choosing an On-Site or Hosted environment, QSI provides quick and easy installation to ensure effective deployment and optimal software performance. For traditional on-site installations, we provide experienced technical staff to help system administrators install and configure TMS software for their specific environment. For companies specifically seeking a private Cloud environment, or who have limited IT support, we deliver complete and secure hosting services including hardware support, updates, technical and application support, daily backup and weekly off-site backup.
“The TMS team has quickly responded to any technical issues we’ve had and quickly made corrections through system updates. The training manual for TMS is well written and the website provides additional resources.” Pam-Operations Quality Compliance Manager
“I wanted to say “Thank You” for the amazing support that you continue to provide along with the amazing product that we are using -Thank you so much for everything” Jack- Director of Quality
For over four years, QSI leadership sat on the FDA committee that developed the very guidance documents and training used for translating FDA requirements to electronic systems. That means crucial policies, procedures, and controlled content are all built into our solution. We live and breathe compliance every day and have successfully worked with more than 1,000 quality and regulatory managers.
We work closely with regulatory bodies like the FDA to stay on top of regulatory requirements. Our solutions are designed to comply with the most rigorous regulations (such as FDA, MHRA, EMA and MHLW rules), guidelines (including EU Annex 11 and ICH) and standards (ISO, GxP, EU GMP).
In order to uphold TMS’s commitment to maintain our customers standard of compliance with FDA Regulations, any add-on features that may be requested by a customer to enhance or expedite their current TMS system is always confirmed to be compliant before implementation.
For every company that is regulated it is required that they are able to demonstrate that the computerized system in place to assure compliance is fit for it’s intended use. Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.
Basically, this means the FDA and other agencies expect a risk assessment for each computer system, otherwise full validation is required. Companies without justified risk assessments will not be able to defend their selected level of validation. The real value in a comprehensive risk-based validation approach is in doing exactly the right amount and detail of validation for each system.
By empowering your management teams, employees, and contractors to accurately and efficiently execute, deliver and enhance their current processes, assignments, and production capacities you are cultivating an environment which legitimizes job performance and competency.
“Thanks to the TMS system, I am confident that we can quickly provide our SOPs, forms, and training records and have a successful audit. Thanks for such an amazing system. We are excited to start implementing the non-conformance and corrective action
modules next!” Pam – Quality Manager
With automation comes the smoother execution of tasks and procedures. By raising production standards, TMS helps businesses become more profitable by boosting employee performance.
“TMS is an amazing product & we have seen an upward spike in productivity since we went live with the system” Jack – Quality Manager
QSI’s TMS training software automates routine tasks so training coordinators can focus on the quality of the curriculum and effectiveness of the training. Documents are added into the system inordinately faster so blocks of time are not used manually creating hardcopies and internal communication is improved.
“The degree of paper reduction is astronomical,”.” In one particular case, 40 percent of an administrative assistant’s job was reduced.” Tammy- Assistant Director of Quality Assurance
“TMS system has reduced new product turnaround from 3 months to 3 weeks immediately and now it just takes 3 days to get a customer a spec. Thanks for a great product.”
Paul – System Information Manager
QSI provides industry guidance in seven core regulatory, compliance and quality disciplines:
QSI demonstrates a deep knowledge of targeted industries which enhances our ability to offer our customers superior consulting services. QSI allocates significant time, resources and expertise to provide customers with the highest quality of service.
Our competencies extend to solutions that ensure QSI customers are able to fully utilize and capitalize on QSI solutions.
QSI Consulting offers an array of regulatory, consulting and training services that helps companies address their most critical quality management issues and upgrade their companywide compliance operations.
TMS Training Matrix displays an up-to-date view of the training status of employees who have been grouped by Job Code. The training system’s advanced analytics and reporting capability will help you track and address training gaps and deficiencies.
QSI also offers a Cloud-based QMS option for those who want to abstain from larger capital expense of the more conventional on-premises installation.
TMS software solutions enable IT professionals and departments to:
100% built by industry experts
Whether choosing an On-Site or Hosted environment, QSI provides quick and easy installation to ensure effective deployment and optimal software performance.
For traditional on-site installations, we provide experienced technical staff to help system administrators install and configure TMS software for their specific environment.
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To learn more about how QSI software simplifies IT management, contact us at 1-800-458-0539.
