Minitab Requirements

[Arnold Gilgen]

MultiUser desktop license installations also require the Minitab License Manager (verify you have the latest version of the License Manager), which has the following recommended system requirements:

Businesses under the purview of FDA need to comply with 21 CFR Part 11 guidelines. In this article, we summarized and simplified the assessment of Minitab statistical software's compliance with respect to the FDA requirements.

These requirements aim to ensure the reliability, security, and authenticity of electronic records and signatures in regulated industries, emphasising the need for controls, documentation, and validation throughout the electronic record lifecycle.

As per Minitab's webpage on compliance, while Minitab offers some compliance features, it's ultimately the customer's responsibility to validate processes, follow guidelines, and set up broader controls.

Minitab Statistical Software provides file level password protection, which partially helps meet FDA's 21 CFR Part 11 guidelines, however that is NOT sufficient to claim 100% compliance. External / 3rd party solutions might help improve compliance.

At Factonity, we specialise not only in statistical softwares like Minitab, but also assist regulated industries in meting their validation and compliance requirements. Contact us to explore how we can assist you with additional features / software systems for CFR Part 11 compliance.

"Minitab software has been a critical component of Lean Six Sigma (LSS) projects across the Army for years. The combined team of CHESS, Army Contracting Command - Rock Island, and Minitab did a great job in putting this agreement together. It will allow Army customers to continue meeting LSS goals which ultimately contribute to making the Army run more efficiently and effectively." Said Mr. Doug Haskin, Product Lead for CHESS.

The period of performance is one 12-month base period and four 12-month option periods. Ordering will be open to the Army, Office of the Secretary of Defense (OSD) and authorized Government contractors supporting these agencies. This contract supports the Continental United States (CONUS) and the Outside Contiguous United States (OCONUS) efforts.

Based at Fort Belvoir, VA., CHESS reports to the Program Executive Office, Enterprise Information Systems (PEO EIS). Charged by the CIO/G-6 and mandated through Army Regulation 25-1, CHESS is the Army-designated primary source for providing commercial hardware and software solutions for the Army's IT requirements. Offering simple, straightforward contract vehicles through its online Army e-commerce ordering system, the IT e-mart, CHESS directly supports the CIO/G-6 strategy by providing the benefits of continuous vendor competition for best value and consolidating requirements to maximize cost avoidance and leverage the Army's buying power. CHESS works diligently with other Army Knowledge Management partners, including the U.S. Army CIO/G-6, Information Systems Engineering Command, and Network Enterprise Technology Command to provide architecturally sound, standards-and-policy-compliant IT enterprise solutions to all Army customers around the world. For more information about CHESS, visit

Different courses will require students to have access to different statistical software packages for the entire length of the course. Check the course syllabus as soon as you can to see which application is required. Various licenses can be obtained directly from the company web sites. Also, certain software can be obtained through the Software at Penn State at the educational discounted prices. (Please note: due to Federal export laws, statistical software packages can not be shipped by Software at Penn State to students living outside of the United States at this time.)

The information below is the latest that we have regarding these applications. Be certain to always check with the company's web site as there are often changes or updates to these products.

A Note to macOS users. You could attempt to use a macOS computer and Virtual PC software to run SAS. However, SAS does not guarantee the outcome. You are, therefore, strongly discouraged from using anything but a Windows PC for this software.

From the Software @ Penn State: "One license per machine. Expires annually in June, but will run for another 90-day grace period after June 30th. Customers buying the downloadable version please be aware that this is an extremely large file (27GB), if you have a slow internet connection you will want to buy the USB flash drive. We only recommend purchasing the digital download if you do not live in the continental US and are unable to purchase the USB flash drive. There are NO REFUNDS on this product."

WebLabs - Accessing Statistical Software Remotely (NOTE: Review this page. WebLabs function differently than a locally installed application and versions may differ! Check with your instructor to see if this is permissible for your course.)

Note: Students using a psu.edu email address AND who have purchased a current license for SAS from Software @ Penn State are entitled to access free SAS eLearning modules: (More Information).

The general technical requirements for the online learning courses match or exceed the technical requirements for any of the statistical packages listed above. In other words, if you meet the minimum technical requirements to enroll in an online course, then you should also have the required specifications to download and run these programs.

Purdue negotiates the availability of several software packages for student installation on personally owned machines through University sponsorship or at a reduced cost. Eligibility for the software below depends on requirements outlined within the product's software licensing agreement between vendor and Purdue University. Active student registration with the University is required.

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In the previous blog post about test method validation, we already discussed different types of test method validations, depending on the type of data and whether the test method is destructive or not. This blog is about a variable, non-destructive test method, e.g., measuring an injection molded part. This type of test method validation (TMV) might be the best way to show what TMV is all about.

Let us first explain what we mean by a measurement range. The measurement range is the range of values for which the method has been validated in terms of accuracy and precision [1]. There are two different ways to consider the measurement range in a gage R&R. One is to consider the measurement range only for the specification range of a particular test method, and the other is to consider it for multiple specification ranges. The specification range is the design requirement that defines the allowable range within which the variable must be controlled [1]. Thus, if a test method is used for only one product requirement, the measurement range may be the specification range for that requirement. However, if multiple requirements are to be evaluated, the measurement must encompass the specification range of all product requirements.

With the number of operators (O), we can assume that the more operators we use, the better we understand possible weaknesses. At least three operators must be selected from the pool of regular operators. Each operator must then independently perform the entire test method, including any necessary preparatory steps (e.g., calibration or sample preparation) [1].

Now that we know how many operators, samples, and repetitions we need, we can execute the actual measurements. The execution of the measurements should be randomized. We recommend you organize the results in the following way:

In the top right, we see the Measurement by Part graph. This contains all measurements, and outliers would be apparent here. We can also see in the graph below that the three operators have different means and different standard deviations, with operator C having the smallest and operator B having the most significant standard deviation.

The next step is to check the ANOVA table Minitab provides. The p-values provided are calculated for each source (Part, Operator, and Part*Operator). All p-values small or equal to 0.05 are considered statistically significant; thus, one can assume that 95% of parts, operator, and part*operator are significant. NOTE: statistically significant only means that there is a detectable difference, but not that this difference has any technical meaning [1].

Next, we consider the Gage Evaluation provided by Minitab. The acceptance criteria for a gage R&R study is a Total Gage R&R %Tolerance of 30%. In Figure 3, the Total Gage R&R %Tolerance for this example is 99,92%, so the study failed. In evaluating the individual Rs, it appears that the R for reproducibility is currently the largest contributor to a poor GRR result. However, even repeatability alone would not be passing.

Are you concerned about the increased requirements due to MDR (Medical Device Regulation; 2017/745) and already behind schedule? Contact us today, and we'll take the burden off your shoulders and help you make your supply chain compliant.

Minitab utilizes a Named User model. This means that everyone using Minitab will be required to have an account setup prior to each semester. Students who are enrolled in courses which utilize Minitab will be granted free access to GRCC's Minitab licensing. This access is granted for the entirety of a semester so long as the student stays enrolled in a pre approved course. Access will be granted before the end of the first day of classes and removed after finals week has concluded.

Only students who are enrolled in the following courses are eligible for this benefit. If your course is not listed in this table, and you believe it should be, please have the Director of your department email IT to have a course added.

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