KNOWLEDGEBASE - ARTICLE #1962

Supplier audit questionnaires

Purpose of this page

Some institutions require suppliers to fill out lengthy forms sometimes called supplier audits or something similar. These could take hours to complete, and many of the questions are not relevant for the type of software we sell. To help companies with this process, we answer some common questions here.

Company

GraphPad Software, LLC
225 Franklin Street. Fl. 26
Boston, MA 02110
USA

Phone: 858-454-5577 (sales office)
Fax: 858-454-4150

GraphPad Software Inc. was founded in 1984, and has been dedicated to creating software exclusively for the international scientific community. Our intuitive programs provide researchers and students worldwide with the tools they need to simplify data analysis, statistics and graphing, and to learn the principles of data analysis.

We are a privately held company, so do not make public any details about our finances or the number of employees. We have hundreds of thousands of customers, all around the world.

Orders

Submit your request at help.graphpad.com with any questions about ordering, or to track an existing order. Orders are delivered electronically, via email (ESD). We typically complete an order within one business day of receipt of a valid order. 

Validation, compliance with 21-CFR-11 and the FDA 

GraphPad Prism organizes data, makes graphs and performs statistical analyses. Those analyses may be used in regulated research, but mostly they are not.  The FDA considers GraphPad Prism to be "off the shelf software". For that reason, GraphPad Software is not directly responsible for compliance with FDA regulations and we do not "validate" our software and are not ISO9000 certified. Instead, responsibility for compliance lies with the user. More from GraphPad and from the FDA

Quality control

We have approximately one tester for every two programmers and work hard to produce quality software. We are proud of our programming methodology, but do not provide details about our test plans, how we manage our source code, our methods of tracking bugs, or our programming methodology.

Note this statement from the FDA:

Software testing has limitations that must be recognized and considered when planning the testing of a particular software product. Except for the simplest of programs, software cannot be exhaustively tested. Generally it is not feasible to test a software product with all possible inputs, nor is it possible to test all possible data processing paths that can occur during program execution. There is no one type of testing or testing methodology that can ensure a particular software product has been thoroughly tested. Testing of all program functionality does not mean all of the program has been tested. Testing of all of a program's code does not mean all necessary functionality is present in the program. Testing of all program functionality and all program code does not mean the program is 100% correct! Software testing that finds no errors should not be interpreted to mean that errors do not exist in the software product.

Software configuration

We produce "off the shelf" (formerly called "shrink-wrapped") software. We do not create customized software. Our software is standalone. There are no dependencies with other software (except operating system). Prism does not interact with your company database or network (except for web access). 

Updates and upgrades

We issue new versions (upgrades) usually every few years, and bug-fix updates at least once a year. If you purchased a subscription, both upgrades and updates are included. If you bought perpetual licenses, updates are free but upgrades are available for a fee. We provide detailed release notes explaining what is new with each update. For example, here is the release note for Prism 8.0.2

You can always see the current versions of our software on our support page. From within Prism, drop the Help menu and choose Check for Updates.

Support

Submit your request at help.graphpad.com for support (or to register a complaint). We respond quickly, almost always within the same business day. We do not provide phone tech support. Why not?



Keywords: Checklist, audit, supplier, IT, survey, validation

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