What are the uses of computer software

Is your statistics software validated by the FDA for pharmaceutical products?

We are often asked if Minitab is approved by the U.S. Food and Drug Administration (FDA) is validated for use in the pharmaceutical industry.

Minitab performs extensive in-house software testing, but our statistical software does not - and cannot be - FDA-compliant by default.

No software can do that.

It is often mistakenly believed that software manufacturers can go through certification to obtain FDA software validation. But that's not true.

Software vendors who specifythat their products are FDA validated should definitely be questioned. The software purchaser is responsible for validating the products used in production or as part of a quality system with regard to the intended use. This is explained in the FDA's Code of Federal Regulations (Title 21 Part 820.70 (i)):

“If computers or automated data processing systems are used in the context of production or a quality system, the manufacturer must validate the computer software with regard to the intended use according to a specified protocol. All changes to the software must be validated prior to approval and publication. The measures and results of the validation must be documented. "

For medical device companies, the FDA provides additional information in Section 6 under “Validation of Automated Process Equipment and Quality System Software” in “Principles of Software Validation; Final Guidance for Industry and FDA Staff "(January 11, 2002).

“The device manufacturer is responsible for ensuring that the procedures used by the OTS software developer (off the shelf, standard software) for product development are suitable and sufficient for the intended use of the OTS software by the device manufacturer. For OTS software and devices, the device manufacturer may have access to the manufacturer's documentation of the software validation, but this is not always the case. If the manufacturer can provide information on the system requirements, software requirements, validation procedures and results of the validation, the medical device manufacturer can use this information from the starting point for the required validation documentation. "

Intended Use

There are good reasons for the “planned use” requirement. Here is an example:

Company XYZ uses Minitab Statistical Software to estimate the likelihood of an error in a manufacturing process. If the amount of an impurity exceeds 450 mg / ml, the product is considered defective. For example, suppose the company is using the Capability Analysis> Normal feature in Minitab statistical software for capability analysis.

In the first graph below, you can see that the Ppk (1.26) and failure rate (82 defects per million) are generally quite good. However, based on these numbers, if the manufacturer thought it was a good process, it would be wrong.

The Minitab statistics software did not calculate anything incorrectly, but because the data is not normally distributed, the incorrect method was used. If this were the only capability analysis available in Minitab statistical software, the software could not be validated for capability analysis with nonnormal data.

Fortunately, there is one in Minitab Statistical Software Process capability analysis. If Capability Analysis> Abnormal is selected with an appropriate distribution (in this case, Weibull), the Ppk (0.69) and failure rate (8993 defects per million) are rated poor, as shown in the following graph shown

What needs to be validated?

Software packages such as Minitab that can be used to monitor a process and determine the level of quality should be validated. To validate Minitab, you must document its "intended use".

The validation with regard to the intended use consists in assigning the software requirements to test cases. Each requirement must correspond to a test case. During the test, a system can be categorized as “not validated” if a requirement is found without a test case.

You can monitor requirements and test cases with a dependency matrix.

A test case should include:

  • A description of the test case. Example: Validation of the capability analysis for non-normally distributed data.
     
  • Execution steps. Example: Open "Statistics"> "Quality tools"> "Capability analysis"> "Not normal", enter the column to be evaluated and select the appropriate distribution.
     
  • Test results (with screenshots).
     
  • Determining whether the test passed / failed.
     
  • Date and signature of the examiner.

Software validation warning letters

Many warning letters that manufacturers receive refer to a violation of these guidelines. Below is a paragraph from a warning letter referring to incorrect validation of an OTS help desk software product and document management tool

29.05.2009
Lack of validation of computer software with regard to the intended use according to a given protocol when computers or automated data processing systems are used in the context of production or a quality system, as required by 21 CFR § 820.70 (i). This is a recurring breach of a previous FDA-483 for your company. Examples:
A) Your company uses OTS (***** Help Desk) software to manage customer support calls and store configuration information on customer websites. However, the software has not been sufficiently validated to ensure that it works as intended for this use case. In particular, the validation by your company did not ensure that the details screen worked as intended. Details on complaints and information on how to deal with complaints are recorded on the detail screen. These include Corrective and preventive actions your company takes when service calls are categorized as CAPA issues.
B) OTS software (***************) is used by your company for the management of documents in the quality system for the control and approval of documents. However, this software has not been sufficiently validated to ensure that it meets your requirements and is suitable for the intended use. Specifically, there were two different versions of the CAPA and Customer Complaints Procedure (SOP-200-104) at the time of the audit, but no revision history was specified in the document history for *************** Your company has not been able to validate that the *************** meets your document management and versioning needs.

Here are two other examples of software validation violations in an FDA warning letter:

25.03.2010
"Lack of validation of computer software with regard to the intended use according to a specified protocol if computers or automated data processing systems are used in the context of production or a quality system, as required according to 21 CFR 820.70 (i)." ... "No validation documentation for Provided the commercial OTS program (b) (4) for recording complaints, returns and service requests. "

25.02.2010
"Lack of validation of computer software with regard to the intended use according to a specified protocol if computers or automated data processing systems are used in the context of production or a quality system, as required by 21 CFR §820.70 (i) (production and process control - automated processes) . "..." The CAPA analysis of the shortcomings used in management meetings is insufficient because the report is generated on a computer with an unvalidated software system. "

Minitab validation resources

It is the responsibility of the software purchaser to validate the software for its intended use. If you are using Minitab Statistical Software, we provide resources for this validation. You can download the Minitab Software Validation Kit here

This software validation kit is designed to show you how we are validating Minitab Statistical Software's market readiness and demonstrate Minitab's high standards of quality.

If you have any questions about the validation process for our software, please contact us.