Pharmazie + Medizintechnik – Minitab Validation with ADDITIVE

Minitab Validation with ADDITIVE

The topic of software validation becomes increasingly important for many companies. In this regard, for example, the FDA (Food and Drug Administration) with 21 CFR Part 11 has strict requirements. Each software used within a manufacturing process in the pharmaceutical industry (devices, drugs, and agents) or as part of a quality assurance system must be validated according to 21 CFR for the intended application. Also, computer systems that are used for creating, changing, and managing eletronic records and for managing eletronic signatures are subject to certain validation requirements (see 21 CFR Part 11).

The statistical software Minitab is a standard software and, in contrast to individual software, supports an efficient validation process. For the validation of this statistical software, it is helpful that all operations are logged in the background. Furthermore, methods, formulas, bibliography, as well as confirmed computation results are available. ADDITIVE supports customers during the entire validation process, including matters concerning the software as well as customized service packages.

Thanks to the log feature in Minitab, the  re-validation process can be performed quickly and cost-efficiently. Each functional modification is logged by Minitab automatically. Thus, the required test for a re-validation can be specifically restricted by means of this log, and a complete system validation can be avoided.

Moreover, ADDITIVE provides a long-standing validation expertise, being applied in a wide range of validation projects for our customers. The ADDITIVE employees give support in correspondence to the demand – from the construction of a masterplan via the installation and operational qualification (IQ or OQ) to the process qualification (PQ).

Contact to ADDITIVE Support Team by phone 0 61 72 - 59 05 - 20 or by email to This email address is being protected from spambots. You need JavaScript enabled to view it.

Minitab Validation Kit

Validation with ADDITIVE

This might be interesting as well:

© ADDITIVE GmbH. All rights, errors and amendments reserved.

Impressum  /  Datenschutz  /  AGB