Glossary

This glossary describes in alphabetical order which abbreviations and wordings are used in the survey and what they mean in detail.

Catalog of Measures for a Standard IT Change

Defines which measures are used to assess whether an IT change has been successfully executed and implemented.

Change Control Procedure

is a process within quality management systems and information technology systems to ensure that changes to a product, process or system are introduced in a controlled, monitored, and coordinated manner.

CSV

Computer System Validation

DQ - Design Qualification

Is defined as a verification process on the design of a product/system to meet particular requirements relating to the quality of the product/system (e.g. relating to the pharmaceuticals and manufacturing practices)

DSGVO/GDPR - Datenschutzgrundverordnung/General Data Protection Regulation

A regulation set forth in EU law on data protection and privacy in the European Union (EU) and the European Economic Area (EEA) that also addresses the transfer of personal data outside the EU and EEA, with the primary goal of giving individuals control over their personal data.

Emergency Plan

Structure or plan to predict uncertainties and changes in projects or business processes to avoid unexpected performance or plan stoppers.

FDA - Food and Drug Administration

A federal agency of the Department of Health and Human Services in the United States, responsible for protecting and promoting public health through control and supervision of food, pharmaceutical drugs, vaccines and various different products.

GxP - Good Practice Guideline and Regulations

The general abbreviation for the mentioned guideline above where the "x" stands for the various fields including pharmaceutical and food industries. Describes in detail a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting that provides assurance that data and reported results are credible and accurate, and that rights, integrity, and confidentiality are protected at all times.

GxP - Good Practice Guideline and Regulations

Refers collectively to all guidelines for "good working practice", which are of particular importance in medicine, pharmacy and pharmaceutical chemistry. The "G" stands for "Good(e)" and the "P" for "Practice", the "x" in the middle is replaced by the respective abbreviation for the specific area of application, e.g.

· Good Manufacturing Practice (GMP)

· Good Clinical Practice (GCP)

· Good Laboratory Practice (GLP)

· Good Automated Manufacturing Practice (GAMP)

· Good Pharmacovigilance Practice (GVP)

HLRA

High Level Risk Assessment

ICH

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH); The ICH pursues the goal of standardizing the criteria for admission of a drug in e.g.Europe, the United States, Japan.

IT Change Request

Is a document containing a call for an adjustment of a system, declarating what needs to be accomplished but leaves out how the change should be carried out.

IQ- Installation Qualification

Installation Qualification (IQ) verifies that the device or system to be qualified (as well as its subsystems and any ancillary systems) has been installed and configured according to the vendor's specifications or the installation checklist.

MAA

Marketing Authorization Application - Application for admission / submission

OQ- Operational Qualification

Determines that equipment and software performance is consistent with the user requirement specification within the vendor-specified operating ranges.

PQ -Performance Qualification

Establishing confidence through appropriate testing that the finished product or process procuded by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible under real conditions.

Production Pool

Systems only used for production purposes with contact to critical infrasturcture or business processes.

RA – Risk Analysis

The Process of identifying and analyzing any potential issues that could negatively impact key business initiatives or projects.

Requirement Specification

A collection of the set of all requirements that are to be imposed on the design and verfication of a product or project.

SOP - Standard Operating Procedure

SME

Subject matter expert

Test Pool

Systems only used for testing purposes without any contact to critical infrastructure or impact on business processes.

Title 21 CFR Part 11

Part of a FDA regulation on electronic records and electronic signatures, in detail it defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.

TM or TMX – Traceability Matrix

Traceability Matrix - the key document for qualification. The traceability matrix clearly documents which user requirements (URS) are tested against which function of the system (TS-FS/DS/CS) in which qualification test or tests (DQ, IQ, OQ, PQ).

TS (FS/DS/CS)

Technical Specification (TS)

Functional Specification: Clearly and fully specifies the programme function.

Design Specification: detailed specifications of the system, for instance, the hardware/software to be used, test point lists and other particulars.

Configuration Specification: Provides a detailed technical extension of the FS and specifies how the system fulfils its parameters.

TÜV - Technischer Überwachungsverein

The Technical Inspection Association in Germany that tests, inspects and certifies technical systems and are also internationally active.

URS

User Requirement Specification

Validation Pool

Systems only used for validation purposes depicting the production structure but without contact to the real infrastructure or business processes.

VMP

Validation Master Plan

VR – Validation report

is a document that summarizes all validation results and procedures done in order to ensure that certain products and services consistently maintain satisfactory quality.

Quality Check