The predetermined result of a specified test

Action limit, if violated act in accordance with the correction plan

Action limit, if violated act in accordance with the correction plan

Provision, i.e. cleanroom system fully connected and functional but without production facilities, without equipment and without staff.

A systematic investigation to determine whether the defined processes, instructions, specifications, rules and standards as well as other applicable contractual or licensing requirements are suitable to reach the goals and whether these are in operation.

A system that executes or monitors a specific sequence of activities, such as a production process, a laboratory task or a data processing order automatically and without human intervention.

Narrative explaining all assumptions or clarifications made in developing the estimate.

Determination of a measuring discrepancy between the test medium and the reference

A formal procedure with the help of which qualified persons from the respective disciplines check suggested or performed changes that can impact the validated status of the system. The goal is the determination which measures need to be performed and documented to retain the validated status of the system.Note: This term is used in two situations:

• during project processing (project change control)
• during operation (on going change control)

A production or laborary system, the key components of which is a control system.

Often used as a synonym for control system qualification

The area within and/or in the vicinity of a machine in which the safety or the health of a person is at risk by the person’s presence in this area.

->Hardware design specification <br/> ->Software design specification

Specification that defines the functions to be provided by a system or system component. The system is tested against this specification.It is defined, in the specifications, HOW and WITH WHAT the requirements are to be realised.

A standards based, formal and documented approach in development, which ensures that the results of technical planning do not depend on the mode of operation of individuals but on the result of a planned process for the generation of high-quality planning documentation.

Description of the hardware on which the software runs and how it is linked to other system or operating components.

Formal and systematic proof that all relevant aspects of system installation (hardware and software) correspond with the agreed rules, are in compliance with the approved execution documents and take into account the suppliers’ recommendations.

A total of associated parts or appliances of which at least one is movable and, if necessary, of operating devices, control and energy circuits etc., that have been assembled for a specific application such as the processing, treatment and transport of a material.

Autonomous laminar flow module

All conditions and activities that impact the observed system either directly or indirectly.

Production, i.e. cleanroom system running in the agreed mode of operation with the scheduled number of staff.

Formal and systematic proof that the entire automated system corresponds with the requirements in the context of the scheduled operating areas and integrated production areas.

Formal and systematic proof that the entire automated system corresponds with the requirements in the context of the scheduled operating areas and integrated production areas.

Formal und systematic proof that the premises and equipment (including production systems and control system) are suitable for the scheduled tasks. The qualification is split by:

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Micro Biological Qualification (MBQ)
• Performance Qualification (PQ) -> Client

Determination of the recovery time of a cleanroom zone. Time interval within which the particle concentration droops to 1% of the initial value.

The specifications define WHICH task is to be solved and WHY

Repetition of the entire validation or a part thereof.

Definition of the protection class with regard to personal, product protection and cross-contamination using the “KI-Discus-Verfahren”

I.e. test values are restored to the national standard

Instruction which describes how something is to be executed. SOPs regulate the operation and the service of procedures. Compliance with the SOPs thus also serves the maintenance of requirements.

Software test that the software developer or programmer performs with the knowledge of the actual program structure. The program sequence (source code) is tested; in so doing, each program path must be run through at least once and every instruction must be performed at least once. No part of the program may remain untested.

A high-level process narrative including system boundaries based on operational/functional requirements.

Target value, no measure required if it is not exceeded. There are the following levels:
A. Physical security
B. Logical security

(A plan for „hand-over“ of „transfer of responsibility“ of the project.)

The company or group within a company that is responsible for the operation of a system.

See “Application-based software”

Formal and systematic proof that a process is highly likely to generate a product that meets specifications and quality requirements permanently

A prospective execution plan, the processing of which is to provide the formal and systematic proof that the system is qualified.