Glossary

A formal process by which qualified representatives from appropriate disciplines review proposed or actual changes to an object. The main objective is to document the changes and ensure that the object is maintained in a state of control.

The processes, authorities for, and procedures to be used for all changes that are made to the computerized system and/or the system's data. Change control is a vital subset of the Quality Assurance (QA) program within an establishment and should be clearly described in the establishment's SOPs.

changes; this may be from a quality perspective for qualified/verified systems, from an engineering perspective, from a project perspective considering the cost and potential schedule impact, or a combination of these disciplines.The review will agree whether to implement the proposed change, and, if it is implemented what supporting actions are required.

Documented process for the control of change that is traceable.

(PDA) A formal process by which qualified representatives from appropriate disciplines review proposed or actual changes to a computer system. The main objective is to document the changes and ensure that the system is maintained in a state of control.

A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes (that)which might affect validated status. The intent is to determine the need for action which would ensure that the system is maintained in a validated state.

(ICH Q10) A systematic approach to proposing, evaluating, approving, implementing and reviewing changes.

A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.

An ITL role. This person is responsible for the change control process. The change manager may be empowered to authorize minor changes without CAB approval. The change manager often chairs the CAB.

An ITL role. This person is responsible for the change control process. The change manager may be empowered to authorize minor changes without CAB approval. The change manager often chairs the CAB.

The frequency at which changes are made to a product being processed in a room or piece of equipment.

The program by which a processing area is cleared of supplies and components used in the manufacture of a previous product and then readied for production of a new product. This often includes parts change over and/or special cleaning to eliminate cross-contamination.

A software tool which documents all changes made to a program.

Room where people entering or leaving a cleanroom put on or take off cleanroom clothing.

Cleavage, cracking, and furrowing of a resin bed due to resin age, a change in one of the feed solutions, or faulty operational procedures. The solution being treated follows the path of least resistance, runs through these furrows, and fails to contact active resin material in other parts of the bed.

Disrupting the structure of water, macromolecules, or living systems to promote activities that would have been inhibited by the water, molecules, or systems.

An ion that solubilizes proteins, dissolves cell membranes, and denatures DNA.

All of the characteristics of a drug substance which affect its efficacy and its purity. Or the chemical, physical, and sometimes biological properties which are attributes of a specific drug substance.

Term used to describe a short, intensive creative meeting, in which members of a team quickly collaborate and sketch designs to explore and share a broad diversity of design.

Chemical Hazards Assessment Team (CFSAN)

Computer Hazards and Operability Analysis

Chronic Hepatitis C

Chemical Contaminants Branch (CFSAN)

(IEEE) A sum obtained by adding the digits in a numeral, or group of numerals (a file), usually without regard to meaning, position, or significance.

A record of the number of bits transmitted and included with the transmission so that the receiving program can check to see whether the same number of bits arrived. If the counts match, it is assumed that the complete transmission was received.