Die Computersystemvalidierung stellt in immer mehr Branchen eine Standardaufgabe zur Einhaltung und Aufrechterhaltung der geltenden Regularien und zum Schutz der Patienten dar. Dabei ist der Prozess oft noch sehr aufwendig und bremst die Fachabteilungen und das Business unnötig aus. Der Aufwand um dies fehlerfrei, konsistent und vollständig nachvollziehbar zu realisieren ist extrem zeit-, ressourcen- und damit kostenintensiv.
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.
Defines which measures are used to assess whether an IT change has been successfully executed and implemented.
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)
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.
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.
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.
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.
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.
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.
GAMP refers to Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users in the pharmaceutical industry.
Determines that equipment and software performance is consistent with the user requirement specification within the vendor-specified operating ranges.
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.
The Process of identifying and analyzing any potential issues that could negatively impact key business initiatives or projects.
A collection of the set of all requirements that are to be imposed on the design and verfication of a product or project.
Standard Operating Procedure
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.
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).
is a document that summarizes all validation results and procedures done in order to ensure that certain products and services consistently maintain satisfactory quality.
Validation Master Plan
Systems only used for validation purposes depicting the production structure but without contact to the real infrastructure or business processes.
User Requirement Specification