Glossary of Terms
What is Annex 11?
Annex 11 is part of the European GMP Guidelines that defines the scope and limitations for computerised systems used by organizations in the pharmaceutical industry. Annex 11 defines the criteria under which electronic records and signatures are considered to be managed. It acts as a checklist for European regulatory agencies to establish the requirements for computerised systems for pharmaceutical products and medical devices.
What is an Annotation?
An Annotation is a note or comment that serves as extra information associated with a document or project.
What is Artwork?
Artwork is a printing matter which is placed on a product’s packaging material. It generally includes graphics, logos, barcodes, and product information. Packaging Artwork plays an essential role in communicating with the customer and contributes to the overall branding of a company.
See also: Branding
What is Aseptic Packaging?
Aseptic Packaging is a specialized packaging process in which food, pharmaceuticals, and other products are sterilized separately. The products are then inserted into the packaging container in a sterile environment. Aseptic Packaging prevents microorganisms from entering a package, producing shelf-stable products that do not need refrigeration.
See also: Medical Packaging
What is an Audit?
An Audit is a quality review process that evaluates a quality system with the intention of improving it. The purpose of an Audit is to provide management with information on