Ever thought about what ‘readily available’ means?
FDA regulative 11.1(e) "Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection".

FDA regulative 211.180 (c) "All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph."

Maintaining the exact data
Have you ever tried having a document referring to a specific version of a Standard Operating Procedure or another document? Sure you have! Does your company have a system for storing documents? You bet - and it works just nicely!

It probably does, but when years go by and judgment day comes around, you will most likely find that your systems will present the most recent versions of your documents, but try to ask the system for a 3 versions old document. What did you get - Readily available?

The user challenge
For anybody who ever tried this, it is obvious that this is not the most wishful situation. Consider the advantage of being capable of referring to the exact information, stored in a virtual binder, readily available with a few pushes on the buttons. QAbinder™ stores the documentation referenced from other documentation.

Virtual binders organized as nicely as physical binders, but readily available via a Web -interface
QAbinder™ provides everything you ever wanted from physical binders - just electronic. QAbinder™ stores all types of electronic data in virtual binders, with binder backs, index pages and information. All binders are fully searchable, and it is possible to print physical binders from the virtual ones. Furthermore, the  access to information in the binders are subject to a full 21 CFR Part 11 compliant audit trail, so that it can be found who and when data was submitted to the system, and data are disabled rather than deleted from the system, so that no information is ever lost.

It is possible to directly link to the information inside QAbinder™ via the unique IDs of the contained data, and QAbinder™ works as data storage for other QAtor applications. The virtual binders are stored neatly on shelves in cabinets, just as you could find data stored in the physical world. QAbinder™ also implements restricted binders that allow only a limited amount of people to access specific binders and their contained data.

Binders can be stored in projects, which are groups of related binders, and QAbinder™ supplies a number of pre-defined reports for easy overview of system contents. Data inserted in binders can be "signed off" if required, and notes can be added to each document attachment. If documents are transferred from physical documents via a scanner interface, the system can furthermore contain references to the physical location of the original documents (handy for inspections, since this is a regulatory requirement).

The system comes fully validated with template documents for roll out, and template procedures for system use.

System Requirements

• CLIENT: Microsoft Internet Explorer v6.0™ or Netscape 7.0 and higher, Adobe Reader™
• SERVER: Oracle Database v8 or higher

Contact us