Electronic Long-term Archive

Since legal requirements for electronic storage of information have been in force, the issue of electronic long-term archiving has increasingly been a focus of commercial interest. Directives and legal requirements include FDA 21 CFR Part 11, OECD Advisory Document No. 15, principles for data access and verification of digital documents (GDPdU), principles of proper IT-based book keeping systems (GoBS) and regulations imposed by commercial law and the tax code (HGB/AO).

However, meeting legal requirements is not the only crucial factor when it comes to effective use of electronic archives. There are other important technical arguments in favour of rigorously replacing traditional paper-based archives, including

  • Faster searching for information and immediate access to documents,
  • Less space required despite constantly increasing data volumes thanks to integrated "single instancing",
  • Convenient transfer of documents to media with large storage capacities such as DVD, WORM, PDD and UDO media,
  • Maximum data security due to the use of state of the art archiving and backup technologies,
  • All archived information available for an almost unlimited time.

It goes without saying that the long-term archive integrated into BM-Windream meets all of the requirements stated. Apart from the general advantages, however, what sets the software apart from most archiving systems available in the market is its range of additional features . The almost unlimited data volume and the seamless integration into the BM-Windream document management system are just two of many.

A variety of different technologies are supported, including both SCSI and USB, as well as IDE and IEEE1394 (firewire and iLink) for connecting optical media. Whether they want to use blue laser devices such as UDO and PDD drives, RAID systems in an HDD network, jukeboxes with optical DVD or WORM media, NAS, SAN, iSCSI, EMC Centera or onDemand from IBM - our users have total freedom when it comes to choosing the most appropriate subsystem. Documents can even be archived in different archiving systems in parallel.

arivis BM-Windream

  BM-Windream is the 21 CFR Part 11 compliant data and document management system for the pharmaceutical industry. It is based on the market leading windream document management system from wi... » more

arivis BM-Flow

BM-Flow supplements your BM-Windream system with functions for document management (e.g. for SOPs, manufacturing instructions, test plans, validation documents etc.) and management of typical quali... » more