Computersystemvalidation for the pharmaceutical industry
IT-compliant - 21 CFR Part 11 - EU GMP - Annex 11 - ISO:9001 - ISO:13485
CAPA/deviation management, trainings management (QMS), raw data and document management (DMS) for the pharmaceutical industry
BIOMEDION provides solutions for document and raw data archiving3 for pharmaceuticals and other industries regulated under 21 CFR Part 11.
BM-Flow is a standard product for SOP management, training management and management of other managed documents (qualification plans and reports, computer system validation documents, maintenance logs etc.). It can be used in all GxP areas, but also in ISO:9001 or ISO:13485 certified companies.
In quality assurance, BM-Flow supports typical QA processes such as change management, deviations, specification deviations, complaint management and preventive and corrective actions. It also enables other company-specific processes to be mapped easily, and all processes can be extensively adapted to meet the customer's needs.
BM-Watcher supports raw data archiving. BM-Watcher automates electronic long-term archiving of raw data from a range of laboratory systems. The user can work on the equipment as normal and BM-Watcher automatically transfers the data to the archive, and automatically extracts the meta data from the raw data.
Integration of both products with BM-Windream allows central management and long-term archiving of all data and documents, along with electronic long-term archiving as part of an "Enterprise Content Management" system. Additional modules can be used to map non-regulated processes in marketing and sales, human resources, mailbox management, management of accounting documents, e-mail archiving etc.