Competences
SOP and training management
Are you on the point of losing the overview over your document stock? Where are the managed copies of your documents? Do you really collect all the old versions of a document when a new version is published? Are the review deadlines known and are they adhered to?
With the BM-Flow-Module- “Regulated Documents” you can reliably complete all important tasks which arise in the context of managing your SOPs and policies. All relevant information concerning validity, training, approval process, review date, etc. is at your fingertips.
The concept envisages that the documents are kept exclusively electronic. As this is not always possible, we also offer advanced features for the management of controlled paper copies. Fundamentally, all documents managed by the system are not printable; however, it is possible to provide authorised users with special print functions. These include for example the “controlled print”. With this process, numbered documents with additional information attached are created and allocated to specific print recipients. With the “watermark print” the created documents are furnished with a configurable watermark.
CAPA/DCP/OOS/CCP
The management of regulated processes is a major challenge, especially when ongoing tasks and investigations are protracted over a longer period. The new BM-Flow process module helps you to track your controlled processes.
With the integrated Workflow-Designer you can modify the included example processes for CAPA, DCP, OOS and CCP. Define your own processes, necessary forms and roles. Integrate information from other systems (e.g. charge numbers) and evaluate it using equipment, rooms or user.
All entries in the formulae are subject to an audit trail. The individual forms can be equipped with an electronic signature.
Electronic long-term archiving
BIOMEDION has been dealing with the challenges of electronic archiving for many years.
The BM-windream's integrated archiving system provides an interface to current long-term archiving systems (EMC Centera, IBM DR and many more). For smaller projects, archiving on hard disc is both possible and inexpensive whilst still staying 21 CFR part 11 and GDPdU-compliant.
The technical aspects of archiving are only viable in conjunction with a comprehensive cross-archiving concept. BioMedion has realised projects for various companies, providing viable solutions despite complex issues.
Electronic Lab Journal
Is it becoming increasingly difficult to locate specific experiments in the laboratory records? You cannot afford that laboratory books get misplaced or become illegible?
Benefit from the BM-Flow module “Lab journal”.
BM-Flow automatically takes care of both the controlled filing of your records and the consecutive numbering of the lab journal entries. The drafts, created in Word, are filed as PDF with electronic signatures from experimenter and attestor
Achieve the highest operational security standards for your records with our integrated electronic archiving
Electronic signature
The electronic signature is becoming increasingly important in the pharmaceutical industry. BioMedion has had years of experience in implementing projects in which the electronic signature plays an important role.
Through this, we have been able to already solve all the basic problems, generally with available “standard” software:
