Features and Advantages

  • Freely definable templates, Word or many other file formats
  • Automatic population of defined Word text boxes, e.g. with title, version, owner of an SOP when creating a draft from a template
  • Assign tasks with explanations, set deadlines
  • Assign tasks to one or more task holders, who can complete the tasks in parallel or sequentially
  • Attachment management, form management with automatic cover sheet generation for the approval process
  • Automatic PDF conversion before the approval process
  • Representation of author signature, reviewer and approver signatures using digital signature capability (advanced or qualified signatures complying with signature law, meets the requirements for digital signatures in 21 CFR Part 11)
  • Monitoring of review periods
  • Training verification management, clear display of training carried out with time, training type and test type
  • Restriction of print functions to authorised users, printing rights can be withdrawn from normal users
  • Print functions for authorised users:
  • Managed printing: Prints out numbered documents complete with validity information, management of printout recipients.
  • Watermark printing: Printout with a configurable watermark.
  • Form printing: Prints out forms without the signatures added during approval.
  • Freely definable workflows and forms, e.g. CAPA, deviations, complaints, OOS etc. Implementation examples are supplied
  • Audit trail for form fields
  • Electronic signature for complete processes, including any subprocesses, e.g. for approval of planned actions by management level
  • Freely definable roles
  • Freely definable reports, e.g. on deviations in a year, related to specific equipment, processes or facilities
  • Freely definable forms for entry of information in processes, e.g. customer-specific items, rooms, criticalities
  • Also maps simple general administration processes, e.g. holiday or travel requests

Advantages

  • Users are guaranteed to always be using the latest version. Access to outdated or invalid versions is blocked.
  • Printing of unauthorised copies by standard users is blocked. Authorised users can make managed printouts. The recipients of the printouts can be entered in the system, so that it is possible to determine at any time who is responsible for the printouts.
  • All people responsible are notified in good time when a review period is set to expire. This enables the document to be revised without pressure. The notification process (timing, interval, recipients etc.) is configurable.
  • You can check current creation or revision processes at all times and monitor deadlines.
  • Notification of changes to documents to which a regulated document refers.
  • No management of signed copies necessary thanks to integrated electronic signatures (compliant with 21 CFR Part 11, GxP, signature law), but possible to meet specific requirements using the "managed printing" capability.
  • For every SOP you can monitor at any time which users have completed the training and which users have worked through the content of an SOP in self training. The different forms of training are recorded in the system.
  • Electronic communication speeds up the processes associated with document creation.
  • Reduction in regulatory risks, e.g. the SOPs actually used must be identical to the approved versions.
  • The current valid and approved version is available at all times.
  • Significant reduction in paper documents.
  • Documents are normally accessed using the familiar Windows Explorer interface.
  • Developed with a view to 21 CFR Part 11
  • Task management in creation, review, approval, training and publication phases
  • Selection of users and user groups from the normal Windows environment
  • Configurable e-mail notification of all people involved
  • Deadline monitoring, document owners and editors notified before deadline expires
  • Document owner can intervene in the process at any time
  • Management of training verification / certificates
  • Planning training for participants in training events and those using self-study
  • Creation of training verification and certificates
  • Overview of all training participants for a particular version of an SOP
  • Managed document printing
  • Documents cannot initially be printed by users
  • Printing only possible for authorised users, specifying a recipient
  • Every printout is given a consecutive number. It is assigned to the recipient
  • Watermark printing
  • Documents can be printed by authorised users with a configurable watermark
  • Electronic signature
  • Advanced or qualified electronic signatures complying with signature law and 21 CFR Part 11 based on PDF/A
  • Verifiable by recipients outside the company
  • Signature appears on the printout with all related information (name, date, reason, signature status)
  • Digital long-term archive
  • GLP compliant long-term archive
  • Long-term archiving is an integral component of the overall concept
  • Revision-proof long-term archiving on different media, including hard disk
  • Archived documents can b found using the normal search function - no special archive interface

Managed Documents

Provides electronic management of all kinds of managed documents, e.g. SOPs, qualification documents, manufacturing i... » more

Managed Processes

Enables the user to map both GxP specific processes (CAPA, deviations, complaints etc.) and general processes... » more

Training Management

The training module of BM-Flow supports you in keeping abreast of these issues... » more


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