|
 |
| What Are the Benefits of a DMS System? Find out more... |
No matter whether commercial documents, batch documentations or marketing
authorisation documents are at issue: Regulated environments require
that documents of any kind are archived in read-only form, easy to find,
available for multi-level processing and distribution. Very strict regulations
apply to "... the documentation of all operative processes, inasmuch
as they concern the purchasing, manufacturing, testing, storing, importing
and trading of medicines..." [Pharm-BetrVO].
For these kinds of documents, the highest degree of access protection
and audit trailing must be guaranteed.
Computer-aided document management using PharAO® satifies these requirements, and offers decisive advantages over a mixed hardcopy/disk filing system. Test it and see for yourself!
GMP Compliance/CSV Templates:
- Qualified system, compliant with EU/FDA standards, including document templates for validation purposes (e.g. SOPs, validation master plans, risk analysis, DQ-, IQ-, OQ- and PQ templates).
 |
 |
 |
 |
 |
| validation model procedure |
Document Transfer
- Transfer of scanned documents: Drivers for scanner selection, for a wide variety of scanners
- batch management including the transfer of other files: Uploading of image files in any graphics format supported by PharAO® (BMP, TIFF, JPEG etc.)
- uploading of application files (PDF, DOC, XLS etc.)
- time-controlled automatic uploading of files from a transfer directory
- importing of files con-taining indexing data (CSF, CSS, XML)
- automatic transfer of in-coming e-mails or fax messages using predefined filters
- fully au-tomated print data transfer from ERP- and other IT systems.
automatic print data transfer and indexing
Document Indexing
- Barcode identification, ICR/OCR identification of text and handwriting, as well as OMR identification of markings within predefined areas
- automatic indexing by reading out certain information from the document (using OCR/barcode)
- automatic indexing by transferring data from linked systems (e.g. Scarabaeus+, SAP R/3, etc.).
Document Finding/Calling
- Document searches using indexing information and full-text search
- searches using wildcards and logical operators (AND, OR, NOT) as well as area searches
- saving of queries
- marking hits in scanned documents (including OCR interface option).
Document Protection and Audit Trailing
- Assignment of user rights (e.g. read, change, process black bars) for each document
- automatic check-out when processing documents
- protection against unauthorized access by saving file in a file format that cannot be read without the PharAO® document server
- automatic creation of a new document version after each change, using automatic audit trailing
- document encryption and electronic signature (including security option).
Document-specific access list
Teamwork/mail basket
- Filing of documents to be processed in user- or group-specific baskets
- user-specific access authorization for baskets
- forwarding of documents to filing baskets of individual users or groups using Drag & Drop
- setting of cross-references between documents or between documents and hit lists of search queries
- sending document links via e-mail.
user interface mail baskets
Workflow
- Simple definition of workflow structures, using the Process Designer
- mapping of parallel and serial processes
- free definition of workflow tasks (e.g. signing, releasing, rejecting, and forwarding of documents)
- defining of workflow-related access rights
- automatic resubmission of scheduled tasks
- defining of users, roles or groups as recipient of a given workflow task
- escalation and substitution regulations
- online information on the processing status or processing history
- interfaces with standard Microsoft and Lotus e-mail products
- automatic distribution of documents after processing.
Workflow example: changing a process instruction (SOP)
Archiving and Long Term Storage
- Archiving and storing of documents via the document server
- high performance archiving back-end for read-only filing on optical media
- control of diverse storage locations worldwide
- drivers for all standard jukeboxes
- support for RAID ARRAYS
- archiving of unlimited numbers of documents
- data compression up to 95%
- saving of documents on all standard data carriers (magneto-optical media, WORM media, etc.).
Yet Other Features of PharAO®:
- Expansion into a management system for electronic marketing authorization documents according to the eCTD standard
- integration into our pharmaceutical PPS / MES Scarabaeus+ or connecting with other ERP system
- MS office connection for archiving documents directly out of MS Word, MS Excel, MS Powerpoint, MS Outlook.
