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Quick Tour Slide Show and Trial Software
Platform for Paperless Management of Your Quality System
ISOXpress is a database application for operating a paperless ISO 13485 and/or 21
CFR Part 820 quality management system (QMS). With ISOXpress you will save significant
amount of time managing the system, while improving its overall efficiency and compliance.
No more manual forms and logs, updating of documents/records binders, or Excel spreadsheets.
The software will consolidate your whole ISO 13485 QMS into a single icon on your
computer desktop.
Preloaded with Free Startup Package
Every edition of ISOXpress software ships with preloaded Startup Package that includes
template manual and procedures, internal audit and gap analysis checklist, and training
booklets for employees. An invaluable resource for those who are starting up a new
ISO 13485 quality system or just want to revamp their existing system ( more
Info)
DOCUMENT MENU Module (electronic document distribution)
The Document Menu module is like a 'Front Desk' where users come to browse, view,
print, and download documents available in the ISOXpress system.
- Documents available in the menu may be different for
each user. Only those documents for which the logged-in user has viewing permissions
appear in his or her document menu.
- Only ACTIVE (approved and released)
documents are available in the document menu.
- While displaying a document, a special
header and footer with current document control information is automatically generated
and merged with the document.
DOCUMENT CONTROL Module
The Document Control module is like a 'Back Office' where administrators and managers
create, approve and release documents and control viewing and editing permissions.
- Organize documents into a document menu tree (folder
tree).
- Import documents created in any application,
such as Excel, Power Point, MS Word, Visio, CAD software, Quark Express, or Photo
Shop — any document that can be converted to PDF (there is also a wizard for Bulk
Import of existing documents).
- Create custom headers and footers with
your company logo (or other branding).
- Maintain multiple revisions of each
document (Revisions can be ACTIVE, DRAFT or ARCHIVE).
- Approve and release documents with
the authority of electronic signatures (there is also a special process for requesting
document approvals and for releasing approved documents)
- Seal approved and released documents
to protect them against any changes or tampering.
- Attach a user downloadable file to
any document (useful for templates and forms).
QUALITY SYSTEM MANAGEMENT Modules
Eight Quality System Management modules cover all QMS activities required in the ISO
13485 standard and 21 CFR 820, thus enabling you to create and operate a completely paperless system.
Common features for these modules include:
- Receive record status alerts (due, past-due, days left,
etc) and generate record status reports
- Assign record-specific tasks to yourself
and/or to others (tasks includes a two-way communication channel with messaging,
e-mailing and attachments)
- Use electronic signatures for approving
and closing out records
- Add attachments to any record in the
system, and thus create completely paperless record trails
- Export data to Excel for charting and
statistical analysis
- Generate overview and record-level
reports
There is Plenty of Help
Using the ISOXpress software does not require any special training. Users can quickly
learn how to get things done by watching the Help Tutorials. The tutorials (slide
shows) show in simple steps how to accomplish specific tasks. For example, how to
establish new users and assign permissions, how to add a new document revision,
how to plan and monitor internal audit cycles, how to customize reports, and so
forth.
In the preloaded Starter Package there is also plenty
of instructions, tips and notes to help you establish and implement a new ISO 13485
of 21 CFR 820 system. |