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Quick Tour Slide Show and Trial Software
10 Integrated Modules
- Document Menu
- Document Control
- Corrective/Preventive
Actions (CAPA)
- Internal Audits
- Management Reviews
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- Training
- Supplier Control
- Nonconforming Products
- Customer Complaints
- Measuring Equipment
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Platform for Paperless Management of Your Quality System
ISOXpress is a database application for operating a paperless ISO 13485 and 21 CFR
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.
DOCUMENT MENU Module
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).
- Create documents in an integrated editor,
or import external documents created in any application, such as Excel, Power Point,
MS Word, Visio, CAD software, Quark Express, or Photo Shop — any application that can
output printed 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.
- Set document viewing permissions (only
authorized users will see the document in their Document Menu).
- Set document editing/approval permissions.
- Automatically generate document headers
and footers with document control and approval information.
- Attach a user downloadable file to
any document (useful for templates and forms).
ISO SYSTEM MANAGEMENT Modules
Eight ISO System Management modules cover all QMS activities required in the ISO
13485 standard and QSR regulation, enabling you to create and operate a completely
paperless system. Common features for these modules include:
- User access control (deny, read only, and full access
permissions)
- Customizable data entry forms (can
change data field captions on forms)
- Export data to Excel for post processing
(statistical analysis, etc.)
- Automatically generated PDF reports
- Attachments
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 how to accomplish specific tasks. For example, how to establish new
users and assign permissions, how to manage and control documents, how to plan and
monitor internal audit cycles, how to customize reports, and so forth.
When you purchase the software bundled into the Complete System Software
Package you will also get plenty of help with establishing and implementing
the ISO 13485 system.
21 CFR Part 11 Compliance
ISOXpress software does not fully comply with requirements of 21 CFR Part 11 — Electronic
Records and Electronic Signatures. You can still use the software for managing your
quality system, as long as you print out, sign, and save all documents and records
in an 'archive' paper file. For a small company this may be the only choice. Part
11 compliant systems are simply too expensive.
Fortunately, the FDA is aware of this problem, and recognizes the, so-called, 'hybrid'
systems, where electronic records are printed on paper and are thus preserved and
archived (ref. Guidance for Industry — Part 11, Electronic Records; Electronic Signatures
— Scope and Application — August 2003). However, the exact interpretation of these
regulations and guidelines is not completely clear, so please be sure to investigate
for yourself what you need to do in your particular situation to comply with FDA
requirements. 'Hybrid' systems will always be more vulnerable to subjective
interpretations.
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