DEVIATION MANAGEMENT SYSTEM
A well-designed and implemented Deviation Management (DM) and
CAPA System offers a mechanism for obtaining critical quality data in a
timely manner to enable quick response to failures, early warning of
potential failures, and redeployment of resources to problematic areas. It
is one of the most valuable tools available to management to help
maintain a state of control.
Gail Bredehoeft, Judy OHara. 2009. BioPharm International. Volume 22,
Issue 4
HISPANIA SERVICES TOTAL DEVIATION MANAGEMENT
Hispania Services Total Deviation Management (HSTDM) is an easy
to use database that helps small to medium-size businesses to manage
their deviations (nonconformities, complaints, OOS, OOE, OOT) and CAPA
System in compliance with ISO, GHTF, IHC, & IFS, BRC, OHSAS & FDA
regulations and requirements.
HSTDM can be use to manage all types of deviations (nonconformities,
complaints, OOS, OOE, OOT) no matter where they originate (Audit,
Inspection, Customer Feedback, Mannufacturing, Laboratory, etc) or what
is the deviation subject (Document, Product, Equipment, OOS, etc).
HSTDM can be used by any Organization no matter the nature of its
activities.
The HSTDM database is based on a Risk-Based Approach to Deviation
Management and operates as per the PDCA (Plan-Do-Check-Act)
management methodology.
At its core HSTDM is a "CAPA System"-based database that makes easy
for the uninitiated user to manage all sorts of deviations (nonconformities,
complaints, OOS, OOE, OOT) that originate in an Organization.
No matter what Standard your Organization complies with (ISO, OHSAS,
IFS, BRC, GHTF, ICH, FDA), you can benefit from HSTDM to meet those
Standards requirements on: nonconformities management, CAPA System,
OOS, OOT, OOE, complaints management, incident management, defects
management, etc.
HSTDM is an intuive database than doesn't require training because it is
based on the way you usually handle all your deviations (nonconformities,
complaints, OOS, OOE, OOT) or CAPA System. Nevertheless, you can
count on the HSTDM User Guide to provide you all the necessary
information to use HSTDM from day one.
If your Organization has already a documented Deviation Managament
(DM) and CAPA System in place, HSTDM is the perfect tool to organize all
the documents of your DM & CAPA System.
HSTDM SOFTWARE REQUIREMENTS
The HSTDM management software tool is a FileMaker© based cross-
platform solution that runs both on Windows and Mac OS.
HSTDM is offered in two flavors:
•
Cross-platform solution. The HSTDM Database solution runs on both Windows and Mac OS.
•
The HSTDM Runtime Database solution does not require FileMaker Pro 11 on the user Windows-based PC.
•
Relational database.
•
Manage all your deviations, non conformities, complaints as per FDA regulations and ISO Management Systems requirements.
•
Streamline workflow: Deviation Identification --> Deviation Assessment --> Deviation Investigation --> CAPA --> Follow Up
•
Deviation management participants tasks assignment and tracking.
•
Email notification to Deviation management participants.
•
CAPA Action Items assignment and tracking.
•
CAPA Action Items verification and evaluation.
•
Deviation search / find.
•
Deviation detail and summary reports.
•
Deviation reports by year and quarter, deviation origin, deviation subject, and deviation root cause.
•
Database secured access by account name and password.
•
Account and password creation.
•
Record export.
•
Database sharing.
The HSTDM Runtime Database solution does not requiere FileMaker Pro 11 on the user PC and has been developed only for Windows OS (from Windows XP up to Windows 7). This option is for those users that do not have FileMaker Pro 11.
The HSTDM Database solution requires FileMaker Pro 11 on your Windows or Mac-based computer. This option is for those users that have FileMaker Pro 11.
Please notice that the HSTDM Runtime Database solution has several limitations like:
The HSTDM Database solution requires FileMaker Pro 11 on your Windows or Mac-based computer. This option is for those users that have FileMaker Pro 11.
Please notice that the HSTDM Runtime Database solution has several limitations like:
•
HSDM Runtime Database solution.
•
HSDM Database solution.
•
Runtime applications cannot be shared over a network.
•
Runtime applications do not include the ability to Save/Send Records as Adobe PDF files.
HSTDM KEY FEATURES
HSTDM main feaures are the following:
HSTDM main feaures are the following:
INTERESTED? ASK FOR ADDITIONAL INFORMATION
If you are interested in HSTMD and would like to know and see more about it, please contact us at CONTACT
PURCHASING HSTDM
How do I purchase HSTDM?
HSTDM is not available in a boxed version, it's only available as a download.
You can purchase HSTDM securely through this website.
We only accept PayPal payments.
PayPal Orders
PayPal orders are manually processed and it may take up to 8 hours before you receive the download link!
Once you make your order, you will receive an order confirmation email from PayPal. Please check your email spam filter, if you did not receive an order confirmation from PayPal.
Since orders are manually processed, depending on your "time zone", it make take several hours before you receive the download link!
Once the PayPal payment has cleared, a download link will be generated and e-mailed to you.
Click the PayPal Buy Now button to purchase HSTDM through PayPal.
If you are interested in HSTMD and would like to know and see more about it, please contact us at CONTACT
PURCHASING HSTDM
How do I purchase HSTDM?
HSTDM is not available in a boxed version, it's only available as a download.
You can purchase HSTDM securely through this website.
We only accept PayPal payments.
PayPal Orders
PayPal orders are manually processed and it may take up to 8 hours before you receive the download link!
Once you make your order, you will receive an order confirmation email from PayPal. Please check your email spam filter, if you did not receive an order confirmation from PayPal.
Since orders are manually processed, depending on your "time zone", it make take several hours before you receive the download link!
Once the PayPal payment has cleared, a download link will be generated and e-mailed to you.
Click the PayPal Buy Now button to purchase HSTDM through PayPal.
