Pragmatic Data LLC is pleased to announce the release of the
Pragmatic Validator™, a conformance validation tool for Structured
Product Labels (SPL) submissions. The Pragmatic Validator checks SPL
submissions for W3C XML Schema conformance, and conformance to the FDA
conformance rules set forth in the "SPL Validation Procedures for Establishment Registration and Drug Listing " and using a schematron approach to detailed validation of XML documents.
The Pragmatic Validator is available as a service as well as a
downloadable software package which can be run on the user's local
machine.
The present release of the Validator is 1.1 beta. This means the validator has passed tesing on a number of SPL documents and has discovered common problems on them. At this time we are making the Validator available to the broader community of SPL submitters and reviewers.
The Validator is an easy to use web-based application with the following basic functions:
The validator is being kept up to date with the most recent validation procedures and its associated terminology validation resources
Files submitted for validation are stored temporarily on the Pragmatic Data LLC's servers. The files are not archived by Pragmatic Data and the system has no function intended to allow you, the user, Pragmatic Data, FDA, or anyone else to browse or retireve the files which you submit. Validation rules which pertain to data from other SPL submissions or databases are not checked.
By using the Pragmatic Validator, you argee to the following terms and conditions of use:
Terms and Conditions for using the Pragmatic Validator Service
PRAGMATIC DATA LLC. IS PROVIDING THIS VALIDATION SERVICE
UNDER THE TERMS AND CONDITIONS DETAILED BELOW. BY USING THIS
SERVICE YOU ARE AGREEING WITH THESE TERMS OF USE.
No Warranty
DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED IN
THIS AGREEMENT, PRAGMATIC DATA AND ITS LICENSORS AND
SUPPLIERS DISCLAIM ALL WARRANTIES, CONDITIONS,
REPRESENTATIONS, INDEMNITIES AND GUARANTEES WITH RESPECT TO
THIS SERVICE, WHETHER EXPRESS OR IMPLIED, ARISING BY LAW,
CUSTOM, PRIOR ORAL OR WRITTEN STATEMENTS OR OTHERWISE
(INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON-INFRINGEMENT). BY WAY OF EXAMPLE
AND NOT IN LIMITATION, NEITHER PRAGMATIC DATA NOR ITS
LICENSORS OR SUPPLIERS WARRANTS THAT: (i) USE OF THE SERVICE
OR ANY PART THEREOF WILL BE UNINTERRUPTED OR ERROR FREE; (ii)
ALL DEFECTS IN THE SERVICE WILL BE CORRECTED; OR (iii) THE
SERVICE WILL OPERATE IN THE COMBINATIONS THAT MAY BE SELECTED
BY YOU. TO THE EXTENT THAT PRAGMATIC DATA OR ITS LICENSORS
OR SUPPLIERS CANNOT DISCLAIM A WARRANTY AS A MATTER OF
APPLICABLE LAW, THE SCOPE AND DURATION OF SUCH WARRANTY WILL
BE THE MINIMUM PERMITTED UNDER SUCH LAW.
LIMITATION OF LIABILITY. IN NO EVENT WILL
PRAGMATIC DATA OR ITS LICENSORS OR SUPPLIERS BE LIABLE FOR
ANY INCIDENTAL, SPECIAL, INDIRECT, CONSEQUENTIAL, OR PUNITIVE
DAMAGES OF ANY CHARACTER ARISING OUT OF OR IN CONNECTION WITH
THIS AGREEMENT OR THE SERVICE, REGARDLESS OF THE LEGAL THEORY
ASSERTED, WHETHER BASED ON BREACH OF CONTRACT, BREACH OF
WARRANTY, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY, OR
OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES
AND EVEN IF A REMEDY SET FORTH HEREIN IS FOUND TO HAVE FAILED
OF ITS ESSENTIAL PURPOSE. THE AGGREGATE AND TOTAL LIABILITY
OF PRAGMATIC DATA AND ITS LICENSORS AND SUPPLIERS FOR ANY AND
ALL CLAIMS ARISING OUT OF THIS AGREEMENT WILL BE LIMITED TO
DIRECT DAMAGES AND WILL NOT EXCEED THE AMOUNT ACTUALLY PAID
BY YOU FOR THE SERVICE THAT CAUSED THE DAMAGES
LIMITATION OF LIABILITY FOR VALIDATOR. While
the Pragmatic Validator Service provides validation functions
for conformance of SPL labels with published conformance
rules, it is virtually impossible to guaranty that each and
every non-conformance situation can be forseen or detected.
THEREFORE, PRAGMATIC DATA EXPRESSLY DISCLAIMS ALL WARRANTY
THAT THE PRAGMATIC VALIDATOR SERVICE PRODUCT WILL DETECT ANY
PARTICULAR CONFORMANCE VIOLATION OR PROVIDE ANY PARTICULAR
AMOUNT OF WARNING OF A POSSIBLE NON-CONFORMANCE OF A EXAMINED
SPL LABEL.
Ownership and Confidentiality
Proprietary Rights. All trademarks, service
marks, patents, copyrights, trade secrets and other
intellectual property rights in the Software (collectively,
"Materials") are and will remain the exclusive property of
Pragmatic Data or its licensors or suppliers, whether or not
specifically recognized or perfected under applicable local
law. You will not create derivative works of, modify,
assign, sublicense, sell, rent, reverse engineer, disassemble
or decompile the Materials. Any rights not expressly granted
herein are reserved to Pragmatic Data or its licensors or
suppliers. Pragmatic Data or its licensors or suppliers will
own all rights in all derivative works of the Materials and
any copy, translation, modification, adaptation or derivation
(including any improvement or development) of the Materials.
You will not take any action that jeopardizes Pragmatic
Data's or its licensors' or suppliers' proprietary rights in
the Materials or acquire any right in the Materials.
Confidential Information. Confidential
Information means all information that is proprietary to
You or to Pragmatic Data or its licensors or suppliers.
Confidential Information does not include: (i) information
that is made generally available to the public without
obligation of confidentiality; (ii) information that the
receiving party can show through documentation was
independently developed by the receiving party without use of
Confidential Information of the disclosing party; or (iii)
information that is disclosed pursuant to a requirement of a
court, government agency, or law, including without
limitation, state and federal securities laws; provided that,
if the receiving party is required by a court, government
agency, or applicable law to disclose any Confidential
Information of the disclosing party, the receiving party will
notify the disclosing party immediately upon learning of such
requirement so that the disclosing party has an opportunity
to take action to protect the confidentiality and proprietary
nature of the Confidential Information. The Software is
Confidential Information of Pragmatic Data.
Nondisclosure. Each party receiving
Confidential Information of the other party will take
reasonable precautions necessary to safeguard the
confidentiality of the disclosing party's Confidential
Information, including at a minimum, the precautions taken by
the receiving party to protect its own Confidential
Information. Neither party will disclose the other party's
Confidential Information in whole or in part to any third
party except to employees or consultants who require access
to the Confidential Information, provided that any such
employees and consultants agree in writing to maintain the
information in confidence. Neither party will remove or
deface, or allow the removal or defacement, of any
confidential or proprietary notice placed on any Confidential
Information of the other party.
General
Governing Law. This Agreement will be
governed by and construed in accordance with the laws of
Indiana, U.S.A, as applied to agreements entered into and to
be performed entirely within the state of Indiana without
regard to conflicts of laws provisions thereof, the Uniform
Commercial Code as adopted in Indiana or the United Nations
Convention on Contracts for the Sale of Goods.
Legal Actions. You hereby consent to
the personal jurisdiction and venue of the courts of the
State of Indiana. Any legal or equitable claim of any nature
arising hereunder will be filed and maintained in the state
or federal courts in the State of Indiana and You agree
that such courts are a convenient forum for adjudication.
The prevailing party in any legal action arising hereunder
will be entitled to its costs of litigation and reasonable
attorneys' fees as to that part of the litigation for which
it prevails.
English Language; Headings. Pragmatic Data
and You confirm that it is their wish that this
Agreement as well as other documents relating hereto,
including notices, have been and will be drawn up in the
English language only. The headings of this Agreement are
inserted only for convenience and will not be construed as a
part of this Agreement.
Entire Agreement. This Agreement including
its exhibits is the complete and exclusive statement of
agreement concerning the subject matter hereof and supersedes
all prior understandings and other communications between the
parties relating hereto. This Agreement may be amended only
by a subsequent writing that specifically refers to this
Agreement and that it is signed by both parties.
Proceed to the Validator
If you agree to the conditions of use set forth above, you may proceed to the
Online Pragmatic Validator Service.
The validator output is easy to browse and provides explanations for all detected errors. The validation services are available for free as is. If you need additional assistence, Pragmatic Data LLC provides SPL consulting services and also additional software which help you maintain complience to the latest validation rules and an efficient submission process. Contact us for inquiry about these additional services.