SPL Validation Tool

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 available on the web.

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.

FOR TESTING ONLY - SUBMITTING AN SPL FILE OR PACKAGE TO THE VALIDATOR DOES NOT CONSTITUTE A SUBMISSION TO THE FDA.

The Validator is an easy to use web-based application with the following basic functions:

  • Validate a single SPL file.
  • Validate a ZIP pakache consisting of the SPL document and all associated images.

The validator is being kept up to date with the most recent validation procedures and its associated terminology validation resources

FOR TESTING ONLY - SUBMITTING AN SPL FILE OR PACKAGE TO THE VALIDATOR DOES NOT CONSTITUTE A SUBMISSION TO THE FDA.

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.

FOR TESTING ONLY - SUBMITTING AN SPL FILE OR PACKAGE TO THE VALIDATOR DOES NOT CONSTITUTE A SUBMISSION TO THE FDA.

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 assistance, 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.