Annual Product Review

Automate your Annual Product Review (APR) business process using MARS

ANNUAL PRODUCT REVIEW

Annual Product Review reports scheduling, management and distribution processes within organizations have been fairly ad-hoc, linear and rigid utilizing a combination of localized tools, manual steps and knowledge base from individual resources. Changing regulations in different countries, new product registrations (and withdrawals) and resource turn-over introduces tremendous challenges to organizations to ensure global regulatory commitments to agencies are met in time. The lack of centralized system or knowledge base does not offer capabilities to optimize worldwide reporting thereby increasing the overall number of reports. This increases the cost and resource needs within organizations.

Quartica’s solution can help manage the end-to-end process reporting process from scheduling to distribution and tracking of compliance metrics. The solution integrates regulatory knowledge base, company product portfolio and internal company processes to provide a centralized system. It provides automated, agile and proactive tools to organizations by reducing overall reports and ensuring regulatory commitments are met on time in a cost effective manner.

Benefits

Automate scheduling and planning of APR reports.

Automate authoring of annual product review (APR) reports

Configuration tailored to organization internal standards and external regulations.

Tracking and measurement of overall compliance, delays, CAPA and overdue reports.

Ready to automate your APR business process?

Key Features

Manage end-to-end reporting process including planning, scheduling, report authoring and submission tracking.
Generate reporting obligations worldwide based on product portfolio.
Optimize reporting plans utilizing harmonization strategies to reduce total overall reports.
Manage Review and Approval workflow process.
Ensure conformance to standards, templates and regulations.

Estimate resource and budget needs based on upcoming submissions and approvals
Configure organizational specific strategies to fine tune reporting plans.
Generate reports on variance in expected timelines and actual timelines for different levels of management.
Collaborate with partners and local affiliates.
Track decision log, review and approval history.

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12. LIMITATIONS OF LIABILITY. QUARTICA DOES NOT ASSUME ANY RESPONSIBILITY, OR WILL BE LIABLE, FOR ANY DAMAGES TO, OR ANY VIRUSES THAT MAY INFECT YOUR COMPUTER, TELECOMMUNICATION EQUIPMENT, OR OTHER PROPERTY CAUSED BY OR ARISING FROM YOUR ACCESS TO, USE OF, OR BROWSING THIS WEBSITE OR USING THE SERVICES, OR YOUR DOWNLOADING OF ANY INFORMATION OR MATERIALS FROM THIS WEBSITE. IN NO EVENT WILL QUARTICA, OR ANY OF ITS OFFICERS, DIRECTORS, EMPLOYEES, SHAREHOLDERS, AFFILIATES, AGENTS, SUCCESSORS OR ASSIGNS, NOR ANY PARTY INVOLVED IN THE CREATION, PRODUCTION OR TRANSMISSION OF THE WEBSITE, BE LIABLE TO YOU OR ANYONE ELSE FOR ANY INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, THOSE RESULTING FROM LOST PROFITS, LOST DATA OR BUSINESS INTERRUPTION) ARISING OUT OF THE USE, INABILITY TO USE, OR THE RESULTS OF USE OF THE WEBSITE, OR THE MATERIALS, INFORMATION OR SERVICES CONTAINED ON ANY OR ALL OF THE WEBSITE, WHETHER BASED ON WARRANTY, CONTRACT, TORT OR ANY OTHER LEGAL THEORY AND WHETHER OR NOT ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING LIMITATIONS OF LIABILITY DO NOT APPLY TO THE EXTENT PROHIBITED BY LAW. PLEASE REFER TO YOUR LOCAL LAWS FOR ANY SUCH PROHIBITIONS. IN THE EVENT OF ANY PROBLEM WITH THE WEBSITE OR ANY MATERIALS, INFORMATION OR SERVICES CONTAINED ON ANY OR ALL OF THE WEBSITE, YOU AGREE THAT YOUR SOLE REMEDY IS TO CEASE USING THE WEBSITE AND SERVICES. IN NO EVENT SHALL QUARTICA’S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE), OR OTHERWISE EXCEED THE GREATER OF (A) TWENTY FIVE DOLLARS (US $25.00) OR (B) THE VALUE OF THE SERVICES PURCHASED OR SUBSCRIBED BY YOU ON THE WEBSITE.
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14. Release. In the event that you have a dispute with one or more other users of the Website, you release Quartica (and our officers, directors, agents, subsidiaries, joint ventures and employees) from claims, demands and damages (actual and consequential) of every kind and nature, known and unknown, suspected and unsuspected, disclosed and undisclosed, arising out of or in any way connected with such disputes.
15. Termination. You or we may suspend or terminate your account or your use of this Website or access to the Services, at any time, for any reason or for no reason. You are personally liable for any orders placed or charges incurred through your account prior to termination. We may also block your access to our Website and/or the Services in the event that (a) you breach these Terms of Service; (b) we are unable to verify or authenticate any information you provide to us; or (c) we believe that your actions may cause financial loss or legal liability for you, our users or us.
16. Force Majeure. Neither Quartica nor you shall be responsible for damages or for delays or failures in performance resulting from acts or occurrences beyond their reasonable control, including, without limitation: fire, lightning, explosion, power surge or failure, water, acts of God, war, revolution, civil commotion or acts of civil or military authorities or public enemies: any law, order, regulation, ordinance, or requirement of any government or legal body or any representative of any such government or legal body; or labor unrest, including without limitation, strikes, slowdowns, picketing, or boycotts; inability to secure raw materials, transportation facilities, fuel or energy shortages, or acts or omissions of other common carriers.
17. Privacy. Quartica’s data collection and use practices, including data collection and use of personally identifiable information can be found in Quartica’s Privacy Policy.
18. Dispute Resolution. PLEASE READ THE FOLLOWING ARBITRATION AGREEMENT IN THIS SECTION (“ARBITRATION AGREEMENT”) CAREFULLY. It requires you to arbitrate disputes with Quartica and limits the manner in which you can seek relief from us.
  - Applicability of Arbitration Agreement. You agree that any dispute or claim relating in any way to your access or use of the Services or to any aspect of your relationship with Quartica, will be resolved by binding arbitration, rather than in court, except that (1) you may assert claims in small claims court if your claims qualify, and (2) you or Quartica may seek equitable relief in court for infringement or other misuse of intellectual property rights (such as trademarks, trade dress, domain names, trade secrets, copyrights, and patents). This Arbitration Agreement shall apply, without limitation, to all claims that arose or were asserted before the Effective Date of these Terms or any prior version of these Terms.
  - Arbitration Rules and Forum. The Federal Arbitration Act governs the interpretation and enforcement of this Arbitration Agreement. To begin an arbitration proceeding, you must send a letter requesting arbitration and describing your claim to our registered agent, National Registered Agents, Inc. 155 Federal Street; Suite 700, Boston, MA 02110. The arbitration will be conducted by JAMS, an established alternative dispute resolution provider. Disputes involving claims and counterclaims under $250,000, not inclusive of attorneys’ fees and interest, shall be subject to JAMS’s most current version of the Streamlined Arbitration Rules and procedures available at https://www.jamsadr.com/rules-streamlined-arbitration/; all other claims shall be subject to JAMS’s most current version of the Comprehensive Arbitration Rules and Procedures, available at https://www.jamsadr.com/rules-comprehensive-arbitration/. JAMS’s rules are also available at www.jamsadr.com or by calling JAMS at 800-352-5267. If JAMS is not available to arbitrate, the parties will select an alternative arbitral forum. If the arbitrator finds that you cannot afford to pay JAMS’s filing, administrative, hearing and/or other fees and cannot obtain a waiver from JAMS, Quartica will pay them for you. In addition, Quartica will reimburse all such JAMS’s filing, administrative, hearing and/or other fees for claims totaling less than $10,000 unless the arbitrator determines the claims are frivolous. You may choose to have the arbitration conducted by telephone, based on written submissions, or in person in the country where you live or at another mutually agreed location. Any judgment on the award rendered by the arbitrator may be entered in any court of competent jurisdiction.
  - Authority of Arbitrator. The arbitrator shall have exclusive authority to (a) determine the scope and enforceability of this Arbitration Agreement and (b) resolve any dispute related to the interpretation, applicability, enforceability or formation of this Arbitration Agreement including, but not limited to any claim that all or any part of this Arbitration Agreement is void or voidable. The arbitration will decide the rights and liabilities, if any, of you and Quartica. The arbitration proceeding will not be consolidated with any other matters or joined with any other cases or parties. The arbitrator shall have the authority to grant motions dispositive of all or part of any claim. The arbitrator shall have the authority to award monetary damages and to grant any non-monetary remedy or relief available to an individual under applicable law, the arbitral forum’s rules, and these Terms (including the Arbitration Agreement). The arbitrator shall issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The arbitrator has the same authority to award relief on an individual basis that a judge in a court of law would have. The award of the arbitrator is final and binding upon you and us.
  - Waiver of Jury Trial. YOU AND COMPANY HEREBY WAIVE ANY CONSTITUTIONAL AND STATUTORY RIGHTS TO SUE IN COURT AND HAVE A TRIAL IN FRONT OF A JUDGE OR A JURY. You and Quartica are instead electing that all claims and disputes shall be resolved by arbitration under this Arbitration Agreement, except as specified in Section 18.1(a) above. An arbitrator can award on an individual basis the same damages and relief as a court and must follow these Terms as a court would. However, there is no judge or jury in arbitration, and court review of an arbitration award is subject to very limited review.
  - Waiver of Class or Other Non-Individualized Relief. ALL CLAIMS AND DISPUTES WITHIN THE SCOPE OF THIS ARBITRATION AGREEMENT MUST BE ARBITRATED ON AN INDIVIDUAL BASIS AND NOT ON A CLASS OR COLLECTIVE BASIS, ONLY INDIVIDUAL RELIEF IS AVAILABLE, AND CLAIMS OF MORE THAN ONE CUSTOMER OR USER CANNOT BE ARBITRATED OR CONSOLIDATED WITH THOSE OF ANY OTHER CUSTOMER OR USER. If a decision is issued stating that applicable law precludes enforcement of any of this subsection’s limitations as to a given claim for relief, than then claim must be severed from the arbitration and brought into the State or Federal Courts located in the Commonwealth of Massachusetts. All other claims shall be arbitrated.
  - 30-Day Right to Opt Out. You have the right to opt out of the provisions of this Arbitration Agreement by sending written notice of your decision to opt out to privacy@quartica.com within 30 days after first becoming subject to this Arbitration Agreement. Your notice must include your name and address, your Quartica username (if any), the email address you used to set up your Quartica account (if you have one), and an unequivocal statement that you want to opt out of this Arbitration Agreement. If you opt out of this Arbitration Agreement, all other parts of these Terms will continue to apply to you. Opting out of this Arbitration Agreement has no effect on any other arbitration agreements that you may currently have, or may enter in the future, with us.
  - Severability. Except as provided in subsection 18.1(e), if any part or parts of this Arbitration Agreement are found under the law to be invalid or unenforceable, then such specific part or parts shall be of no force and effect and shall be severed and the remainder of the Arbitration Agreement shall continue in full force and effect.
  - Survival of Agreement. This Arbitration Agreement will survive the termination of your relationship with Quartica.
  - Modification. Notwithstanding any provision in these Terms to the contrary, we agree that if Quartica makes any future material change to this Arbitration Agreement, you may reject that change within thirty (30) days of such change becoming effective by writing Quartica to privacy@quartica.com.
19. General. Any claim relating to, and the use of, this Website, the Services and the materials contained herein is governed by the laws of the Commonwealth of Massachusetts. You consent to the exclusive jurisdiction of the state and federal courts located in Suffolk County, Massachusetts. A printed version of these Terms of Service will be admissible in judicial and administrative proceedings based upon or relating to these Terms of Service to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. We do not guarantee continuous, uninterrupted or secure access to our Website or the Services, and operation of the Website may be interfered with by numerous factors outside of our control. If any provision of these Terms of Service is held to be invalid or unenforceable, such provision shall be struck and the remaining provisions shall be enforced. You agree that these Terms of Service and all incorporated agreements may be automatically assigned by Quartica in our sole discretion. Headings are for reference purposes only and in no way define, limit, construe or describe the scope or extent of such section. Our failure to act with respect to a breach by you or others does not waive our right to act with respect to subsequent or similar breaches. These Terms of Service set forth the entire understanding and agreement between us with respect to the subject matter hereof. All sections which by their context ought to survive this agreement shall survive any termination or expiration of this Agreement.
20. Entire Agreement. These terms and conditions are the entire agreement between the user and Quartica and supersede any prior understandings or agreements (written or oral).
21. Additional Assistance. If you do not understand any of the foregoing Terms of Service or if you have any questions or comments, we invite you to contact our Customer Service Department by email at support@quartica.com.
22. Copyright Notice. All Website design, graphics, text selections, arrangements, and all software are Copyright © 2019, Quartica, Inc. or its licensors. ALL RIGHTS RESERVED.

Last Changes to Terms of Service: February 15, 2019

Annual Product Review

Annual Product Overview

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MARS Platform