All companies within Life Sciences face the challenge of responding to Health Authority questions in a timely but also consistent manner; everyone will be familiar with the scenario where a question in one language from one authority results in one answer, and the same or similar question from another authority in a different language will result in a second answer, without cross-referencing them, leading to at best wasted time and effort, and at worst answers that are different per region and can result in compliance issues.
Many Life Science companies still use out-dated processes for this; ones which may include keeping correspondence in a different system from the submission documents to which they refer, resulting in lack of searchability, traceability and incomplete business processes. These repositories make it difficult to truly interact with submissions (e.g. the ability to see every relevant document with one click) let alone provide good security, version control and audit trails, as well as compliance with 21 CFR Part 11 and similar regulations. To make matters worse, quite often affiliates use their own approach and systems leaving the company without adequate visibility as to the activities in local markets.
Industry leading companies need a centralised, purpose-built solutions for managing their regulatory correspondence. This kind of system gives a comprehensive view – meaning that a single click brings up all the relevant information and activity surrounding a submission. Some of the key benefits of a good system are:
• Reduction in re-work and overall time wasted
• Faster responses for a quicker time to market
• Seamless integration with RIM systems and regulatory submission documents
• Improved global visibility – know exactly what was submitted where and when, including local affiliate activities
• Advanced search options for to allow quick location of documents and HA questions / responses, including those in different languages
• Reporting and dashboards
The CARA Life Science Platform has all the functionality needed to make this process much simpler and more intuitive for you and your affiliates. Users benefit from out-of-the-box features such as
• ingestion of questions
• extraction of questions from emails and attachments with automatic translation into multiple languages
• automatic searching for similar questions and answers in multiple languages
• automatic routing of questions to the subject matter experts for creating answers if they don’t exist
• compilation of response documents from the answers
• relating of correspondence to your CARA RIM / submission documents (or other RIM / submission document systems)
• full reporting and tracking on progress of HA correspondence
The artificial intelligence capabilities of Google integrated into CARA allow further automations by reading the incoming correspondence and finding the more suitable response documents and sending them along with the incoming question to the inbox of the relevant user. This again shortens the response time and limits the danger of re-work and re-production of documents which already exist in the system.
To see how the CARA Life Science Platform allows you to manage the process, register now for our upcoming webinar: Health Authority Correspondence with CARA on 4th November 2020.