Managing the creation, approval and final production of promotional materials for the pharmaceutical industry has traditionally been a cumbersome, time-consuming, paper-intensive process.
From the initial job request – once the drug name has been approved – to the last signature, marketing materials loop from legal to medical to regulatory affairs … and then onto the FDA for approval. The paper process cannot be tracked or improved upon, as there are no reporting tools. It’s all too common for a paper document pending review to “be lost” in someone’s inbox, losing valuable time.
APPROVE-PTS is built on the industry standard Microsoft SharePoint 2010 for ease of integration into all other collaborative and document management systems. APPROVE-PTS is also available for EMC Documentum.
Sitrof’s APPROVE-PTS Promotional Material Tracking System connects outside creative agencies, marketing teams and regulatory reviewers, allowing marketing materials to be reviewed, approved and published in the most efficient manner possible. Jobs are routed via built-in workflows with annotations and version control to retain full audit trail.
APPROVE-PTS reduces previously untrackable delays and logjams. Reviewers are notified via email that a job is waiting their review. Digital signatures with automatic date and time stamp ensure Title 21 CFR Part 11 compliance. Advanced reporting tools allow marketing communication specialists and administrators to collect thorough metrics to resolve delays and improve the process.
A full library of supporting materials such as studies and claims can be attached to the piece, creating a complete packet for reviewers and approvers. And those same supporting materials can be managed in a document repository for reuse across multiple marketing pieces. APPROVE-PTS also creates submission forms such as the FDA DDMAC Form 2253 to streamline the approval process.