If your company is operating with a paper-based or makeshift promotional review process, you may think you’re getting by okay. After all, you’re reviewing claims, approving materials, and distributing content to your reps.
However, with your makeshift process comes inherent risk of non-compliance. For example:
- Does your system comply with FDA 21 CFR Part 11 guidelines for e-signatures?
- Have all reviewers approved the promotional materials and confirmed that they have a “balance between efficiency and risk information, avoid false and misleading statements, and reveal material facts about the product being promoted, including facts about consequences that may result from use?”
- Are you confident your sales reps are using the final, approved materials and no longer have access to expired content?
If you’re caught out of compliance, there can be some serious sanctions by governing bodies like the FDA and FTC such as:
- FDA untitled and warning letters, which can tarnish a brand’s reputation
- Sanctions that include a Corrective and Preventive Action (CAPA), which requires significant time and effort from your team to complete, and puts other work on hold
- Financial penalties
Ensuring promotional review process compliance is important for life science organizations, but staying compliant doesn’t have to be overly-complicated. Here are four common compliance pitfalls and strategies you can start using today to get back on track.
Pitfall #1: Missed feedback and inadequate approvals
If you’re not following a uniform process for reviewing and approving content, you’re more likely to miss feedback, fail to secure the right reviews from the right team, or forget to capture approval altogether. Inefficient review processes make it difficult to feel confident that all feedback has been addressed.
Strategies to enforce compliance:
- Establish and enforce a clear process for reviews and approvals, including a procedure for how material will be distributed for review, how and where feedback will be captured, and how updates will be distributed for re-review.
- Ensure your process includes a step for vetting all claims made and recording which reference documents are being sourced.
- Systematically track and store approvals on all materials to ensure all required groups approve materials prior to use.
Pitfall #2: Improper material usage
If your sales reps are unclear on where to find final, approved materials and are not notified when new versions are available, it can lead to improper use of expired or draft content.
Strategies to enforce compliance:
- Establish procedures to ensure proper version control as materials are superseded or expired. Integrating with a sales enablement tool is an easy way to ensure the reps are only using the most recent, approved materials.
- Establish a central repository to store materials available for use.
Pitfall #3: Not adhering to SOPs
It’s important to move quickly to get your regulated content to market, but circumventing steps in your review process or skipping steps altogether can lead to huge compliance risks.
Strategies to enforce compliance:
- Use a workflow system that enforces SOP adherence and does not allow for circumventing the predefined steps.
- If you find that there are unnecessary steps in your process, consider modifications to your SOP to ensure compliance.
Pitfall #4: Inadequate and inefficient audit preparations
If you’re not capturing signatures or securing approvals on your materials (or properly storing approval information for easy retrieval), you risk non-compliance and a nightmare should you be audited.
Strategies to enforce compliance:
- Leverage a system that automatically captures eSignatures in accordance with FDA 21 CFR Part 11 guidelines.
- Automatically capture audit records in a central location for easy audit retrieval.
The easiest way to stay compliant
Executing on the strategies above is dramatically easier when you enlist the right tools: such as a promotional review system. A promotional review system, like Pepper Flow, allows you to achieve a fast, efficient review process and mitigate any compliance risk with functionality such as:
- Automated workflow routing to ensure adherence to SOPs and appropriate approvals
- E-signatures in compliance with FDA and EU guidelines
- Systematic audit records for fast audit preparations
- Document version control
- Integrations with your sales enablement tool to ensure only final, approved content is accessible by your reps
- Real-time annotations and commentary directly on the materials to ensure all feedback is captured and addressed