Step-by-Step Strategies for Effective REMS Audit Preparation

Posted on by globiox

Written by: Patti Rossman

Preparing for a REMS (Risk Evaluation and Mitigation Strategies) audit can be a daunting task, but with the right approach, it can be manageable and even straightforward. Whether you are a vendor or a service provider, ensuring compliance with REMS requirements is crucial for maintaining regulatory standards and delivering quality services. This list of seven essential steps will help you navigate the complexities of a REMS audit, from reviewing your Master Services Agreement to setting the stage for a successful audit day. With these practical tips, you can approach your next audit with confidence and ease.

  1. Review MSA 

One of the objectives of most REMS audits is to verify that the vendor is meeting their obligations detailed in a Master Services Agreement (MSA) and related Addenda and Statements of Work (SOW). The vendor being audited should review the relevant contractual documents and ask themselves 

    •  Are we meeting our obligations? 
    • What documents, records, SOPs, and other objective evidence can we show the auditor to demonstrate that we are meeting our obligations? 

Have objective evidence of meeting obligations ready to show the auditor if they ask.  

 

      2. Verify Regulations 

Some REMS-related functions and vendors are FDA regulated and some are not. As a vendor, know your status and be prepared to explain what regulations do and do not apply to the services you are performing or products you are supplying. Regulated REMS functions are those related to:  

    • Assessments of the REMS strategy 
    • Medication guide or patient package insert 
    • Communication plan to health care providers 
    • Elements to assure safe use (EASU) 
    • Software used to implement regulated REMS functions 

If a service that the vendor performs (for example: program management) is not a regulated REMS function, it is not necessary for that vendor to comply with any particular regulations unless specified contractually. 

 

      3. Obtain Agenda 

An agenda obtained from the auditor should provide information about: 

    • Dates and times for the audit 
    • Scope of the audit 
    • Relative time allotted to each audit topic 

 

      4. Clarify Scope 

If an audit topic is not clear or does not seem relevant, contact the auditor to clarify the scope of the audit. The auditor may have outdated information about the services or products being provided. 

 

      5. Prepare Introduction 

A presentation to orient the auditor to the REMS functions being performed is very helpful, but it should not be a company marketing presentation.

The auditor will be most interested in:  

    • A summary of the company’s services and products, facilities’ locations and sizes (number of staff), and corporate structure (especially in REMS-related areas). 
    • Key staff performing REMS-related functions, their titles, roles, and responsibilities 
    • A short history of the vendor’s participation in the REMS program 
    • History of Regulatory inspections and outcomes 
    • If audited previously, changes made since last audit (including changes in policies, procedures, processes, software, key staff, facilities).   

 

      6. Set the Stage 

Recommendations for preparation for the actual audit include: 

    • For on-site audits:
      • Lodging and transportation (including airport(s), recommendations for the auditor(s), auditing room reservations, plans for provision of refreshments and lunch (if providing lunch ask auditors for dietary restrictions), parking instructions, and building access instructions.
      • It is important to give auditor(s) ample room for their laptop, notes, and documents/records being examined. If there is more than one auditor and they are auditing different topics, they may each require a separate room to discuss and conduct interviews.  
    • For remote audits:
      • Upload requested documents to a secure, shared site that the auditor(s) can access. Many auditors will ask for an Organization Chart, Table of Contents of procedures, list of software applications used in fulfillment of REMS obligations, objective evidence from previous audit observations where the auditor needs to verify completion of the corrective action, relevant MSA, addenda, and SOWs, and other information before the start of the audit.  

Alert lead staff as to when their participation in the audit may be needed.  

 

      7. RELAX! 

You got this! Auditors are people. They may misunderstand, make mistakes, or not ask for a critical document that shows your compliance.

Have conversations, ask questions, and hopefully, learn something. At least that is how Globiox auditors roll.