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The way a company communicates with regulatory bodies – be it responding to a complaint or regular submissions – plays a key role in meeting compliance requirements. For instance, in the case of a complaint, the company must take full responsibility to address the concern raised, provide relevant justification, and most importantly share details on what the company will do in terms of corrective and preventive actions.

The first step to doing this well is to have a robust document management system in place. Also, effective compliance writing is a learned skill that takes practice and an understanding of regulatory expectations.

Document Management

Key Elements of a Good Regulatory Response

For the sake of this blog, let us stick with the case of providing a regulatory response to a complaint from a customer and then reporting it to relevant regulators.

An enterprise that truly cares about compliance will handle the complaint with responsibility, showcase to the authorities how the SOP is set up, and instill confidence that the complaint is handled with care. Some of the points to keep in mind while drafting a response are —

  • Tone – Convey a sense of urgency in taking corrective actions.
  • Evidence – Rely on facts rather than opinions.
  • Action – Layout a corrective and preventive action plan. Ensure all necessary information is included in the response.
  • Timeline – Ensure dates committed to are feasible and achievable.
  • Justification – Plausible/scientific reasons for what caused the complaint. Clearly define and document the situation at hand.
  • Address compliant – Address problems as presented. Respond to each part of the complaint.
  • Guarantee – Express a desire to commit to long-term quality. Follow the company’s SOPs.

The above six aspects are applicable to any regulatory document. Make it clear, concise and to the point, yet leave nothing unaddressed. Good documentation is the key for effective collaboration.

Red Flags to Avoid

To prevent any painful regulatory consequence, a few red flags must be avoided at any cost. These include —

  • Failure to gather required information and document all the facts
  • Make assumptions based on past experiences
  • Make commitments that cannot be fulfilled
  • Make promises that will take months to complete without a rationale for the length of time
  • Only provide fixes for the specific issues and ignore preventive actions
  • An arrogant or over apologetic tone

A Few Thumb Rules for Effective Complaint Documentation

Writing a response is an important task. Tone, due diligence, and provisions made to resolve the issue are critical to the regulatory body accepting the response. Here are some of the rules to be followed:

  • Identify the issue – If a piece of machinery created the issue, it is important to incorporate the details of what part of the equipment failed. Pay attention to the minute details and document everything.
  • Identify the root cause – Once the issue is identified, the next necessary steps taken should also be part of the compliance response document. It shows the FDA (or any other regulator) that the company did an audit before responding.
  • Ask key questions – A good document is created to communicate facts and not vent frustration. Ask questions like ‘Would the company want the FDA to see it?’ ‘Would it affect the company if this response is read to family or a jury?’ ‘Would the document be suitable to be issued with the CEO’s signature?’ These questions help avoid problematic phrases or language. The document may not be for a regulator, but keep in mind that once a document is created, you never know who’ll read it.
  • Showcase the company’s ability to fix its own problems – Instead of complaining about which department is at fault, it is recommended to show FDA that the company can find and fix its own problems.
  • Highlight new steps taken such as tracking and trending process – FDA or any other regulatory body would want to know that the complaint is not treated as a one-time event. Showing that a track and trend process is implemented implies that the company has put in place procedures to avoid repeating mistakes.

A Few Best Practices

Handling written communication to address regulatory concerns must be dealt with diligently. Here are some of the best practices to adopt while creating these responses.

  • Think about the distribution of the document
  • A complaint from the regulatory body must be responded to with honesty and responsibility and not with sarcasm or humor.
  • Words such as ‘always’, ‘on purpose’, and inflammatory languages must be avoided at all costs.
  • If the problem will take a while to resolve, explain the circumstances while detailing the course of action that will be taken.
  • Refrain from responding to a complaint unless there is a clear picture of what has happened. Speculating shows the regulatory body that the organization is not aware of the issues present.
  • Do not exaggerate or use flippant comments that cannot be justified.
  • Watch CYA statements (Google this up, if you like!)
  • Close loops

ComplianceQuest Complaint Management Solution

With CQ Complaint Management Solution, medical device companies can have comprehensive control over how customer complaints are collected, tracked, and addressed while adhering to industry guidelines and regulations. ComplianceQuest is a registered FDA Transaction Partner for eMDRs and supports the latest XML, ICSR R2, HL7 R3, and AS2 protocol with client digital certificates.

To automate and streamline your documentation and complaint handling workflow, visit:
https://www.compliancequest.com/complaint-management-system/

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