The Benefits of Correspondence Management Systems for Formal Correspondence

There are very few industries that escape the regulatory grasp of the US federal government, EU agencies or other respective regulatory authorities. Compliance typically revolves around external communications with customers and regulatory agencies, and communications must be done in a very specific format. Companies that employ a correspondence management system for capturing and tracking incoming and outgoing formal correspondence are able to more effectively streamline their processes, improve efficiency, and keep regulators at bay. Here is how a viable correspondence management system can benefit organizations operating under strict regulatory requirements.

Adhering to regulatory compliance

Utilising a correspondence management tool can help avoid compliance headaches in industries with strict regulations. For example, in 2014 the 5th Annual Health Insurance Portability and Accountability Act (HIPPA) Breach Report recorded 164 protected health information (PHI) breaches, affecting around 9 million patients. In another example, Blue Cross of Tennessee ended up spending up to 18 million dollars in HIPAA fines in 2012 for violating privacy and security rules.

All these incidents boil down to one thing – effective management of formal correspondence. When it comes to the timely and accurate creation and distribution of correspondence, an effective correspondence management solution will support you and also enable you to archive everything for auditing purposes later on.

Correspondence management and FDA Complete Response Letters (CRL)

Let’s take a look at an example relating to FDA Complete Response Letters (CRLs). The U.S. Food and Drug Administration (FDA) sends Complete Response Letters to communicate it has completed its review of a drug application, but that it has decided that it will not approve it for marketing in its present form. Receiving one of these letters from the FDA is never good news. These regulatory bodies have very strict rules regarding marketing authorisation, therefore any organisation that ventures in the waters of pharma and life sciences will need an effective solution for managing this correspondence at some time or other.

Receiving a CRL is only half the battle. The information contained within the letter is where correspondence management plays a crucial role. Organisations are required to share this information with internal stakeholders, and publically-traded companies are also required to make the content of CRLs public. Complete Response Letters typically outline certain deficiencies and unmet criteria relating to a given product. Communicating that feedback quickly and clearly to stakeholders and traders is essential. In recent years, the best companies have demonstrated that if you are able to effectively share that information without leaving people in the blind, you stand a far better chance of retaining trust – and share price.

Correspondence management systems designed to support formal correspondence processes are best-equipped to help you respond swiftly in such cases and provide a multi-channel communication option. Companies that receive CRLs need to ensure they capture the right information, collect responses quickly and accurately, produce a compliant response document and share that information within the pre-defined time. In order to maintain honest and trusted communications, proper formal correspondence management plays a big part in this process.

Increase your bottom line with correspondence management

Non-compliance results in hefty fines, while delayed responses result in costly delays and late product launches. But it’s the little things that make the biggest impact on your bottom line. Responses that were formerly labour-intensive and difficult to produce accurately can be streamlined through automation and centralised management. The result is a significantly reduced risk of fines, and more importantly faster time-to-market and increased revenue opportunity.