Compliance is not the enemy, but an opportunity

Jul 17, 2012

With the regulatory environment as complex as it is, compliance is as hot a topic as it’s ever been. Between HIPAA privacy concerns, FDA regulations and recent news headlines, company executives are beginning to systematically incorporate compliance into planning for overall performance, value, and profitability, rather than viewing compliance as an end in itself. The issue at stake though is to plan for the operation of new business developments and enable strategies to be put in place that will not only save time and money, but also will ensure that the business is operating within legal boundaries.

There is a shift from previous views that process and compliance adds unneeded costs and time. Not many people are screaming from the mountaintops that we need more regulations so that they can reduce costs, but that does not mean that compliance increases costs.  Anyone who has  destroyed valuable pharmaceutical products due to improper storage, been late to market with a new therapy drug because clinical trials were delayed as a result of incomplete documentation, or has had to pay for high freight claims can attest, an upfront investment in testing, process and long term monitoring programs can be a cost savings for your company in the long run.

If you have not had to deal with litigation, claims or improper customs documentation, consider yourself lucky. With issues like tainted meats and improperly stored vaccines hitting the headlines, consumers are beginning to take notice. In the end, this will impact the bottom line. Fox News recently reported that improper vaccine storage at pharmacies and doctor’s offices has resulted in potential health risk for consumers. And this is many months after the product left the manufacturing facility. So what is the answer?

It’s simple. Invest now, or pay later. Internal customer studies find that logistics and packaging experts, who design packaging and processes around compliance requirements, actually reduce costs over time. How they do this varies by customer and product, however, the data generally shows that investing decisions made on precise data, in fact, avoid costly over engineering of packaging. At ShockWatch, we do this by using our calibrated indicators and recorders to conduct performance qualification, stability studies, gap analysis, warehouse mapping or lane mapping before finalizing packaging and logistics processes. After the testing process, indicators are used to monitor products long after they leave the facility.

When combined with an education program, process controls and cost reduced packaging, many customers find that losses due to impact damage or temperature excursions are reduced 40- 60%. For most companies, that is a substantial gain to their bottom line and keeps your company out of the headlines.