Prepare for the FDA’s Test of Quality
Inspections by the US Food and Drug Administration (FDA) are not new to regulated industries and laboratories, as are compliance, enforcement, and criminal investigations. With the goal of addressing and minimizing significant health risks, an FDA inspection can either make or break a company, making a good and lasting impression or tarnishing its image, costing the company time, money, and business. For pharmaceuticals, laboratories, biotech leaders, and drug companies, proving quality systems is paramount.
Access to FDA guidelines and regulations is only the beginning. To achieve a five-star rating, pharmaceutical industry manufacturers and suppliers need to understand what FDA inspectors are looking for and how to respond to enforcement measures in a timely and effective manner.
Conversion to Electronic Health Records Can Be Challenging
The introduction of the electronic health record (EHR) ushered in a new era as health care went digital over the past decade. The plan was to digitize patient medical histories in order to enhance professional collaboration, improve patient care, reduce system-wide costs, and other benefits.
Today, the original aims and promises of the EHR system are in question. Debates are stirring regarding the safety and security of electronic health records while limitations of the system itself are surfacing.
Pharmacists Go Beyond Dispensing Drugs
Global forces, advances in telecommunications, and the age of mobility and consumerism have combined to revolutionize the health-care system. What used to be a closed and isolated system of key players—doctors, pharmaceutical companies, insurance companies, and medical device firms—has been cracked open. If patients were traditionally the passive recipients of physician care and treatment, today they are active consumers willing to pay for their own health care and seeking the people, technologies, tools, and partnerships that will best serve them.
Under the changing health economy, new players are stepping into the ring, including retailers, tech companies, airlines, and hotels that are providing basic health-care services, incentives, and benefits for consumers outside the traditional health-care model. All around the world, millions of people are downloading health apps, using their phones, mobile devices, and computers to access medical information, consultation, and even diagnosis and treatment.