Companies in the pharmaceutical industry must maintain some of the strictest compliance regulations because of the need to safeguard the health of patients. These compliance regulations govern every aspect of the development, production, and delivery of pharmaceuticals.
IT compliance has become critical in the pharmaceutical industry as companies come to rely on technology or pharma tech, such as AI and machine learning (ML) for drug discovery and IoT for manufacturing and distribution. As pharma companies turn to technology and digital processes, data plays an increasingly important role in researching, prescribing, and tracking the distribution of pharmaceuticals.
The data related to managing and understanding the lifecycle of pharmaceuticals must be kept secure, meaning that maintaining IT compliance is vital for ensuring that safe and effective products reach consumers.
The pharmaceutical industry relies on distributors to transport drugs from manufacturers to pharmacies and patients. Supply chain security compliance is crucial for ensuring that patients are receiving safe and legitimate products. Systems need to be in place to track the warehousing and transport of pharmaceuticals to keep them from being tampered with and to prevent illicit drugs from entering the supply chain.
In 2023, all pharmaceutical distributors were required to comply with the Drug Supply Chain Security Act (DSCA) to protect the public from harmful drugs. Under DSCA, regulatory bodies conduct inspections of distributors to determine that they are meeting compliance requirements for identifying and tracing prescription drugs. Data repositories and warehouse management systems (WMSs) should enforce compliance by tracking events in real time to maintain a seamless record of the chain of custody for pharmaceuticals. Distributors that fail to comply face audits, penalties, and loss of customer trust.
Sensitive data plays an important role in many aspects of the pharmaceutical industry. Data in patients’ health records determines which pharmaceuticals they will be prescribed. Data is used in safety and clinical trials to decide which drugs are safe and effective enough to be put on the market. During the manufacturing process, data helps pharmaceutical companies produce a quality product.
For these reasons, maintaining data integrity is a key part of IT compliance in the pharmaceutical industry. Through its 21 Code of Federal Regulations (CFRs), the FDA defines data integrity as the completeness, consistency, and accuracy of data across the lifecycle. Pharmaceutical companies are required to preserve the original form of data, prevent unauthorized access to sensitive information, and create an auditable trail of any access or use of data.
Pharmaceutical companies must use electronic records and signatures to guarantee the authenticity and traceability of data. Preventing data from being falsified or altered by accident protects the reliability of information that must be used to make healthcare decisions.
Like other types of healthcare organizations, pharmaceutical companies must follow Health Insurance Portability and Accountability Act (HIPAA) compliance regulations. Pharmaceutical companies handle patient medical information, so they are required to allow patients access to their information while preventing unauthorized access.
Pharmaceutical companies need to have processes in place for archiving patient data and keeping auditable records of access attempts. Data protection and security measures must be enlisted to prevent data breaches that would allow patient data to be stolen, compromised, or sold on the black market. Access to medical data should be tracked and controlled to protect patient privacy, ensure that medical decisions are made based on correct and complete information, and prevent fraud.
Maintaining compliance in the pharmaceutical industry requires that companies have the correct tools and processes in place to secure data and produce auditable records. Meeting compliance takes a lot of time and effort and draws on knowledge of industry-specific regulations. To reduce the risk of failing to meet compliance, pharmaceutical companies should partner with a technology company that has expertise in compliance.
As part of XceptionalProtect, we provide Compliance-as-a-Service and virtual CISO (vCISO), two offerings that relieve pharmaceutical companies of the burden of managing tasks associated with meeting HIPAA compliance by setting policies and procedures to address the unique compliance needs of the pharmaceutical industry.
Is your pharmaceutical company struggling to keep up with the demands of IT compliance? Request a cybersecurity assessment and proposal from the compliance experts at Xceptional.