When it comes to receiving proper healthcare, the most important thing is the patient. Pharmaceutical and healthcare compliance is crucial to patient safety. Defined policies and procedures are necessary when dealing with the health, safety, legal and regulatory requirements in the healthcare industry.
Healthcare is strictly regulated in the United States compared to other countries. “The array of regulations that govern healthcare can seem overwhelming to people who work in the industry. Almost every aspect of the field is overseen by one regulatory body or another, and sometimes by several,” wrote Robert I. Field, JD, MPH, PhD on the complexities of healthcare regulation. In this article, he discusses that the harsh ruling boils down to what’s at stake if these rules aren’t set in place. When the concern centers around the life of a human being, it makes sense. It’s not so much that the rules exist, but the way in which they exist that complicates things. He says that, “health care regulations are developed and enforced by all levels of government—federal, state, and local—and also by a large assortment of private organizations. At times, they operate without coordination.”
Because of the many regulations that companies in the pharmaceutical and healthcare industry must follow, it’s crucial for these companies to deploy a system that enables them to effectively manage their products & services. Gensuite offers a full suite of software solutions related to this industry. Working with customers such as Sage, Lilly, Johnson & Johnson and Medtronic, Gensuite can cater to each individual company’s need.
Some of Gensuite’s solutions and related applications include:
Audit & Compliance Assurance
Gensuite’s Audit & Compliance Assurance solution suite enables companies to engage sites, businesses and corporate teams in tiered regulatory compliance audits and program assessments. With Gensuite’s audits tools, teams can:
- Audit regulatory compliance risk using internally developed or licensed auditing protocols
- Enable scheduling of audits, manage auditors, and audit risk execution
- Develop custom inspection checklists to meet inspection program requirements, assign responsibility and track completion
- Use environmental management software to track compliance and operational tasks; setup automatic reminders and custom escalations
- Leverage mobile for audits in-the-field, regardless of connectivity, including photo and video capture capabilities
The Chemical Management applications that Gensuite has developed helps companies in the pharmaceutical and healthcare industry manage hazard communications more effectively.
- Meet hazard communication (HazCom) obligations through easy to use desktop and Mobile-friendly search capability
- Maintain up-to-date SDS software for all chemical products
- Generate Globally Harmonized System (GHS), National Fire Protection Association (NFPA), and Health Information Management System (HIMS) compliant labels for container marking and shipping needs
- Setup a customized workflow for review and approval of all new chemical products
- Screen country-level regulatory applicability for chemical products and ensure compliance with reporting requirements
- Manage chemical inventory tracking from order entry to onsite usage with inventory management extension features
These are just two solution suites that Gensuite offers to companies to help manage audit and compliance assurance and chemical inventory within a single system. Gensuite offers an array of comprehensive software tools that span environment, health, safety, sustainability, security, product stewardship, responsible sourcing and asset management and can be customized to meet business-specific needs.
Gensuite keeps pharmaceutical and healthcare companies protected in a rapidly-changing world and gives businesses a competitive edge in this strictly regulated market. To learn more about benefits and features of Gensuite’s pharmaceutical and healthcare compliance and management solutions, click here.