Collaboration is Key to Successful New Technologies
Today, more companies in the regulated sector are embracing new technologies to automate processes, enhance data management, and increase efficiency. Within the pharmaceutical industry, there are a plethora of new tools available (IoT sensors, electronic laboratory notebooks, remote patient monitoring, etc.), and proper implementation requires collaboration across many different departments of the organization. Manufacturing, production, quality assurance and control, research and development, logistics, IT, HR, legal, and regulatory affairs must all be involved in implementing these new digital tools safely. Only working together can they:
Establish a quality management system (QMS) to ensure consistent quality throughout the technology’s life cycle.
Maintain documentation for SOPs, training records, validation reports, and audit trails.
Ensure personnel training in GxP principles and procedures.
Perform qualification and validation of equipment and facilities.
Maintain data integrity.
Follow a well-defined change control process.
Establish a proactive risk management system, with regular internal and external audits.
When investing in new digital tools, success relies on processes and strategies created through cross-functional relationships. Promoting collaboration across departments streamlines workflows, improves collaboration, enhances innovation, and improves resource allocation and communication. Without it, organizations will have misaligned systems that do not meet regulatory requirements, breed chaos, and jeopardize the company’s survival.