How Life Sciences Firms Can Improve Regulatory Compliance
By
Life Sciences Review | Tuesday, February 09, 2021
To properly manage regulatory compliance, life sciences organizations must present accurate and up to date documentation, assessment preparedness, and competitive intelligence.
FREMONT, CA: Pharmaceutical and life sciences organizations must prepare for and manage a new surge of regulatory review and enforcement actions. Failing to comply with changing regulations can bring serious consequences, including hefty fines, criminal prosecution, and debarments. Attaining regulatory compliance is mandatory, not optional. Suppose all the resources must consistently adhere to predefined processes. In that case, authorities want firms to relook the current way of documenting IT processes and training to reduce the chance of deviation and increase the likelihood of regulatory compliance.
A recent study identified five levels of maturity for compliance integration within life science organizations. It is reactive, defensive, passive, or superficial compliance, operational, or transactional compliance, strategic, or embedded compliance, and holistic, or fully integrated compliance. These five stages of compliance illustrate the considerable gap between organizations that realize compliance at the forefront of business decisions and those that fail to consider compliance as a vital part of their product development process.
Regulatory documentation is constantly under audit. So, it is vitally essential to ensure that submissions are compiled based on present regulatory standards. Introducing a digital document and quality management system can help a firm to stay in control of data. Encouraging a culture of quality within the organization is essential to maintaining Continuous Quality Improvement (CQI). The best method to ensure user engagement is to offer a simple, intuitive solution that enables automation and standardization in the processes.
Within validated systems, change process management requires to be held to a high degree of accuracy. And they are making sure that a single source of truth within a secure file structure and shared folder levels is vital. Document changes must be mapped, and external security problems must be addressed proactively rather than reactively. The solution life sciences firms use should be seamlessly configured, maintained, and updated, breaking firms from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or add a step to the process.
