Life sciences and pharmaceutical companies have a commitment to ensuring that their products are safe for humans to use. They often conduct audits to confirm that their processes, raw materials, training and documentation, third-party suppliers, and outsourced manufacturing operations are all compliant with current good manufacturing practices (cGMP). These audits also help ensure that they are prepared for inspections by regulating bodies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada, and others. This helps companies avoid findings, letters, legal issues, and significant revenue loss. Simple mistakes can delay drug approvals, halt drug production, and negatively impact a company’s reputation—and stock price. Even with preparation, companies can find themselves non-compliant; in 2020, pharma companies received nearly 3,000 observations for 350 different categories of non-compliance from the FDA alone. These included: Lack of written procedures or failure to follow written procedures Failures in laboratory controls Faulty production record reviews Absence of written procedures Improper cleaning/sanitizing/maintenance Whether an inspection of manufacturing sites and processes is self-scheduled, or it is a “surprise visit” from a regulator, the process of proving compliance can be stressful and time-consuming—especially for companies that don’t meticulously maintain accurate and complete records. However, even companies that have robust documentation processes in place can struggle to present the right records if their information is spread across different systems (like QMS, MES, CMMS, or EAM systems) that don’t connect to one another. These disparate sources of information make it difficult to reconcile and explain deviations, batch approvals, and change requests to regulators, while also creating tedious work for quality teams as they dig for the right paperwork. Plus, because health authorities are moving toward risk-based audits and inspections, companies that have issues will be audited more frequently and more deeply. When a regulatory body inspects a company, they look to the quality team to provide a single source of truth; they want to see how issues are tracked, what the quality process is, and how a CAPA is identified, initiated, and eventually resolved. There are many people, processes, and documents involved in an audit or inspection. Nuvolo simplifies a significant piece of the documentation process to save you time and stress. How Nuvolo Can Help Nuvolo Connected Workplace was purpose-built for life sciences companies, meeting both GxP and 21 CFR Part 11 requirements. Plus, it’s validated for IQ/OQ/PQ*. All equipment and asset records are saved on one platform, allowing users to see and pull any activity associated with an audit request, including onboarding, maintenance and calibration, usage, and retirement. Because it has an open API, it can send information directly to your QMS, streamlining quality processes that involve equipment. This is made possible through a number of features, including: Flexible enforcement of versioning controls based on GxP relevance and risk factors Configurable workflows that allow groups or individuals to be aligned to the desired approval process Exportable audit trails that are permanently associated with your controlled records Electronic signatures that meet 21 CFR Part 11 requirements Automated preventive and corrective maintenance assignments Technician skills and competency tracking Product recall and safety alert management support Standard or custom risk inclusion frameworks Are you ready to better support your quality processes? Learn more about how Nuvolo Connected Workplace for Life Sciences helps companies automate compliance and ensure data integrity. *PQ will be available in our Connected Workplace for SMB product in Q2 2022. Share
