Facing Compliance Issues With Operational Efficiencies
To meet regulations from the FDA and others, pharmaceutical and biotech companies must be able to manage data to show evidence of compliance while accelerating time to market. Companies face increasing frequency and duration of audits, regulatory warnings, and consent decrees. Though regulations keep changing, the last few years of transformation in the pharma/bio industry haven’t minimized the continuous pressures on pharma/bio organizations to innovate and grow. Companies are addressing these pressures with familiar tools and strategies namely M&As, expansion through biologics, outsourcing and advanced technology/digital capabilities. What has changed, however, is the way in which organizations are leveraging these tools across the enterprise and outside the traditional four walls.
Ever-growing margin pressures and increased financial scrutiny are forcing manufacturers to innovate and re-conceptualize even the most elemental business functions, requiring new technologies and business partnerships. As manufacturers prepare to meet regulatory requirements around serialization, (2017 Drug Supply Chain Security Act) key components for enterprise visibility will require systems/data integration and more collaboration. End-to-end quality management throughout the product value chain is now a necessity to increase the speed to market, and to protect both companies and patient safety while meeting increasingly complex regulatory demands.
Efficient, Cost-effective Enterprise Quality Management System designed to meet Pharmaceutical and Biotech Requirements for Visibility, Control, and Collaboration
“Building in” compliance can be accomplished in many ways including business capabilities and technology enablers. The ComplianceQuest solution facilitates enterprise-wide transparency and collaboration in managing quality initiatives and compliance processes. It enhances information management and provides unprecedented data visibility into every aspect of compliance through your product value chain.
The ComplianceQuest differentiation is the integration of these quality and compliance processes and data, which delivers incremental value and increases operational excellence while driving continuous improvement and growth. Immediate access to accurate reporting and analytics enables the identification of trends and patterns from all levels of the organization enabling faster and more predictable results. This insight is a strategic enterprise advantage, one that affords a proactive approach to counter any quality or compliance risk.
Seamless Integrated Platform with Compliance Built-in
ComplianceQuest recognizes that the critical processes needed to sustain compliance require insight into regulatory requirements, knowledge of industry best practices, and a clear understanding of any process deficiencies. ComplianceQuest’s integrated 100% cloud QHSE solution helps reduce the time and cost to manage documents, identify and resolve problems in product development and introduction, manage supplier quality, and help ensure a trained workforce. Built-in best practices include validated controls, audit trails, e-signatures, permissions and security structures. Simultaneously gaining control of these areas will result in a sustainable compliance strategy.
ComplianceQuest also interfaces with a company’s internal systems including ERP, MES, LIMS, HR, and PLM to ensure that compliance and quality are part of the entire product lifecycle management. Automating workflows and escalations based upon established best practices relies heavily on interoperability between disparate systems. This is because each of the disparate technologies captures quality data important to the overall enterprise. By providing complete end-to-end quality visibility, pharma/bio organizations can quickly and easily verify compliance from design to delivery. The result is streamlined decision making, reduction in the cost of bringing new products to market and the elimination of numerous warning letters and recalls.
- 21 CFR Part 210/211, 600
- EU Directive 2003/94/EC, EU Annex 13
- cGMP, cGxP
- ICH Q8, Q9, Q10, Q11
- FDA 21 CFR Part 11, EU Annex 11
- ISO 9001:2015
- ISO 14001
- ISO 18001/45001
- ISO 31000