Historically, compliance management has been initiated to respond to meet compliance requirements for a specific regulation. At an organizational level, it is usually achieved through compliance management processes which identify the applicable requirements, assess the state of compliance, assess the risks and potential costs of non-compliance against the projected expenses to achieve compliance, and then prioritize, fund and initiate any corrective actions deemed necessary.
As more stringent regulations continue to impact and dictate quality management decisions in industries such as pharmaceuticals, medical device, and consumer products it is becoming increasingly important to produce products within the confines of very particular compliance requirements – and in order to manage and control these increasingly complex compliance risks, more organizations are turning to technology for help.
Sparta Systems’ Compliance Management Solution
A compliance management solution provides a common framework and an integrated approach to manage all compliance requirements faced by organizations today. The implementation of compliance management system as an integral piece of an overall quality management system is a hub for cross-functional communication and collaboration to manage compliance and control initiatives across the entire organization. This compliance system centralizes, streamlines, and standardizes quality process data and content from across the value chain, providing those responsible for making decisions with a holistic perspective that would otherwise be quite difficult to obtain.
Why Implement a Compliance Management Solution?
Organizations that use Sparta Systems’ compliance management solution to manage compliance risks often experience additional efficiencies and compliance cost savings such as:
Business Process Automation and Synchronization: Automates traditionally manual and paper-based compliance management processes that are common across many industries such as such as corrective and preventive action (CAPA), audit management, and risk management.
Interaction with Suppliers: Sparta Systems’ quality management solution along with the Stratas Supplier Collaboration Portal, a cloud solution from Sparta Systems, opens up the lines of communication with suppliers providing more visibility and control into the supply chain. This line of communication can be used to prevent adverse events, protect brand reputation, reduce compliance risks, reduce compliance costs, and therefore improve long-term profitability.
Closed-Loop Quality Processes: The closer a product issue is identified to the customer, the more costly it is to an organization. By integrating traditionally standalone compliance management systems, Sparta Systems delivers a closed-loop quality environment for sharing quality process data and content.
Visibility into Key Performance Indicators: As companies contend with increased regulation, competition and globalization, the ability to leverage and analyze quality-related data to gain insight across the enterprise is critical. TrackWise QualityView provides the data necessary to foster strategic development, formulate plans, and optimize business operations in a self-service model that enables greater data availability while eliminating the dependence on IT.
Benefits of Sparta Systems’ Compliance Management Solution:
- Streamline and manage compliance requirements to reduce compliance costs by improving response and closure times
- Implement a global approach to compliance and control with multi-site usage, multilingual capabilities, regional reporting requirements and unlimited security levels
- Protect brand reputation and increase customer satisfaction by ensuring that compliance risks are investigated and responded to in a timely manner
- Automate the existing compliance management process by assigning compliance initiatives and related investigations based on manufacturing location and product type
- Further develop compliance management strategies for the management of the compliance lifecycle with real-time trending and escalation of potential safety issues