Simplify, simplify, simplify—Thoreau said this in regard to removing complexity from our daily lives. At Sparta, we say this can apply to quality management as well.
In a previous article, we talked about the challenges to effective quality management, including use of siloed or homegrown systems. But quality doesn’t have to be hard—in fact it shouldn’t be. With solutions pre-packaged to fit the needs of regulated industries, it isn’t.
A good quality management solution is intuitive, simple to use and encourages user adoption. This is the basis of Sparta’s Quality Process Accelerators (QPA), which can help streamline and speed up your path to quality.
Backed by Industry Experience and Influence
Your organization can simplify and standardize your quality management processes with Sparta’s QPAs. Sparta’s intelligent, pre-validated quality processes are built on almost three decades of industry best practices. Our leading processes are backed by decades of feedback from customers and regulators—in short, we know the industry and the quality drivers your organization needs to be successful.
- Related article: FDA raising quality technology expectations
Plug and Play: Achieve Rapid Time to Value
With Sparta’s QPAs, you can get your system up and running quickly, resulting in rapid time to value. This process standardization and simplification drives significant value and time savings for the end user.
Simplicity in a Digital Quality Solution
Our QPAs, developed in conjunction with Sparta’s Quality Best Practices Council, assure that change is managed at both the site and corporate and global level, with the appropriate personnel involved in change assessment, planning, approval, implementation and deployment.
Sparta’s QPAs include:
- Nonconformances: The nonconformance QPA records data about situations in which a product or device has not conformed to standards. This provides insight into which devices don’t conform, how they go against standards, where they are produced and how customers are impacted. It enables users to identify, record, assess and investigate deviations and nonconformances in a consistent and harmonized process.
- Corrective and Preventive Action (CAPA): Complaints, audits and adverse events often lead to compliance events that must be addressed through a company’s CAPA process. The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.
- Audit Management: The audit management QPA helps companies monitor critical processes, identify gaps and improve quality. This solution drives efficient management of resources, workflow, data and records associated with company internal audits of all levels as well as with audits relevant to suppliers and company regulatory inspections. This process allows manufacturers to take a best practices approach to compliance and risk management.
- Change Control: The change control QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected. It enforces a standardized change control process across the enterprise while allowing the flexibility to meet specific workflow steps, making it the only solution designed to be flexible enough to manage all types of changes using one centralized system.
- Out of Specification: Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA. OOS records contain information on situations when lab results come back out of the range in which they were expected.
- Intake: The intake QPA enables users to capture critical information using a simple, browser-based interface and share it with quality and compliance teams from anywhere, on any device.
- Extension Request: Use the extension request QPA when a time-sensitive record cannot be completed on time. It contains information on the record, the original due date, a suggested new due date and reason for the delay.
- Quality Events: Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues. Quality events contain information on an event that has occurred regarding the quality of a product, as well as the actions that should be taken to minimize the negative impact of the event.
- Batch Release: The batch release records contain information on a grouping of products that are being manufactured together.
- Complaint Handling: Track, triage, escalate and share records in a centralized and validated platform. The complaint handling QPA provides the ability to log, respond to and investigate complaints. It enables monitoring of developing trends through integrated tracking and reporting.
- Risk Management: Risk Management enables companies to seamlessly link the risk process to other quality management processes. It facilitates the implementation and maintenance of a risk management program in accordance with ICH Q9 and ISO 14971.
- Supplier Quality Management: Effectively manage and collaborate with suppliers and contract manufacturers across your supply chain. Supplier quality management allows quality teams to manage supplier relationships from onboarding to auditing and scorecard analytics.
- Product Registration Tracking: Product Registration Tracking (PRT) significantly reduces the time, cost and resources needed to track product submissions with regulatory agencies around the globe.
Sparta’s QPAs help simplify the process of quality management and drive success for regulated industries. Start improving productivity and reduce the chance of errors by enabling quality teams with the best practice processes, automation and collaboration that a digital quality management solution provides.
Interested in learning more? Request a demo and see firsthand how Sparta’s QPAs can benefit you.