Medical device manufacturers must comply with a wide range of regulations like 21 CFR Part 820, as well as medical device reporting, premarket notification 510-(k), investigational device exemption and quality system (QS) regulations. Manufactures are looking to improve quality, reduce costs and identify operational and compliance risks when managing the full audit lifecycle and ensure that findings are resolved in a timely and effective manner.
TrackWise Audit Management Software for Medical Devices
TrackWise Audit Management software solution assists auditors to plan and execute audits more efficiently by providing an integrated tracking system and a powerful workflow engine that automates all steps in the audit lifecycle, including scheduling, preparation, auditing, report approval, report issuance, response and corrective action (CAPA) tracking. Sparta’s audit management software allows manufacturers to take a best practices approach to compliance and risk management and support all audit programs using an enterprise system and can be utilized to manage the responses of audits conducted at a facility, such as regulatory or customer audits, to ensure audit findings are resolved in a timely fashion.
Stratas Audit Management Solution
Stratas for audit management is a cloud-based solution that allows you to include your entire supply chain in your quality system, and integrate supplier management, collaboration, and a fully featured audit solution to drive greater efficiency, lower risk, and raise compliance.Supplier audit management through Stratas ensures all supplier observations and findings are addressed by tracking and managing all audit follow-up, the subsequent investigations, and any resulting CAPA directly with your suppliers.
Benefits of Audit Management Software:
- Reduces risk and increase audit efficiency and visibility by enforcing consistent and harmonized processes and procedures across the organization
- Securely manages all information in a centralized, scalable and reliable closed-loop CAPA system
- Facilitates compliance with industry regulations including 21 CFR Part 11, 21 CFR Part 803 and 21 CFR Part 820; ISO 9001, 13485, 13488, 14001, 14791; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards
- Reduces risk of lost or incomplete data through a centralized, scalable auditing system
- Provides flexible, yet controlled functionality to allow the co-location of multiple diverse auditing groups and processes
- Increases operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities
- Increases accountability through assignments, process step sign-offs, and automated audit trails
- Feeds information to supplier oversight processes to enable truly integrated supplier oversight
Sparta Systems Audit Execution Package
Sparta Systems Audit Execution Package is an additional offering that can be utilized to generate even higher levels of efficiency and consistency in audit programs. This package changes the audit paradigm by enabling auditors to document results in real time and eliminating the error-prone and time-consuming copy/paste steps found in most audit programs. This offline tool gives auditors the ability to conduct the audit and document results, including any associated observations, whether signed into Sparta’s solution or not. The Audit Execution Package bridges the gap between the needs of the executive team and auditors, providing management the consistent data needed to evaluate audit program effectiveness while providing auditors the flexibility and authoring tools they need to be successful in the field.
- Saves time and ensure consistency by creating audit templates with as little or as much flexibility as standards and corporate policy dictate
- Improves auditor efficiency by enabling them to document results and create offline observations which then automatically create the records in Sparta’s solution when imported back into the system
- Improves supply chain collaboration to audit observations by enabling suppliers to respond electronically, in the format preferred
Click here to read more on our Audit Execution Package