Audit & Compliance
From mandatory government regulations to voluntary industry standards, maintaining and monitoring compliance to operating procedures fundamentally rooted in process control is at the core of PERFEQTA’s development. Launched from the FDA regulated, industry leading portfolio of Sigma Blood Systems’ products, quality is in PERFEQTA’s DNA. Standard with a full audit trail that captures every sign-on, data edit, application version, and more, PERFEQTA provides peace of mind and most importantly, complete compliance to mandated regulations applicable to multiple industries. 21 CFR Part 11 compliant with electronic signature, PERFEQTA provides a secure and fully auditable platform. Furthermore, our team understands the need for multiple software environments for staging or sandboxing, validation, and production, and all of these are included.
Laboratory compliance is just one of the many areas where PERFEQTA’s fully auditable platform can help increase process efficiency. Understanding how users are engaging the system provides critical insight into the work being performed within a business. Even more, being able to pinpoint through reporting where deviation from a standard operating procedure or expected outcome is occurring can be the difference between a company outperforming their competition or falling behind.
Updating industry regulatory guidance, validated and approved operating procedures, and CAPA related events has never been easier. Through the administrative functions of PERFEQTA, you can simply make the changes to the system in one of your non-production environments and implement when and wherever your team is ready. With complete versioning of all of the key components of the system, PERFEQTA makes adjustments simple and clean.
When it comes time to perform internal or external audits of compliance to regulations and process standards, PERFEQTA provides a fully configurable platform to capture data, input responses, compare audit scores and values to previous audits for complete insight into overall performance. With PERFEQTA’s embedded reporting tool, organizational leadership can review results, compare and contrast across locations, implement visual aids such as gauges and drill down charts to identify potential areas for risk.
With customized workflows and multi-level approval configuration, PERFEQTA consolidates audit performance data, responses, training, and acknowledgments to a single platform.