Quality and process management software for highly regulated environments
PERFEQTA was initially conceived and developed to address and help keep compliant the life science industry’s complex and high regulated operational requirements. When lives depend on sterile work environments, precise record keeping, efficiency, strict compliance with mandatory regulations and adherence to standard operating procedures , PERFEQTA delivers with an agile platform to automate any process. Working with organizations such as The University of Texas – MD Anderson Cancer Center, PERFEQTA has been engineered to allow for effortless data collection, analysis, and reporting all within a single application.
Today, the blood donation and transfusion department within MD Anderson is utilizing PERFEQTA to manage equipment calibration, scheduled maintenance and quality control events. Additionally the software platform is responsible for the monitoring of quality on reagents as well as capturing data related to SOP adherence and delivering reports crucial to the lab operations. Further, PERFEQTA can be configured to be fully compliant with standards set forth by CLIA and CAP as well as regulatory agencies such as the FDA and AABB. The commitment to the blood center doesn’t end with MD Anderson, PERFEQTA for Blood Centers, the newest template version of the software is set for release later this year and comes with optional modules for equipment management/QC, donor services, human resources, and quality management system related processes as well as an optional document management system.
Aimed at increasing productivity through the optimization of quality and process management strategies, PERFEQTA provides a premium web-based platform for introducing and tracking continuous improvement initiatives. Complete with a full audit trail and features such as an eSignature add-on that meet 21 CFR Part 11 for electronic records, PERFEQTA allows users to create eForms, workflows, and more all in a controlled software environment. PERFEQTA is hosted and maintained on the highly secure cloud platform provided by Amazon Web Services and both Amazon and Productive Technologies, the software manufacturer behind PERFEQTA maintain interpretation and compliance statements for 21 CFR Part 11 as well as a multi-level Disaster Recovery Plan (DRP) to help healthcare and life science organizations of all sizes focus on their primary mission of saving lives.
As varied as healthcare and life sciences processes and quality control standards can be, PERFEQTA is scalable and adaptable. Completely configurable with Out-of-the-box functionality means implementation and validation are easy, plus there is no additional cost to customize forms, applications, and reports. Additionally, PERFEQTA’s full audit trail ensures that the system remains compliant to regulatory mandates while the ability to duplicate validated questions, procedures, and apps dramatically reduces the amount of time required to launch eForms for data collection tasks. With PERFEQTA maintaining compliant healthcare and life science operations has never been more dynamic and adaptable. Designed with regulatory compliance as one of the highest priorities, it’s no wonder why we say “Quality is in PERFEQTA’s DNA!”
FDA & HIPAA Compliant SoftwareWith a complete audit trail, 21 CFR Part 11 compliant eSignature, and an extensive roles and permissions administrative design function, PERFEQTA can be configured to meet the strictest regulatory compliance. PERFEQTA is also available with a fully integrated document management system and can be accessed securely as a fully hosted, hybrid, or on-premise solution.
Healthcare & Life Science Quality Management SystemPERFEQTA’s developers have worked with ISO:15189 medical laboratories as well as ISO:17025 testing and calibration facilities to design workflows, eForms, reports, and more that help manage quality to the highest standards. Document-centric processes relating to SOPs, training, and compliance can be configured to meet 21 CFR Part 11 for electronic records with eSignature and document version control.
Medical Practice & cGMP Operations ManagementConfidently manage business processes related to operation of a medical practice, research organization, or cGMP manufacturer in a fully auditable and traceable platform. Identify key areas for continual improvement initiatives and seamlessly introduce fully validated procedural strategies without slowing down the business. PERFEQTA is designed to capture data, drive workflows, and manage complex conditional processes effortlessly through “smart alerts,” schedules, and email/SMS notifications.
Medidata estimates data collection to take 3 months with revisions in a paper-based system.
Electronic Data Capture (EDC) with compatible software like Perfeqta collects the same data in 3 minutes.