PERFEQTA helps highly regulated organizations comply with FDA regulations by documenting actions across different activities, and managing their quality system effortlessly.
PERFEQTA was built from the ground up on a compliance-rich framework with specialized features to help comply with FDA 21 CFR Part 11 Section 11.10, Part 11 Section 11.10, Part 11 Section 11.10a, Part 11 Section 11.10i, Part 11 Section 11.10k, Part 11 Section 11.50a, and Part 11 Section 11.70. Assure compliance with electronic signatures that ensure the authenticity of electronic records, and the ability to validate them. This provides a solution to verify that approved users have been trained to perform tasks, and gives you the ability to track revisions and versions with a detailed audit trail for each record and activity performed in PERFEQTA.
PERFEQTA helps organizations following FDA regulations FDA 21 CFR Part 11 Section 11.10, Part 11 Section 11.10, Part 11 Section 11.10a, Part 11 Section 11.10i, Part 11 Section 11 with their compliance, quality management, and the performance of quality control and other operational activities.
With PERFEQTA, users in GMP, GLP, GCP, GDP, and other Good Practice type organizations can use one or multiple solutions that are part of the PERFEQTA platform, or we can configure one for them to fit their exact requirements, fast.
Along with electronic signatures, per FDA Title 21 CFR Part 11, and all of its sub-parts, GxP organizations use PERFEQTA to handle their processes. From document control, CAPA, equipment management, maintenance and calibration, in-process quality control, and hundreds of apps and dashboards, PERFEQTA helps GxP operations control their process better and meet quality standards with ease.
PERFEQTA HIPAA is the HIPAA-compliant version of PERFEQTA, where Protected Health Information (PHI) is stored and processed by customers, according to the United States Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Please inquire about the HIPAA option and about executing a Business Associate Agreement and how it can best serve your needs.
PERFEQTA helps organizations efficiently meet ISO 9000, ISO 9001, ISO 13485, ISO 14000, ISO 14971, ISO 15189, and ISO 17025 standards across different industries.
PERFEQTA makes complying with ISO standards effortless. Solutions for document control, Corrective Action Preventive Action (CAPA), nonconformance, supplier qualification, risk management, deviations management, training management, competency assessment, facilities management, contract management, enterprise-level reporting, and an intelligence suite to increase visibility into your operation are found in the PERFEQTA platform.
PERFEQTA has specialized features that make recording data, managing workflows, and assuring quality easy to implement, so you can spend your time growing your organization.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing.
PERFEQTA helps make compliance easier for our laboratory customers with a more straightforward way to document actions and a streamlined application to follow Good Laboratory Practices (GLP). Using a robust list of QMS solutions (CAPA, deviations management, document management, risk management and, change control) and a training module, CLIA compliance is effortless.
Clients also use PERFEQTA to perform multiple types of quality control for assets and analytes. PERFEQTA has proficiency testing solutions to streamline the process of receiving and sending survey test results as well.
Industries we strive to impact
Top names trust PERFEQTA
“After using the PERFEQTA platform, MD Anderson users reported that PERFEQTA made a great impact on their daily operations. They praised PERFEQTA’s intuitive design, flexibility, ease of use and the support from the PERFEQTA team. The platform scored exceptional marks in regard to reliability and the implementation process.”
“PERFEQTA has removed manual paper records and captured required documentation electronically for our blood bank, ensuring compliance with FDA, AABB, CAP and ISO standards. PERFEQTA is responsive to our needs, enabling us to customize Reagent and Blood QC apps quickly, ultimately supporting quality care for our patients.”
“PERFEQTA is the perfect solution for a regional blood center because it grows with you. We can automate our daily quality control processes, improve efficiency and reduce costs. Hoxworth expects to save 4x our investment in spending in our first year on the platform. Transitioning our team from paper to PERFEQTA has been transformative.”
The PERFEQTA promise
We're confident PERFEQTA will be faster to implement than buying off-the-shelf software or building your own custom solution. We promise to get you up and running on your own environment in days not weeks or months.
With 99% customer satisfaction, PERFEQTA has grown with the QMS needs of our clients in life science and beyond since 2005. As your needs grow, PERFEQTA grows with you. Schedule a demo for your organization today!