Good Laboratory Practice (GLP) for GxP operations regulates the processes and conditions under which clinical and non-clinical research is conducted. GLP also governs how these research facilities should be maintained, preserving their identities while ensuring compliance with international guidelines that are dictated by ICH – The International Conference on Harmonization (ICH). One such set of regulations pertaining to good lab practices can be found within GCP or “Good Clinical Practices.” These rules ensure ethical conduct during all stages including study design methodologies data reporting; thus preventing any unethical practices from occurring. software for gxp operations
GMPs regulate one’s manufacturing process ensuring identity strength purity drug product etcThe Food and Drug Administration (FDA) has the right to inspect studies that are the basis for products marketed in the United States, regardless of where the products were developed or manufactured.
Good Clinical Practice Regulations
GCP is an important part of ensuring the safety and success for trial participants. It’s essential that there be systems in place to report all AE or SAE, as well as data collection during clinical trials which meets GACC regulations so it can remain trustworthy when being used later on by sponsors/investigators who must ensure compliance with these standards before beginning their own study procedures throughout every stage including inspections from FDA-approved bioresearch monitoring programs like BIMO.
It also governs how often studies are monitored themselves through inspection processes where inspectors check up periodically at different points within projects ranging form preclinical tests right down into finishing touches.
Good Manufacturing Practice Regulations
Global Manufacturing standards, or GMP for short can be defined as a set of requirements that all manufactured goods must meet in order to avoid being considered “defective”. The main focus when creating these regulations was on quality control and safety which led them into existence. One responsibility during an inspection under this law would include ensuring compliance with certain procedures like using good materials only if applicable; identifying any deviations from standard product specifications through rigorous testing (including third party inspections); conducting inspections at appropriate times before release onto markets so no mistakes go unnoticed post-production for medical devices or drug products.
GLP, GCP and GMP regulations is a regulatory framework that ensures the highest possible standards in scientific research as well as ethical practices. The three sets of guidelines protect consumers from study protocols which may not be up-to date or accurate; patients who could potentially become participants for trials without full knowledge about all risks involved (including potential side effects); test subjects during experiments themselves by ensuring their safety throughout this process under regulated industries’ international quality assurance measures – aimed at protecting both parties equally Researchers expect high standards with the appropriate quality control and quality assurance measures in place. All three sets of regulations protect consumers, patients, test subjects, and researchers.
Simply your GxP operations while saving money and time with PERFEQTA
- Bring your data collection, processing and analysis into one platform into solutions built around your standard operating procedures across all sites and mobile apps
- Effortlessly ensure that your GxP operations are producing safe and fit medical devices for use to meet strict quality standards
- Be audit-ready across your entire gap operations without unnecessary expenses, man-hours, or time spent on inefficient processes
- Track the entire operation from start to finish in a single dashboard with mobile apps
- Turn findings into actions and actions into positive outcomes
- Deploy changes across your organization or to specific departments quickly
- Nurture a quality-first culture for GxP operations
Nurture a quality-first culture for GxP operations
- Be ready for audits at any time
- Configure your SOPs using flexible workflow rules
- Know in real-time the status of each medical device operation
- Aggregate content design results quickly to share with staff
- Receive alerts if an audit is not complete
- Organize recent version or last version findings by severity
- Use one of PERFEQTA’s 30+ reporting charts or tables for content design
PERFEQTA’s quality control software works with clinical, medical, analytical, and quality laboratories for FDA compliance to help them optimize their operations, reduce turn-around times, reduce costs, reduce risk, and improve quality and compliance.
PERFEQTA is so much more than a laboratory information system! Bring all your work into one data management platform. Replace your paper forms and hard-to-manage software with one solution across multiple departments without compromise and stay in full compliance.
Just a few GxP apps available
PERFEQTA helps highly-regulated organizations effortlessly meet the FDA’s GMP, GDP, GLP, and GCP guidelines. Extend your enterprise systems, reduce your costs, and grow your GxP operation.
Quality is key to any organization’s operations. Improving control and disability into aspects of your operation can raise the quality level and help your organization perform at top-tier levels like never before.
PERFEQTA works with clinical, medical, analytical, and quality laboratories to help them optimize their operations, reduce turn-around times, reduce costs, reduce risks, and improve quality and compliance.
Move freely knowing your software moves with you
PERFEQTA is compliant with HIPAA, FDA 21CFR Part 11 and Part 820, ISO, CLIA, GAMP5 and GxP.
Real-time QC Monitoring
Receive instant updates of quality control events across equipment, personnel and procedures.
CAPA and SCAR Integration
Automate CAPA and SCAR processes to save exponential amounts of time.
Integrate with over 1500 software tools and systems, including BECS, ERP, MRP, LIS, and CRM.
Offline Data Capture
Add data to PERFEQTA modules without an internet connection to work from anywhere.
Keep your highest priority workflow items at the top of your personalized dashboard.
Instantly know if quality assurance procedures are not followed or have been modified.
Delete every paper form you use daily and replace it with automated software apps.
Network Security Integration
Easily integrate with your existing enterprise network security solution.
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.”
PERFEQTA’s pricing is simple, always ROI-positive, and easy to budget. We will build a customized pricing plan that fits the needs of your organization and you won’t pay for features you won’t use. When you contact us, we’ll reach out on a discovery call to gather the necessary information about your organization’s goals and provide you with a pricing statement on the first call.
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!