PERFEQTA Pharma Compliance Software
PERFEQTA helps pharmaceutical companies across the spectrum with reporting and control mandates regardless of type or size. We optimize Pharma compliance for risk management, to reduce costs, enhance patient safety and improve quality and clinical operations. Let us show you how we eradicate paper, worksheets, and outdated software. Our practical implementation is simple for drug development, clinical trials regulatory affairs, and puts you in charge.
A dream Quality Management System (QMS) for Pharmaceutical Organizations
Move freely knowing your software moves with you
Regulatory Compliance Software
PERFEQTA is compliant with HIPAA, FDA 21CFR Part 11 and Part 820, ISO, CLIA, GAMP5 and GxP, US FDA, current Good Manufacturing Practice (cGMP), ISO 9001:2015, and other regulatory requirements and standards concerned
Real-time Quality Control Monitoring
Receive instant updates of quality control events across equipment, personnel and procedures to exceed operational control requirements
CAPA and SCAR Integration
Automate CAPA and SCAR pharmaceutical industry 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 quality management system modules without an internet connection to work from anywhere
Keep your highest priority workflow items at the top of your personalized dashboard for industry regulatory concerns
Instantly know if quality assurance procedures are not followed or have been modified to align corporate compliance activities
Delete every paper form from your supply chain and replace it with automated software apps for corrective and preventive actions
Network Security Integration
Easily integrate with your existing enterprise network security solution
Regulatory Compliance in the Pharmaceutical Industry
Regulatory compliance for healthcare products companies means being in accordance with the regulations set out by regulators. A pharmaceutical quality management system like PERFEQTA is used to meet industry based regulatory compliance. These regulations are made by the regulatory agencies across the US, whose intention is to ensure the quality of work is in accordance with multiple regulatory regimes.
Meeting regulatory compliance requirements for the industry regulatory establishment is important for businesses in all sectors, but is of critical importance to pharmaceutical, medical devices and healthcare because of the reasons stated below. By complying with regulations set out by pregulatory bodies; an organization in the pharmaceutical industry gains the following benefits:
A major benefit of PERFEQTA with regulatory requirements is that organizations in the pharmaceutical can identify, mitigate and eliminate risk at all stages. A pharmaceutical quality management system monitors risk elimination for regulatory scrutiny, and is built into all quality processes. Regulatory agencies spell out clear pharmaceutical guidelines on how to identify and mitigate risk.
Enhances Customer Focus and Confidence
No product is likely to gain the trust from everyone in the pharma industry right from the customers and employees unless it has met regulatory compliance requirements. A compliance software like PERFEQTA that meets regulatory requirements is the surest guarantee for the efficiency and efficacy of a product. When a pharmaceutical company meets quality management consistently, customers and regulatory bodies with all control mandates set, confidence is met.
Another benefit of PERFEQTA’s pharmaceutical quality management system for companies in the pharmaceutical industry is that it helps to save costs throughout the lifecycle of the product. High costs are associated with ensuring compliance, but the cost of noncompliance and significant financial judgments is higher. If an organization discovers that it has failed to meet regulatory requirements at any particular stage, regulatory bodies will be alerted.
Products that fail regulatory requirements cannot pass the test of regulatory approval. If they have to fulfill the penalty requirements of the FDA or other regulatory agencies time and money is wasted. Meeting regulatory compliance requirements at every stage is the safest and most economical option for a company in the pharma industry.
FDA audits are common in the Pharma industry. Companies that don’t maintain accurate records struggle when an unplanned inspection occurs. FDA inspections are needed to ensure that companies adhere to all product quality and compliance requirements. No organization should struggle to find the necessary details to justify deviations, out of spec procedures, batch approvals, and so forth.
Why Pharmaceutical Companies Fail FDA Audits
An FDA audit gives Pharma companies a perspective on how well prepared they are. Pre-audit preparations are all about PERFEQTA’s compliance software for risk management, supply chain, product quality and manufacturing operations. However, FDA audits can be stressful for the Product Quality Management Officers, Quality Risk Managers for ensuring GMP throughout the process control.
There are a series of factors that contribute to audit failures in major pharmaceutical companies.
- Drug Safety
- Labeling Errors
- Inaccurate Record Keeping
- Vendor Management
- CAPA Failures
- Procedural Deficits
- Equipment Issues
- Complaint Handling
- Training Gaps
- QC Procedures
Easily transform your business processes with our vetted software experts
Work with the pharmaceutical quality management system Software-as-a-Service experts since 2005
Ensure your organization goals are met and your flow issues are resolved
Choose from flexible deployment options and custom timing for you quality control unit
Solve all of your organizations requirements with one comprehensive solution
Use pre-built solutions or easily build your own according to your schedule and budget for data integrity
Receive unwavering support from software experts if you have questions about your workflow
PERFEQTA is so much more than a quality management system! Bring all your work into one platform. Replace your paper forms and hard-to-manage software with one solution across multiple departments without compromise and stay in full compliance. View a sample of our most used solutions here.
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!