What is Quality Control Software?
- It is the degree to which the correct quality management software is produced. Quality control software and quality management software ensures that products are bug or defects free, delivered on time and within budget, meets requirements, expectations, and maintainable. Standard ISO 8402-1986 defines quality as “the totality of characteristics and features of a product or service that bears its ability to implied needs or satisfy stated.”
- In the users view, quality is fitness for purpose or meeting user’s needs.
- In the manufacturing view, quality control means conformance to process standards for quality management, quality control, quality planning, supplier management, risk management, and risk assessment.
How Software Quality Works
Software quality management activities are generally divided up into three core components: quality assurance, quality planning, and quality control.
Benefits of Quality Control Software:
- Increased productivity of the development team.
- Improved Product Quality: Test statistics and defect tracking are more precise and up to date.
- Decreased re-work costs as the detection of defects are found earlier in the software project development lifecycle in every stage.
- Increased confidence levels in existing product management and future product development.
- Increased credibility as the software produced will be highly qualitative.
Quality Control and Quality Management for Today
Quality Control is also part of quality management. However, QC is focused on fulfilling quality requirements. Broadly speaking, it is the inspection aspect of quality management. Quality management is a strategy of detection – it uses operational techniques and procedures to identify defects in products and services and ensure that the project deliverables meet the desired quality standards. The quality control and quality management process detects bugs and defects in the product and reports them so that they can be fixed. If a problem is identified, it must be resolved before the product is delivered to customers. Summing up, quality control is the final checkpoint before the delivery.
Examples of quality control activities: inspection, measurements, manual and automated testing, verification, and validation. These are basic requirements of a flexible quality management system.
Why you should implement PERFEQTA’s Quality Management Software for your Quality Control
Quality Control, similarly to Quality Management, reduces costs. Thanks to QC, customer needs are better satisfied – when you combine QC and quality management activities with requirements engineering processes, you get minimal consumer complaints after the software is delivered. Quality Control reveals common errors so they can be avoided in the future. It develops and promotes quality awareness among employees, which is a great help in attaining the required quality level of the product. Quality Control and quality management increases the competitiveness of the company as it delivers better enterprise quality mangement and meets the requirements of the customer.
Quality Management Software for Compliance in the Pharmaceutical and Biotech Companies
- FDA 21 CFR Part 11
- EU GMP Annex 11
- ISO 9001
- 21 CFR parts 210 & 211
- Quality Management Software for Compliance for Medical Device Companies
- ISO 13485
- FDA 21 CFR Part 820
- ISO 14971
Quality control software customized for your workflow
- Track the entire quality control and quality assurance process from start to finish in a single easy-to-use dashboard
- Receive access to thousands of quality control, quality management, and business apps including document control, patient care-related apps, safety management, training, equipment management, risk management, risk assessment, CAPA and SCAR processes management, JACHO internal audit applications, and analytical reporting, for regulatory compliance all in one place.
- Receive real-time reporting and automatic alerts for quality improvement
- Turn findings into actions and actions into positive outcomes.
- Be a mobile QC manager with just a few clicks from any device
- Nurture a quality-first culture with PERFEQTA
- Easily monitor audit management
Create your own quality processes plan for any quality management process or use one of the available distribution methods such as hypergeometric, binomial, or scan statistics to name a few
- Quickly identify trends and out-of-control quality management processes as soon as they happen and automatically engage second stage plans
- Use Levey-Jennings control charts to detect process changes and ensure process control
- Alert the right people and reduce troubleshooting and response time while maintaining compliance
- Deploy compliance control across your organization or specific departments quickly
- Add more quality management apps as your quality control needs grow
- Record your quality managemnt from anywhere using any device and link it directly to CAPA, SCAR, and deviations apps so you can initiate the proper investigation procedure and improve the quality of product and service you deliver for customer satisfaction.
PERFEQTA for Lab Operations
Easily manage equipment maintenance and calibration while monitoring accuracy, inventory, suppliers, risk management and the entire quality control process with PERFEQTA’s customizable lab operations software modules.
The laboratory needs to be organized around a formal quality management system that supports consistent procedures. The management team and quality unit play an integral role in employee training management along with structures for monitoring ongoing quality for regulatory compliance.
Capable, qualified staff members are the single most important asset to a laboratory. Training, motivation, and engagement are key parts of the quality management system. You also need to document all of your training processes within your quality management system.
Every piece of equipment used in the laboratory must be maintained to operate safely. Also, laboratories need to monitor how equipment is installed, which suppliers provide the equipment, any calibration processes, and when the equipment needs to be replaced to maintain the highest possible quality.
4. Purchasing and Inventory
Properly managing the supply chain is critical in a software system to ensure that raw inputs and other supplies are consistently high-quality. Inventory activities should verify that materials and supplies are stored in a way that protects integrity. Make sure you purchase inventory from suppliers who also follow a quality management system.
5. Process Control
Process control encompasses quality management processes for testing, including:
- Method Verification
- Process Validation
If you’re struggling with process control, a quality management software can dramatically improve internal efficiencies. With PERFEQTA, you can document all processes related to each step of quality control, such as the testing required for verification and validation or internal audits.
6. Information Management
The laboratory produces many forms of information, including quality control test results, maintenance reports, and other data. Along with that, the lab processes patient information such as medical exams, results, and more. This data needs to be managed in a way that ensures all information is accurate, secure, confidential, and accessible to individuals with the right privileges, such as lab managers and leadership.
7. Documents and Records
Documents are a similar concept to information management, and there’s a significant overlap between these categories. One of the most essential lab documents is standard operating procedures (SOPs) to create a standard for each process. Document control must be available at the point of work, maintained, accurate, and secure. Finding the right quality management software for document control should be a mission-critical focus for any growth-oriented life sciences company.
8. Occurrence Management
An “occurrence” is any error or non-conformance. An enterprise quality management software can help you detect these issues and facilitate investigations to discover the root cause and prevent reoccurrence. A laboratory enterprise quality management software can also assist you if you’re going through an audit, as it’s much easier to document these occurrences and what you did to fix them.
Assessment involves comparing laboratory performance to internal standards for quality or external data sets, such as industry benchmarks. Assessments include the activities of lab or quality management employees, internal auditors, or external inspectors.
10. Process Improvement
A quality management system should support the continuous improvement of laboratory processes. Components of the QMS which support improvement can include quality assurance, quality control, and CAPA (occurrence management). We recommend investing in training management software to build and activate major improvements to internal processes.
11. Customer Service
Customer service is the ultimate goal of a laboratory. A laboratory’s quality management software should support operations that consistently provide a positive customer experience through the production of consistently high-quality products or other missions. The laboratory needs to understand the customers and their needs and use customer feedback for improvement.
12. Facilities and Safety
Laboratories need a comprehensive set of procedures and standards to ensure a safe, secure, and clean environment. This includes physically securing the lab, containment procedures for hazards, worker safety, and ergonomics. PERFEQTA’S quality management software does it all!
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 QMS apps available
Automatically track all of your QC data and compare against pre-defined criteria. Detect failures immediately with alerts when conditions are triggered, allowing you to make the best decisions based on timely information.
Easily manage equipment maintenance and calibration while monitoring accuracy, inventory, suppliers and the entire quality control process with PERFEQTA's customizable lab operations software modules.
Confidently ensure compliance with the FDA’s GMP, GDP, GLP, and GCP guidelines. PERFEQTA chooses to work with highly-regulated organizations, and has been the leading GxP software since 2005.
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.”
Frequently asked questions
What is quality control?
Quality control is defined as setting up standards and testing to ensure things like a product or service are done organized and appropriately. An example of quality control will be the department in a manufacturing company that inspects each item to make sure everything is properly working. As a result, the products are up to the desired standards.
What are the 6 quality systems?
The six systems in this inspection model are quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.
Why is ISO certification required?
ISO certification certifies that management systems, manufacturing processes, services, or documentation procedures have all the standardization and quality assurance requirements.
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!