Validation & Qualification Services
Trust, Customer Service, Convenience, Cost Savings
Navigating the ever-changing regulatory environment is tedious, expensive, and time-consuming. Regulators want to know that
you’re doing all you can to ensure the quality, safety, and efficiency of your products. At Wave Solutions, we offer a wide variety of
Validation and Qualification services that meet compliances from FDA Regulation, EUMDR, ICH Guidelines, ISO Standards, PDA
Guidelines, ISPEC, ASTEM, DSCSA and many other standards from APAC Regions, European Union and LATAM Regions.
Trust our
industry experts, with decades of industry experience and are dedicated to delivering high-quality Commissioning, Qualification and Validation services.
Convenience
We offer flexible scheduling and service options to minimize cost and disruptions to your daily business operations.
Customer Service
We work closely with your on-site team to develop a protocol specific to your operations and validation requirements.
Cost Savings
Being in compliance is
more affordable than being out of compliance. By partnering with us, you can save on unnecessary expenses.
Compliance Activities & Services: End to End - Systems Implementation including Requirements Gathering, Vendor Management, Design and Development, Validation and Testing Release Management, Change Control Management, Continuous Risk Assessment and Protocols development and Equipment Qualification Services
When it comes to validation, we focus on verifying that your equipment does what the manufacturer says it will do. Our team performs three types of testing to ensure that your equipment is installed properly, functions correctly, and operates as required
by your specific needs.
- Validation Master Plan (VMP): This document will ensure the direction, scope and plan for the project execution.
- User Requirements Specification (URS): This URS document will capture the business needs and high-level activities business is interested to achieve through the system implementation.
- Functional Requirements (FRS): This FRS document will ensures the system requirements are captured with system
level or granular details or engineering specifications for equipment required for the build. - Functional Risk Assessments (FRA): This FRA document will capture the failure modes, consequences and mitigation strategy for the Risk Identified for each functional requirement.
Installation Qualification (IQ)
This verifies that the unit is
installed properly, checking
voltage, proper levelling, etc.
Operational Qualification (OQ)
We test all of the features of a unit, such as control panel, switches, alarms, and 24- hour mapping for temperature units.
Performance Qualification (PQ)
we ensure that the unit operates as you require it to work, customizing our approach to define the scope of work.
Validation Services Offered
At Wave Solutions, we offer a comprehensive range of Validation & Qualification services to meet the diverse needs of our customers. Some of the services we provide include:
Computerized Systems:
- LIMS (LabVantage, LabWare, Star LIMS )
- LabX
- Syncade MES
- Oracle EBS
- SAP MES
- Salesforce.com
- Serialization – Track and Trace
- Trackwise
- Veeva Application
- Medidata
- ARGUS Safety
- Tetra Science
- CCM Application – IBM Maximo & Blue Mountain RAM Vaisala
Our Successful Clients
At Wave Solution, we are proud to have helped numerous clients achieve their goals and streamline their processes. Our team of experts has worked with companies of all sizes and industries, providing customized solutions that meettheir unique needs. From startups to Fortune500companies, we have a proven track record of success.
Startups
We are passionate about helping startups get off the ground and succeed. Our team has worked with numerous startups, providing them with the tools and resources they need to grow and thrive.
Corporations
We have also worked with large corporations, helping them improve their processes and become more efficient. Our team has extensive experience working with complex organizational structures and addressing the unique needs of each department.
Small Businesses
We understand the challenges small businesses face and are dedicated to helping them succeed. Our team has helped numerous small businesses improve their processes and increase their revenue.
Equipment
- Control Temperature Units (CTus) such as Refrigerator, Freezer, and Cryopods, Ovens, Ultra Low Temperature Freezers using
Thermal Mapping Qualification Services - SIP and CIPs Qualification Services
- Cleanroom Qualification, Stability Chambers, Environmental chambers, RABS Systems, Isolators, and Fill finish Qualification
Services - Vial Washers, Parts Washers, Depyrogenation Tunnels, Autoclave & Lyophilizer Qualification Services
- Laboratory Bench-Top Instrument Qualification Services based on USP 1058
- Warehouse, Material Management, and Temperature Mapping Qualification Services
When it comes to validation, we focus on verifying that your equipment does what the manufacturer says it will do. Our team performs three types of testing to ensure that your equipment is installed properly, functions correctly, and operates as required by your specific needs.
Installation Qualification (IQ)
This verifies that the unit is installed properly, checking voltage, proper leveling, etc.
Operational Qualification (OQ)
We test all of the features of a unit, such as control panel, switches, alarms, and 24- hour mapping for temperature units.
Performance Qualification (PQ)
We ensure that the unit operates as you require it to work, customizing our approach to define the scope of work.
Improve Program Efficiency
with Paperless Validation Services
At Wave Solutions, we offer an enhanced compliance process through our Paperless Compliance Services. With online collaboration tools, convenient electronic document delivery, and an accessible database for record retention, you can experience faster cycle times and improved accessibility to your important documentation. Take advantage of our paperless compliance services today.
GXP, GMP Compliance Validation Services
In the interest of safety, purity, and effectiveness, pharmaceutical and life science industries must comply with the FDA’s Good Manufacturing Practices. Our Validation Services for GMP compliance allow manufacturers, processors, and distributors to document and evaluate the practices that support consistent production and quality control.
Requalification (RQ)
Ensuring that the equipment and systems continue to meet the required standards after an initial qualification.
Operational Qualification (OQ)
Testing all the features of the equipment, such as alarms, control panels, and functionality.
Requalification (RQ)
Ensuring that the equipment and systems continue to meet the required standards after an initial qualification.
Operational Qualification (OQ)
Testing all the features of the equipment, such as alarms, control panels, and functionality.
Ensuring FDA GMP Regulatory Compliance
Our experienced technicians collaborate with your quality assurance teams to
successfully complete the testing and reports that validate your production and
laboratory equipment. We have the foundation of knowledge to help you meet GMP
requirements and ensure that there is control over your equipment to maintain
product quality.
Pharmaceutical Validation Services
As a pharmaceutical professional, ensuring the product quality, patient safety, and product efficiency of your drug products is crucial. Pharmaceutical validation provides documented evidence that your systems, facilities, and processes perform their intended functions according to established specifications. At Wave Solutions, we offer distinct advantages to the manufacturers of finished pharmaceuticals and components.
Validation Engineers
Our validation engineers have
extensive technical expertise in the pharmaceutical industry.
Qualification, Validation,
Revalidation
We can assist in the qualification, validation, revalidation, and calibration of equipment.
Calibrated
Instrumentation
We have access to calibrated
instrumentation and superior
standards to ensure accurate results.
Validation Documents
We provide detailed validation
documents for your records and compliance purposes
Quality Assurance of Pharmaceutical Products
At Wave Solutions we understand the importance of quality assurance in the pharmaceutical industry. Our validation capabilities are designed to
meet FDA regulations and ensure that your systems, facilities, and processes operate as intended. We offer flexibility in scheduling and can follow your plan or write a precise protocol that meets your specific requirements.
FDA Validation & Compliance Services
Wave Solutions can help you meet FDA validation requirements related to your laboratory and process equipment.
We believe in the equipment lifecycle approach, providing assistance with installation, preventive maintenance, calibration, re-qualification, and end-life activities. Our goal is to ensure that your systems, processes, and equipment consistently deliver quality products while complying with regulatory standards.
Full Life-Cycle Validation
We support you throughout the equipment life-cycle, from installation to end-life activities.
Equipment Qualification
We perform FDA qualifications to confirm that your equipment is properly installed and
functioning.
Protocol Development
We can write detailed protocols and plans for your validation processes, ensuring accurate results.
Validation Services
We offer installation, operational, and performance qualifications for pharmaceutical practices.
Documentation of FDA Compliance
By partnering with Wave Solutions, you can obtain scientific evidence demonstrating that your equipment operates as prescribed and generates quality products consistently. We have a proven record of expertise in complying with a full range of cGMP and regulatory requirements. Experience flexibility in scheduling and service options that take into account your budget and scheduling demands.
Validation Services Offered
At Wave Solutions, we offer a comprehensive range of validation services to meet the diverse needs of our customers. Some of the services we provide include:
- Refrigerator, Freezer, and Cryo Thermal Mapping Validation Services
- Oven Temperature Mapping Validation Services
- Stability Chamber and Incubator GxP Mapping Validation Services
- Autoclave Validation Services
- Laboratory Bench-Top Instrument Validation Services
- Warehouse Mapping Validation Services
Ensuring FDA GMP Regulatory Compliance
Our experienced technicians collaborate with your quality assurance teams to successfully complete the testing and reports that validate your production and laboratory equipment. We have the foundation of knowledge to help you meet GMP requirements and ensure that there is control over your equipment to maintain product quality.
Pharmaceutical Validation Services
As a pharmaceutical professional, ensuring the quality, safety, and efficiency of your products is crucial. Pharmaceutical validation provides documented evidence that your systems, facilities, and processes perform their intended functions according to established specifications. At Wave Solutions, we offer distinct advantages to the manufacturers of finished pharmaceuticals and components.
Validation Technicians
Our validation technicians have extensive technical expertise in thepharmaceutical industry.
Qualification, Validation, Revalidation
We can assist in the qualification, validation, revalidation, and calibration of equipment.
Calibrated Instrumentation
We have access to calibrated instrumentation and superior standards to ensure accurate results.
Validation Documents
We provide detailed validation documents for your records and compliance purposes.
Quality Assurance of Pharmaceutical Products
At Wave Solutions we understand the importance of quality assurance in the pharmaceutical industry. Our validation capabilities are designed to meet FDA regulations and ensure that your systems, facilities, and processes operate as intended. We offer flexibility in scheduling and can follow your plan or write a precise protocol that meets your specific requirements.
Project Management:
Effective project managementis critical to the success of any business. At Wave Solution, we offer comprehensive project management services to help you streamline your business processes and achieve your goals. Our team of experts will work closely with you to develop a customized plan that fits your unique needs and budget.
Our services include
- Project planning and scheduling
- Resource allocation and management
- Risk management and mitigation
- Cost and budget management
- Communication and stakeholder management
- Quality assurance and control
Why Choose Us?
With our project management services, you can rest assured that your projects will be completed on time, within budget, and to the highest standards of quality. Contact us today to learn more!
Quality Assurance Services
Wave Solution understands the importance of quality assurance, which is why we offer comprehensiveQA services. Our specialists ensure that your products and applications meetthe required quality standards before they are launched. Our services include testing automation, performance testing, security testing, functional testing, and user experience testing.
Functional Testing
Ensure that your enterprise applications and products work as intended with functional testing, which involves testing individual functions of your software product.
Performance Testing
Ensure that your products and enterprise applications work promptly by testing their performance under various loads and conditions.
Security Testing
Gain confidence in the security of your enterprise applications and products by assessing the software against potential attacks and breach situations.
User Experience Testing
Ensure that your products and applications provide the best user experience possible by conducting user experience testing, which involves testing usability, user interface, and overall user satisfaction.
Contact Us
To learn more about our IT services and to find out how we can help your business grow, please contact us today.
| Phone: | 1-800-555-5555 |
| Email: | info@wavesolution.com |
| Address: | 123Main Street, Anytown USA |