Introduction / Vision
Started in 2001 as a validation and regulatory services provider, Quality Solutions is continually developing a portfolio of services to provide a high-quality, cost-effective solution to the Biotech/Pharma and Healthcare industries. What seperates us from others is that we clearly understand one size does not fit all. This portfolio of service offerings can be tailored to any client project, regardless of size or scope. Our offices in Maryland and Utah have continually allowed us to execute projects globally.
Our USP<797> <800> Services
Quality Solutions is your complete solution to support your Quality and Compliance needs. Combining a range of services we have built our reputation with firms across the regulated industries to become a preferred service provider in the following core areas:
- Calibration
- Cleanroom/HEPA/Laminar Flow Certification/ISO 14644
- Design Services, Construction Management, and Commissioning
- Environmental Monitoring and Hazardous Drug Testing Kits
- Technical Support Services
- USP<797> <800> Compliance
Therefore, in selecting Quality Solutions, you will work with a single trustworthy service firm, which is committed to long-term relationships, quality, and cost-effectiveness.
In providing this array of service offerings, you can expect to receive consistent performance that exceeds expectations and improves cost efficiency by:
- Building long-term professional relationships with qualified staff who evolve with the industry and changing guidelines.
- Providing your company with the necessary expertise to develop, implement, and support your Quality Program.
- Providing timely execution of projects so that your employees can focus on other priorities.
- Reducing redundancies.
“Ensuring a Return on the Cost of Quality”
A 20+ Year Commitment to Quality
Our company is built on three core principles:
- To provide our clients with consistent professional services which yield a return on the Cost of Quality.
- To offer services that complement and add value to the client organization.
- To provide a direct project scope with defined pricing and no hidden or surprise costs.
Dedication to Quality
How does Quality Solutions deliver quality?
Put simply, it’s about our people and their commitment to go beyond expectations. Our staff is trained and equipped with state of the art testing equipment and a dedication to work with you to help reach project objectives. To keep abreast of industry standards and trends, professional development opportunities are a regular part of employment with Quality Solutions. Finally, our employees possess the communication skills necessary to provide critical feedback, analysis, and guidance during the project.
- CETA
- JCAHO
- NABF
- NSF
- USP<795>
- USP<797>
- USP<800>
Quality System
To ensure that we meet the same quality objectives of each client, our management team developed a clear and concise Quality Manual. This document is continually monitored and outlines our internal document control system, vendor/supplier requirements, continual improvement process, training, and corrective/preventative action procedures.
SOPs
As part of our Quality Manual, we have developed SOPs relating to equipment usage, validation procedures, and protocol execution. In the event that the client does not have any procedures in place, our staff uses our approved SOPs to perform functions described in the testing documents.
