Quality Solutions

Vigilant Bioservices' sister company, Quality Solutions, LLC, is a turn-key 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 these core areas.

Biostorage

In 2009, the principals of Quality Solutions saw the opportunity to provide an offsite biostorage solution for their customers that accommodated their needs better than other solutions on the market. Vigilant Bioservices was built with GMP principles and state-of-the-art biorepository redundancy.

Design/Engineering

Vigilant Bioservices can assist in establishing requirements for your manufacturing facility while identifying appropriate facility solutions. Our experience with new and retroftted facilities allows us to recommend process utility changes, design changes, confirmtimelines, and identify suppliers that will keep projects on time and within budget.

Our involvement in the design, equipment selection, construction, commissioning, and start-up process ensures that validation activities are streamlined, therefore substantially reducing costs and saving time. This Quality by Design approach gives clients an advocate during the design and construction phase who considers quality and CGMP compliance from the conceptual design phase through project turnover.


* Design Services
* Construction Management
* Commissioning
* CGMP Compliance & Optimization

Validation

Quality Solutions offers a complete range of services to fit the needs of your company ranging from individual pieces of equipment to entire facility projects.

* Master Validation Planning
* Project Management
* Equipment
* FAT/SAT
* Facilities
* Software
* Sterilization Cycle Development & Cleaning
* Shipping & Packaging
* Validation Experience

Compliance/Regulatory

An effective Quality System should contain robust and practical components that are engineered with a clear understanding of all related regulations and guidelines. We can provide the essential services needed to create, improve, or refine your Quality System. Vigilant Bioservices specializes in helping clients apply CGMP principles to their entire Quality System and workflow by reviewing and strengthening individual components including Logistics, Manufacturing, QC, QA and Regulatory.

* Master Planning
* Regulatory Support
* GxP and Compliance Training
* Gap Analysis/Impact
* Assessments
* SOP Development
* Vendor/Supplier Quality Auditing

Cleanroom

Testing and monitoring of your Cleanroom, HEPA filters, and Biological Safety Cabinets/Laminar Flow Hoods/Clean Benches/Fume Hoods must occur on a routine basis to guarantee personnel safety and reduce risk of product contamination. Vigilant Bioservices can create a testing protocol/sampling plan for the certification of your Cleanroom while providing the necessary testing services to manage certification and on-going monitoring requirements.


* HEPA/Laminar Flow Certification
* Cleanroom Qualification – ISO14644
* Environmental Monitoring and Sampling
* USP<797> Compliance and Testing

Support

Vigilant Bioservices can alleviate the need to hire multiple vendors to complete a single project. Our wide variety of support services including GxP Training, Quality Assurance and Compliance Consulting, Project Management, Equipment Repair and Maintenance, and Lab Environmental Health and Safety can reduce the time spent searching for multiple vendors. Vigilant Bioservices' relationship with qualified vendors brings the necessary experience to your project at reduced costs.


* Calibration
* Equipment Repair and Maintenance
* Lab Environmental Health and Safety

VIGILANT BIOSERVICES

The UMB Biopark
801 W. Baltimore St., Suite 303
Baltimore, MD 21201

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