• Manufacturing Systems

 
 
 

Manufacturing Systems

USDM Life Sciences provides Strategic Planning and Compliance & Validation Execution and Remediation Services for Manufacturing Systems in support of commercialization projects, capacity expansions, site moves, validations, and quality and compliance projects in order to produce and market products and meet regulations. USDM has worked on most types of Pharma, Biotech and Medical Device instruments and equipment.

Our manufacturing team uses efficient, value-based approaches that have been helpful to many industry leading companies. Examples include; using a Risk Based Approach; Outsourced Managed Compliance Services; Validation On-Demand and more. USDM can provide planning, project management, qualification, validation and commissioning of pharmaceutical, biotechnology or medical device manufacturing facilities, equipment, systems, utilities, test instrumentation and computerized systems to support full product development from conception to commercialization. We can help reduce the compliance workload, reduce cost, save time and, simultaneously enhance the level of compliance.

USDM has extensive skills and experience in providing rapid, low-cost and effective validation services for computerized manufacturing systems and equipment. Our qualification/validation services include support for engineering change control, factory acceptance testing, site acceptance testing, and the standard validation deliverables (e.g., FRS, SRS, URS, IQ/OQ/PQ, validation plans, risk assessments and validation summary documents). USDM consultants are domain experts providing professional services that meet regulatory and business demands in compliance with current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEPs), Good Laboratory Practices (GLPs), ISO standards and Instrument Society of America (ISA) Standard S88/S95, batch production standards.

Call us today, and tomorrow we'll put market-leading manufacturing automation compliance solutions in the palm of your hand.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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