Laboratory Validation

Sequence, Inc. has extensive experience validating laboratory equipment, instruments, and methods for the biopharma and medical device industries. Whether you are constructing a new laboratory, relocating an existing one, or simply purchasing a system to enhance your capabilities, Sequence is here to provide services for your quality and compliance consulting needs. Sequence has life science consultants with varying educational backgrounds including bioanalytical, chemistry and engineering. With each quality and compliance effort, our consultants begin with an initial consideration of the technical complexity of the lab system, degree of customization, and intended use by our client. This allows us to implement an effective, risk-based approach during each equipment or instrumentation validation effort. Testing performed by Sequence consultants provides documented evidence that the system is installed properly, performs accurately, and produces reliable data. Our consultants are trained in the use of numerous test instruments and equipment utilized during validation testing such as Kaye Validator 2000 and Veriteq data loggers. We also offer qualification templates and procedures to improve the effectiveness and efficiency of our clients’ laboratory equipment validation activities.  Deliverables we offer include, but are not limited to:

• Supplier Assessment
• Validation Plan
• Requirements and Functional Specification
• Risk Assessment
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Final Reports
• Traceability Matrix
• Validation Summary
• Change Control
• Periodic Review
• Auditing
• Decommissioning Protocol

Our Lab Systems Experience

Laboratory Equipment System Portfolio:

• Centrifuges
• Refrigerators
• Freezers
• Incubators
• Water Baths
• Autoclaves
• Isolators
• Robotic Pipettors
• Stability Chambers
• Ovens
• Vessels
• Tanks
• Cold Rooms

Laboratory Instrument Portfolio

• DNA Characterization Systems
• Microbial Detection & Identification Systems
• Microplate Readers
• Viable Cell Counters
• Microscope Camera Systems
• Real-Time PCR Systems
• Particle Counters
• Spectrophotometers
• SEC-MALLS
• TOC Analyzers
• Titrators
• Densitometers
• Atomic Absorption Systems
• HPLC
• UPLC
• FPLC
• GC
• LCMS
• Capillary Electrophoresis Systems
• FT-IR
• Fluorometers
• Nephelometers
• Cyanide Analyzers
• Gel Chip Analyzers
• Polarimeters
• Gel Chip Analyzers

Instrumentation & Equipment Validation Testing for Regulated Labs Nationwide

Sequence, Inc. has worked on various lab equipment and analytical instrument compliance projects for life science companies across the US, Canada, Puerto Rico and beyond over the years. Past projects include retrospective legacy validation initiatives (including an initial gap analysis), prospective/concurrent validation of individual systems, laboratory startups, facility relocations, new product/product changeover testing enhancements, laboratory decommissioning, electronic data retention/archival initiatives and much more. Contact us today at 855-844-7171 to learn more about our lab compliance services for pharmaceutical manufacturers and other regulated laboratory facilities. We partner with each of our clients, determining their strengths, weaknesses and overall facility objectives to produce the best possible return on investment. Sequence, Inc.’s life science consultants offer lab instrument and method validation, lab relocation, and other services to clients nationwide. Proudly serving the Northeast, Southeast, West Coast, Midwest, Canada and Puerto Rico as well as various international clients.