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Quality Assurance Practices

Producing the Highest Quality Data Possible from Each Sample

Ocean Ridge Biosciences understands that biological samples can often only be obtained once, especially samples that are derived from human and animal models. In order to provide the maximum protection of all samples, ORB has implemented a set of standard practices that minimize the probability of sample losses, degradation, and the production of sub-optimal data sets. These common-sense practices are also described in the sections below.
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Real-time qPCR assays
Immunoassays

Organization
One of the main factors in producing consistently reliable data sets is highly qualified and properly trained personnel. ORB scientists have extensive experience in molecular biology and are also subject to a 3-part training program for each Standard Operating Procedure (SOP) that has been implemented.

Facilities
When working with low-copy templates and sensitive assays, the cleanliness of the laboratory is of the utmost importance because airborne contaminants such as dust can negatively impact such analyses. Housekeeping tasks are performed on a daily and weekly basis at ORB to reduce airborne and other possible sources of sample contamination. ORB utilizes a physically separated negative pressure laboratory (NPL) when working with amplified products to prevent the contamination of unamplified precursors.

Equipment
ORB’s equipment, scientific instruments and facilities are initially qualified for use during an Installation, Operational, and Performance Qualification (IP/OQ/PQ) program; and also undergo a continuous validation, calibration and maintenance schedule.

Standard Operating Procedures
SOPs ensure batched samples, or samples submitted at different times, undergo the same treatments and procedures for consistent, comparable results. ORB has instituted a documented SOP approval process and also requires that technical staff undergo an in-house, SOP-specific training program, prior to commencing client experiments.

Reagent & Solutions

  • Certified nuclease-free
  • In-house validation prior to release for client projects
  • Lot uniformity whenever possible
  • Pilot assays document lot and instrument performance where client samples are limited

Records & Reports

  • All experimental data, protocols, and reports are archived indefinitely in an on-site server which is backed up weekly
  • Confidential materials are stored in restricted access locations

Project Planning
Scientists at ORB work closely with clients to select experimental designs, laboratory methods, and analytical tools that will ensure the highest probability of achieving project goals.

  • Before sample processing begins a written Project Processing Plan must obtain approval by the project manager, senior scientific staff member, and sales manager
  • Clients are provided written updates at critical junctures and on a weekly basis

Specimen/Sample Tracking
Upon arrival at ORB, the condition and type of received samples are immediately determined, and samples are maintained at appropriate temperatures (ice or dry ice) during the receiving process.

  • Samples and intermediate products are assigned unique ORB-IDs
  • Sample tracking maintained with digital and hard copy logs
  • Parsimonious sample consumption limited to <60% of available material

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Data Analysis Packages
To the greatest extent possible, ORB utilizes computer scripts and macros to automate data processing and analysis tasks. Following the assembly of a data analysis report, the data scientist utilizes automated scripts and template-driven quality worksheets to validate the integrity of results by cross-referencing final data to raw data and sample processing records as well as checking to ensure all data processing steps where conducted according to standard operating protocols and the specifications of clients.

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GLP real-time assays and immunoassays available!

Contact Us to discuss how ORB can support your GLP research needs.