Services

We can provide full-service assistance through every step of bringing your laboratory or instrument on-line:

Instrument Selection and Purchasing
Equipment Setup
Method Development and Validation
Creating Standard Operating Procedures (SOPs)
Staff Training
Regulatory and Compliance Reviews
Data Review
Hazard Analysis and Critical Control Points (HACCP)
Annual Auditing

 

Instrument Selection and Purchasing
Depending on the type of testing necessary, there are many options available to acquire data. We’ll go over the advantages and disadvantages of all instrument types, including capital costs, maintenance costs, sample throughput and feasibility with LIMS systems.

Equipment Setup
Properly functioning equipment is essential for any laboratory. Instrument qualification and operating qualification (IQ/OQ) is the most important first step for your laboratory’s operation. Your instruments need to do what you say they do!

Method Development and Validation
The single most important thing a lab can do is ensure robust and extensive method validation. Without it, quality, robustness and accuracy of data produced by the lab is put into question. We can help validate instruments and methods to World Health Organization standards (pharmaceutical industry quality).

Creating Standard Operating Procedures (SOPs)
Standard operating procedures (SOPs) ensure quality control of your facilities. Chain of custody is extremely important in laboratories. Reproducibility is equally important. Good SOPs ensure both are handled in a defensible manner. Remember, quality is a lab’s best marketing.

Staff Training
Training staff on SOP’s ensures proper functioning of the lab as well as giving your customers peace of mind. We can train all staff to current SOP’s as well as setup internal proficiency training programs to ensure ongoing compliance.

Regulatory and Compliance Reviews
When pursuing certification or accreditation, it is important to be compliant and have a proper quality management system in place prior to auditing. We can fulfill the paperwork review as well as the internal auditing necessary to be ready for any federal or third party audit (CLIA, CAP, ISO etc.).

Data Review
Often after generating your first data, it is helpful to have an extra set of eyes review your data for accuracy. This is a critical step in any quality assurance plan.

Hazard Analysis and Critical Control Points (HACCP)
HAACP is a process control system designed to identify and prevent errors is laboratory function. It is composed of seven principles: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) record keeping, and (7) verification procedures. Having this plan in place ensures no crisis, however large or small, is capable of crippling your business.

Annual Auditing
Ensuring compliance over time is accomplished by annual audits. As regulations are constantly evolving, you must ensure compliance for your customer’s peace of mind as well as your accreditation. We schedule, prepare, and perform annual audits to keep you compliant.