Lab Systems Blog
A lot of times, especially when developing high levels of controls, companies in the industry feel that they need to do testing themselves. More and more companies are outsourcing the testing. The fact is, a trusted vendor can do the calibrations and qualifications. Very often, vendors are the ones that set specifications for qualifications, so they are the best people suited to test. Validation can be done by vendors or contractors. Regardless of who does the work, the company itself is responsible for defending the work. The company is responsible for the pre-approval, review, and the final approval process. When…
If it is a basic instrument, it is best to have it calibrated. It is important to have a set of requirements to say what calibration set test points and ranges are producing data that are considered valid, even if it's not going into a regulatory document or submission. The same process is recommended with regards to qualification. It is best to have met manufacturer specifications before instrument installation. You should do some type of testing, make sure the software works and that it is installed properly; that would go for any basic laboratory equipment. Lab Systems that are not…
Michael Ambrose, Vice President of Lab Services and Solutions at USDM Life Sciences says his approach would be for a calibration or a qualification. For instance, if it's a basic instrument, he’d still want to calibrate it. He would still want to have a set of requirements to say what the calibrations test points and ranges should be and make sure that that system is producing data that I could consider valid, even if it's not going into a regulatory document or submission. The same with qualification. He would definitely have manufacturer's specifications being met before I installed an instrument…
It’s important to be very clear in a Request for Proposal (RFP). If you want validation or training services, specify exactly what you are looking for in the request. For example, some companies have validation staff, but may not have a validation leader. You may want to specify that you only need a validation team leader. If you will need training services, include who will need to be trained. You may only need help training the trainers or you may need training for an entire department. USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a…
It’s important to understand the capabilities of the new LIMS and develop a baseline of requirements at the beginning of the project.  It’s a good idea to have representatives from every department that will use the new LIMS participate in establishing the baseline of requirements, because departments within a company often have different requirements.  Kathleen Warner, Vice President of Project and Program Management at USDM Life Sciences says requirements for one particular LIMS project she worked on had to be revised four times because company representatives learned about new capabilities of the lab system during the project. USDM Life Sciences offers…
If you have a Legacy LIMS system, talk to your Legacy vendor.  Another good method is to search the Internet for articles that discuss LIMS.  Do a search on the Internet for “top 10 LIMS vendors in regulatory environment.”  You will see some lists of current LIMS vendors as well as articles that discuss the best LIMS vendors. USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.
The time it takes to implement a new LIMS/Lab System depends on how big it is, how many users you have, whether you are going with an off-the-shelf system or a customized system.  It’s not unheard of for a LIMS system implementation to take over a year, from the time a proposal is requested to completion. USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.