Laboratory Informatics
Cost-effective laboratory validation and compliance solutions.
Laboratory Validation & Compliance
We offer a complete suite of laboratory validation and compliance services from our Laboratory Informatics COE team who retain extensive laboratory domain, regulatory compliance, and risk management expertise. As a market leader in providing best practice regulatory compliance solutions to the Life Science industry, we can assist you with attaining:
- A uniform set of instrument qualification protocols typically found across different labs, departments and sites.
- Protocols matched to your configuration and intended business use.
- Reduced time between procurement and commissioning into production.
- More meaningful and defendable validation documentation with a higher level of regulatory acceptance by FDA, HPRA, MHRA and other regulatory bodies.
- Enhanced confidence in instrument/system performance and reduced costs in maintenance post “go-live”.
- Instrument Integration.
- Corporate Installation Partners.
- Legacy Lab system decommission.
Laboratory Technical Support
Todays labs are facing increasing pressure and demands to innovate and increase lab efficiently while addressing the regulatory controls for both current and legacy systems. To help meet corporate goals and tighter deadlines for release and ensure compliance to DI controls through operations, IRLCA have built out a Lab Tech Support Service Group working under our Laboratory Informatics COE. This combination provides unchallenged, extensive laboratory domain, regulatory compliance, and risk management expertise.
As a market leader in providing best practice regulatory compliance solutions to the Life Science industry, we can assist you with attaining the following, working in a combination of on-site or remote:
- DI Controls / Lab system Kiosk Solutions.
- Network, Domain, AD Setup.
- Instrument Integration.
- Windows Upgrade Services.
- Protocol / Utility Validation.
- Segregation of duties by access controls.
- Audit Trail Reviews.