Quality Services
At PMRS, we support every manufacturing or analytical project with expert quality assurance and regulatory control. We ensure full cGMP compliance through continual internal, client, and FDA audits. Without exception, we meet and exceed all expectations for quality and regulatory compliance in our facility and systems.
As your quality partner we provide support in:
- Standard Operating Procedures development
- Document Systems development
- Off-site Quality Assurance
- IQ/OQ/PQ Validation support
- Laboratory Information Management System
- Raw Materials, In-process, Finished Product Release
- Real Time CoA
- Stability Support
- Product Annual Review
- DMI Compliance Suite: Inventory Management, Equipment Tracking, Skills Training, Electronic Batch Records (validation in process)
- Training: New Employee, Weekly cGMP, Monthly safety, SOP's, Individual skills
- Emphasis on Information Systems Solutions
LabWare LIMS at PMRS:
Our unique configuration of LabWare LIMS will enable PMRS to increase our quality and efficiency while becoming a paperless lab. The following systems and processes will be performed using LabWare LIMS:
- Our Release, In-Process , Raw Materials, and Micro testing along with Stability Studies, will be setup, controlled, tested, and reported using LabWare LIMS.
- Training and SOP requirements will be captured in LabWare LIMS. Analysts will only be able to use equipment or perform tasks that they are properly trained in.
- As with the Training and SOPs, similar controls will be placed on Equipment. Analysts will only be able to use equipment that is calibrated or standardized as per SOP requirements.
- Equipment and existing systems will be Integrated into LabWare LIMS to allow data to be transferred and recorded electronically.
- Report and CoA generation will be customizable to satisfy regulatory, client, and internal needs.
We use OpenLab for documents and records management:
- Secure 24/7 web access for clients to protocols, reports, raw materials, batch records, CoA, Chromatograms
- Over 800,000 files
- Over 400 SOPs
- Over 600 in-house monograph
We use TrackWise Quality Management software:
- Job Tracking
- Change Control
- Laboratory Investigations, Deviations, Failure Investigations
- Audits (internal, client, regulatory)
- Corrective And Preventative Actions (CAPAs)
We perform internal audits of our quality system and host client audits on a regular basis. Please contact our Quality Management department to arrange a visit.
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