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.

Quality Policy:

  • PMRS is committed to providing the healthcare industry manufacturing and scientific services that meet and exceed our customers’ expectations.
  • PMRS ensures customer satisfaction, strives for continuous improvement, and creates value for our customers

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
  • Syncade Compliance Suite: Inventory Management, Equipment Tracking, Skills Training, Electronic Batch Records
  • Training: New Employee, cGMP, Monthly safety, SOP’s, Individual skills
  • Emphasis on Information Systems Solutions

LabWare LIMS at PMRS:

Our unique configuration of LabWare LIMS enables PMRS to increase our quality and efficiency while also being a paperless lab. The following systems and processes are performed using LabWare LIMS:

  • Our Release, In-Process , Raw Materials, and Micro testing along with Stability Studies, shall be setup, controlled, tested, and reported using LabWare LIMS.
  • Training and SOP requirements are 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 1,000,000 files
  • Over 350 SOPs
  • Over 600 in-house monographs

We use TrackWise Quality Management software:

  • Job Tracking
  • Change Control
  • Laboratory Investigations, Deviations, Failure Investigations
  • Audits (internal, client, regulatory)
  • Corrective And Preventative Actions (CAPAs)

Please contact us for more information about the quality services we provide.

Quality Services was last modified: February 26th, 2015 by pmrsinc