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 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
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
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, are setup, controlled, tested, and reported using LabWare LIMS.
- Training and SOP requirements are captured in LabWare LIMS. Analysts are only able to use equipment or perform tasks that they are properly trained in.
- As with Training and SOPs, similar controls are placed on Equipment. Analysts are only be able to use equipment that is calibrated or standardized as per SOP requirements.
- Equipment and existing systems are Integrated into LabWare LIMS to allow data to be transferred and recorded electronically.
- Report and CoA generation are customizable to satisfy regulatory, client, and internal needs.
We use TrackWise Quality Management software:
- Job Tracking
- Change Control
- Laboratory Investigations, Deviations, Failure Investigations
- Audits (internal, client, regulatory)
- Corrective And Preventative Actions (CAPAs)
Bedrock Values
Our Quality Assurance
We achieved and maintain our high standard of quality by:
- Holding closely our core value of Quality
- Our commitment to quality is an integral and measured part of everything we do.
- Quality is the responsibility of each employee.
- Being indispensable to our customers by:
- Solving problems through our competence, expertise, accessibility, and courtesy.
- Knowing our customers and their needs.
- Defining end-points and the road to success.
- Identifying, anticipating, and preventing problems
- All projects include appropriate design control and quality planning.
- We maintain continuous compliance to all regulatory and international standards.
- Safety is critical to all aspects of our business.
- Striving for Continuous Improvement
- All employees receive continuous training in:
- Appropriate skills
- Current Good Manufacturing Practices
- Standard Operating Procedures
- Projects and services are evaluated for opportunities for improvement before, during, and after execution.
- Cross-functional communication is mandatory.
- All employees receive continuous training in:
IT Services
Information Technology at PMRS provides more than just end-user support. With a mix of technology, project management, and regulatory compliance skills, the Information Technology department is focused on implementing business improvements throughout the facility. This includes a heavy focus on information security and protecting PMRS’s and our clients’ intellectual property.
We maximize productivity and efficiency of other departments at PMRS using:
- Process improvements
- System improvements
- Cutting-edge technology
Our Information Technology department interfaces with the Manufacturing, Analytical, and Quality Assurance departments.
Integrated Systems:
- Document Management, Chromatography, and Data Acquisition – OpenLAB (Agilent Technologies)
- Electronic Content Management
- Chromatography Data System
- Laboratory Information Management System – LabWare
- Manufacturing Execution System – Syncade (Emerson Process)
- Electronic Batch Records
- Quality Management System- TrackWise (Sparta Systems)
- Change Control, CAPA, and Investigation and Shipping Tracking
- Facility Control/Monitoring