Cheshire Scientific Services is a versatile, experienced site-based scientific service provider who specialise in laboratory relocation or refurbishment projects; equipment qualification and validation, and analytical services in GMP and GCP facilities.
Cheshire Scientific Services specialise in the validation of pharmaceutical equipment, analytical methods, and IT business systems. Our service offers tailored Pharmaceutical validation solutions for new installations, re-validation, and remediation efforts. Validation is required for all these to demonstrate compliance to company procedures and national health authority inspectors.
Data Integrity Remediation
Data Integrity is a key area that health authority inspectors will want to inspect within your GMP Facility. Legacy manufacturing and laboratory equipment are often prone to vulnerability within this area. We can help you assess and mitigate the risk that these older systems pose to your business.
GMP Laboratory Equipment
Analytical Laboratory Instrumentation used within chemical, microbiological and Bio-pharmaceutical analysis, and their software need to exist within a suitable validation life cycle. We are experienced with many types of Laboratory equipment and software. We can assist your business:
- Upgrade or replace equipment
- Integrate existing equipment to increase productivity and reduce paper-work, whilst increasing compliance.
- Validate new equipment
- Thermal-mapping of controlled temperature units
Computer System Validation (CSV)
We only validate systems to the current 21 CFR Part 820, 21CFR Part 11/ EU Annex 11 & GAMP 5 standards, providing any or all of the below deliverables for your facility:
- System/Software Requirements Specification
- Network Diagram
- Risk Analysis and 21CFR Part 11/EU annex 11 compliance analysis
- Design & Functional Specification
- Full validation protocol generation, execution or review
- Requirements Traceability Matrix and Validation reporting
Pharmaceutical Manufacturing systems
The correct, compliant initial and on-going validation of either Automated or Standalone manufacturing systems is a critical part of any GMP facility. The increasing complexity of modern-day medicines often require elements of tailored solutions in order to effectively treat patients with serious illness. Specialist Validation of these systems allow a manufacturing process to operate smoothly in a reproducible manner to allow on-time delivery of medicine to those who need it most. Cheshire Scientific Services can take you through a full validation life cycle to deliver a problem-free process that allows your business to get on with what you’re meant to be doing – making medicine.
To learn more about the services we provide, visit our website here.