Laboratory Qualification
Gencell Technical Services has a team of permanent employees who are available to deliver specific projects relating to the validation and qualification of your Laboratory Facilities, Laboratory Bench Equipment, all IT, Controls & LIMS systems, large-scale equipment and associated utilities.
We have the ability to fast track your time to market, research, clinical trials and manufacturing by delivering innovative solutions whilst adhering to all GLP and GMP regulatory requirements.
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We empower our clients to achieve the success they deserve by delivering a transparent and effective solution.
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We specialise in the following:
Clean Rooms
Autoclaves
Temperature Mapping
Bench Equipment
Temperature Controlled Units
Environmental Monitoring
Control & Microbiological Monitoring.
Airlocks and pass-throughs (PAL/MAL)
Clean Utilities
HVAC Systems
Clean & Black Utilities
Gencell Technical Services can offer our clients full engineering and qualification on all facility clean & black utilities, including but not limited to the following;
Clean Utilities
Pure Steam
Purified Water
Water for Injection
Black Utilities
Portable Water
Soft Water
HVAC Systems
Steam
Compressed Air
Gases
Please contact our Technical SME’s to arrange a capability overview and discuss your project. We will design a specific project solution to ensure that your deliverables, budgets and timelines are achieved.
CQV
​The Gencell Technical Services team of discipline specific SME’s, has excellent, referenced experience of delivering Commissioning & Qualification projects to our clients, in the UK and EU.
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We will plan, design and deliver a project plan, whether it’s a short term or long term project, with in depth scope and a high level of technical quality.
We have the discipline specific teams to project manage and deliver, whilst seamlessly working alongside our clients and their internal teams.
We value every project and take pride and ownership, to empower our clients success.
Our teams will deliver a complete suite of documentation including but not limited to the following:
GAP Analysis
Risk Assessment
Validation Protocol Generation & Execution (DQ,IQ,OQ,PQ)
VMP Development
User Requirement Specifications
SOP Generation
FAT & SAT
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Please contact our Technical team to arrange a capability overview.
CSV & Automation
Gencell Technical Services have internal teams of specialists who can deliver CSV & Automation projects for our clients.
With previous and current experience delivering CSV & Automation projects in the UK and EU, we typically specialise in delivering GxP compliance adhering to all Good Automated Manufacturing Practices.
We specialise in the following:
Computer Systems Validation
IT System Qualification
Data Integrity Solutions
Laboratory Information Management Systems
ERP Solutions
Programmable Logic Controller (PLC)
SCADA
Delta V
Project Controls
Gencell Technical Services specialize in providing our clients with expert project controls management.
Lead by our technical SME’s we have referenced experience of delivering project controls expertise within multiple markets across the UK and EU, with current project engagement within Mission Critical Data Centres and Life Science projects.
Our team of project controls experts are available for short or long-term projects and can be site based in the UK or any EU location
We deliver expertise within the following areas of Project Controls:
Project Planning
Risk & Mitigation Management
Stakeholder Engagement
Scheduling
Cost Control Management
Document Control
Change Control Management
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Please contact our Project Controls leads to discuss arranging a face to face meeting and capability overview.
Audit Readiness & Remediation
The Gencell Technical Services works with clients to prepare for inspections from industry specific regulators. We listen to the client requirements, design a strategy for audit readiness and then deliver all remediation activity, post inspection, to ensure successful and safe operations, minimise potential operational downtime and mitigate all risk.
Gencell Technical Services also has a network of collaborating suppliers who we work with regularly, to ensure client confidence and ultimately, project success with Regulatory Audits.
Typical services include the following:
Gap Analysis
Mock Audit Inspections
Pre Inspection Preparation
Document Generation
Post Inspection Remediation Activity
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Please contact us for a discussion on your requirements and a capability overview of the services and solutions we can offer.
Quality Control
Gencell Technical Services has a permanent team of 15 Microbiological QC Specialists who are available to engage with our clients and complete specific, site & laboratory based deliverables, for long or short term projects.
The team are all highly qualified, have project experience within the UK & EU, are all fully trained in aseptic techniques and have experience working in all clean room classifications.
Typical services that our QC Team deliver:
Analytical Testing
Analytical Method Validation
Cleaning Validation
Environmental Monitoring
Formulation and Stability Studies
Medical Gas Testing
Product Quality Control
Laboratory Equipment Validation
