delivering excellence in automation, mes and digital ...€¦ · validation (cqv) services....
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Delivering Excellence in Automation, MES and Digital Manufacturing Direct to the Life Science Industry
Powering Patient Health www.zenithtechnologies.com
Our process expertiseLarge Molecule Bulk (Single-Use and Continuous)
Cell Therapy
Gene Therapy
Small Molecule
Solid Dose
Sterile Fill Finish
Medical Device
Packaging
Assembly
Serialisation
01We’ve been operating successfully in Life Sciences for over 20 years. During that time, we have been involved in automating, validating and supporting plants from start-ups through to decommissioning.
We play an integral role in the delivery of life-saving products to patients throughout the world.
+ Founded in 1998
+ Operating across 5 continents
+ 16 offices and growing
+ 100% Life Science focused
+ Over 1 million hours of engineering time delivered annually
+ 900+ people and growing
+ Working with the leading Biotech and Pharmaceutical companies globally
+ Vendor independent Brendan O’Regan,Founder of Zenith Technologies
About usZenith Technologies is a world leader in delivering manufacturing software systems that make Life Science businesses compliant and competitive.
We specialise in Automation, MES and Digital Solutions to improve operational effectiveness. We have experience in delivering over 35 technologies covering: MES, DCS, PLC / SCADA, Historian, PAT, BMS, and other more niche applications. We pride ourselves on being vendor independent.
We build long term partnerships with our customers and are focused on supporting the full system lifecycle.
Helping you reach your digital business goals
Industry 4.0
Data Integrity
Data Analytics
Release by Exception
Cloud
IIOT
Cyber Security
Augmented Reality
Digital Twin
PLM
What we deliver for Life SciencesLife Science manufacturing expertise
Manufacturing optimisation
Performance improvements and reduced costs
Regulatory compliance assurance
Improved operator and process effectiveness
Projects delivered on time and to budget
A highly skilled workforce and knowledge retention
Decreased time to market
System assurance, uptime and efficiency
Measurable project outcomes and ROI
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Digital & Data
Digital DashboardsData Analysis and Prediction
Digital Infrastructure - Connection and Communications
Business Planning & LogisticsPlant Scheduling, Operational Management etc.
MES – Production, Inventory, Quality & MaintenanceWorkflow for Electronic Batch Record (eBR) and Weigh & Dispense
Overall Equipment Effectiveness (OEE)Batch Genealogy, Process Monitoring, Asset Register,
Energy Management & Repairs
AutomationBatch Control
Continuous ControlDiscrete Control
InstrumentationDevices, I/O, Sensors etc.
Where we operate
Introduction
“Digital
Services
Automation
Consultancy
MES
System Integration
Full System Lifecycle Support
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The software you and the team configure will help us make more medicines over the coming years. We cannot bring this therapy to the patients without Zenith.
Director of Global Technical Services,Leading BioTech Company
“ 02Zenith offers manufacturing consultancy to the Life Science industry at all stages of system lifecycles. Zenith provides critical decision support to customers considering plant management and production control projects.
Our experienced consultants are certified and trained to world class standards. We have intimate knowledge of manufacturing systems, extensive process knowledge and over 20 years of experience serving Life Science customers. We are experts at finding innovative solutions to deliver the optimum balance between quality, cost of ownership and technical excellence.
Consultancy
Delivering valueWe help customers justify the ROI, gain project approval, ensure the technology selection is the most efficient, cost effective and well suited to your company’s short-long term goals
We work with customers to remediate issues with in-flight projects, identify and develop training, create robust support frameworks, conduct Cyber Security threat assessments and carry out compliance assessments
We support customers by identifying opportunities for process optimisation through performance or predictive modelling using data analytics. This may involve the use of technologies already deployed or require the design of solutions where needs exist
Delivering benefitsDefine your project roadmap
Plan your project using proven methodology
Leverage our expertise in this field
Ensure project success
Minimise business risk
Improve manufacturing performance
Enable accurate ROI
Increase competitive advantage
The earlier we engage on projects the more successful and effective the outcome. We use an independent voice of experience to contribute to key project decisions.
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Corporate programmes
Manufacturing systems design
Manufacturing systems compliance
Key
Concept Studies
ISA-95/88 Awareness Training
Corporate Strategy Definition
Digital Strategy Creation
Manufacturing Systems Operating Philosophy
Corporate Programme Management
Lifecycle Management Process Definition
Proposed Solution Assessment
Platform Selection
Risk Assessments
Cost / Benefit & ROI / Feasibility Studies
Site OT System Readiness Assessments
Standards, Definition & Governance Assessments
Digital Need Assessments
Technology Risk Assessment
Training Requirements Assessments
Cyber Security Of System Threats Assessments
21CFR Part 11 and Data Integrity Assessments
Vertical Slice Development
User Requirements
Business Process Mapping
OT Structure Infrastructure Design
Project Execution Remediation
Programme Creation & Governance
New Product Introductions
Training Programme Development
Digital Infrastructure Design
Support Service Governance
Support Service Design
Change Management
Process Optimisation through Data Analysis
Compliance Assessment & Remediation Planning
OT Infrastructure Support Design
Awareness Assessment Execution Support
Process optimisation through digital
Operational technology infrastructure
Sustaining support
Our consultancy offering covers:
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At Zenith Technologies, Project and Programme Management is a fundamental, core discipline which we believe is critical to project success. Through our dedicated PMO we foster a culture and awareness of project management throughout the organisation.
Our Project Managers operate to in house Standard Operating Procedures (SOP). The procedures are specifically designed to execute and control System Integration projects. The procedures are based on PMI’s PMBOK® standards and the experience gained from delivering projects over the years.
The procedures have been audited by our Global Life Science Clients on numerous occasions and also by an ISO9001:2008 accreditation authority and are deemed to be best in class.
Zenith Technologies Project and Programme Management approach is based on internationally recognised best practices:
PMI - Project Management Institute
PMBOK® - Project Management Body of Knowledge
PMP® - Project Management Professional accreditation
MPM - Masters in Project Management degree
Diploma in Project Management
We have developed an extensive set of control, reporting and analytical tools:
03Zenith Technologies is one of the foremost and highly respected independent System Integration experts in the manufacturing automation industry, specialising in implementing Automation, MES, and Digital solutions for Life Sciences.
Our success is based on the combined breadth and depth of our proven expertise in software technologies, business systems, platforms, operating systems, hardware and specialist industry requirements.
System Integration Delivering valueAt Zenith, our project delivery excellence is based on the following critical success factors:
Knowledge and implementation expertise across a vast range of global vendor technologies and multiple platforms
Solid methodologies, procedures, processes and standards compliant within a robust QMS framework
A large pool of skilled and trained project managers and engineers with Industry specific expertise
Solutions that provide qualified interfaces to all major control, automation and business systems
Zenith’s global integration capability means customers benefit from 24 hour ‘follow the sun’ engineering
Delivering benefitsWe have a proven track record of integrating all leading industry platforms to deliver user-friendly and accessible applications and solutions. Customers can rest assured that implementing automation projects in partnership with Zenith will mitigate the risk of introducing or upgrading new technology.
Whether customers are looking to implement a new DCS, integrate a PLC with their existing platform or upgrade their SCADA, we have the experience and established knowledge to ensure tangible performance and efficiency in implementing projects across the production control level.
Zenith also has significant integration expertise on leading MES vendor technologies for both full turnkey systems and point solutions such as Traceability and Electronic Batch Record Systems (eBRS).
Where global standardisation is a requirement, we have developed a Global Programme Optimisation Methodology to provide a consistent approach, irrespective of the location.
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Integration CapabilitiesProcess Automation
MES
Historian & Data
Data Analytics
Our experienceZenith’s proven track record in integrating multi-million-dollar automation solutions, is testament to our project management, risk-based approach and culture.
Project managers use a suite of project management tools based on industry best practice. Technical personnel undertake an ongoing programme of continuous professional development, with exposure to a range of technologies and applications.
With offices across three continents and over 20 years’ experience, customers benefit from our global vision yet local focus.
Our longevity and continued growth are testament to the high level of satisfaction customers enjoy when they trust us as their System Integration partner.
Finally, our QMS is ISO9001 certified. Process Control (S88) integration projects and MES (S95) deployments are standards compliant and our personnel are fully conversant with the GAMP lifecycle model.
The Zenith team delivered the scope of this project in an extremely professional manner, demonstrating true ownership in executing the project and it was a pleasure to work with them.
PAS FAT Lead,Leading Pharmaceutical Company
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People Methodology Technology
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Tracking Progress Quad Plot
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04As a leading player in the Life Sciences industry, Zenith Technologies offer a wide range of services and solutions to cover all your requirements in the area of Automation, MES, Digital, Quality Control and Development Lab Systems.
We have over 900 engineers globally available to support, guide and manage your GMP manufacturing systems infrastructure. We are flexible and can be as involved as you need us to be – from taking complete control to assisting with small projects.
ServicesManaged services
Ensure your GMP manufacturing IT systems maintain a validated state
Provides system reliability and continuous improvements through assistance with your NC CAPA change process
Formal quarterly business review (QBR) using key performance indicators (KPIs)
Formal quarterly value statement generation
24/7 Manufacturing IT servicesHigh quality multi-platform engineering support across Automation, MES, Digital and Lab IT Systems
Remote 24/7 incident triage, functional escalation and resolution
Remote service requests, demand management and event management
Professional Placement services
Comprehensive and tailored workforce solutions
Leveraging our significant expertise in engineering and project management
Formal monthly reporting highlighting the services delivered
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Commissioning, Qualification and Validation (CQV) services
Vigorous testing, validation and quality assurance
Facility start up and hyper care activities for single or multiple resources with a defined skill set delivering a loosely defined scope over varying contract time periods
Computer Systems Validation (CSV) programme delivery
Commissioning, Qualification and Validation (CQV) team support
Development of risk-based approaches to testing
Learning & Capability servicesDelivery and generation of customised technology training (Instructor led or eLearning)
Delivery and generation of augmented, mixed and virtual reality training
Facilitation of cross training for multi-disciplined team development
Facilitation of multi-annual graduate and engineering training programmes
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Automation Systems
MES & Digital
QC Lab IT Systems
Establish, keep and refineTransition from CQV to GMP manufacturing
Continuously improving GMP incident response times
High quality root cause analysis
Reduction of repeating incidents with effective CAPAs
Proactive system and event management
Continuously improving service KPIs
Removes the pain fromFront line manipulation shift support
Resource management, site readiness and onboarding
Knowledge management and retention
Cost management and cost reduction
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Front-line supportFirst line of response and incidents triage
Documentation and resolution of incidents
Functional escalation for difficult incidents
Active coordination of support teams
Day by day Ops, NC, CAPA and change
Support of manufacturing meetings
Non conformance investigation support
Driving corrective and preventive actions
Execution of all software changes
System administrationSecurity of systems, applications and data
Proactive event management
Execution of system changes
Lifecycle management
Automation Systems Validation (ASV)
Change pack review
Periodic review
Front Line SupportMulti-Platform
24/7
Daily Operations NC, CAPA and Change Control
System Administration
Automation Systems Validation (ASV)
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Our Service delivery offering
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This team successfully provided 24/7 support to our sites; configures, qualifies and maintains our systems and provided end user training and business solutions. We also use resources from Zenith for our capital projects portfolio, and we appreciate their ability to quickly flex up or down, depending on our project demands. In a business environment where new products are manufactured, this flexibility is hugely important to meet challenging project timelines.
Execution System Senior Manager,Leading Pharmaceutical Company
“ Managed Services+ 24/7 on call support
+ System network administration
+ Computer system validation
+ Access to global resources and knowledge
+ Rapid response to site requirements
+ Improved enterprise performance
Delivering performance and reliability for your Manufacturing IT Systems
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ChallengesAvailability of skilled resources and stretched teams
Recruiting the right level of people with Life Science expertise
Getting project support as and when you need it
Smart allocation of resources
Injecting knowledge into the business
Responding quickly to site requirements with minimal impact on production
Making business improvements and cost reductions
Measuring performance
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Establish, keep and refineZenith Technologies Managed Services efficiently manage our clients automation support and optimise the cost of ownership of their IT and Automation systems. This allows the line managers to focus efforts on their own customers and the overall business needs.
A proven business model since 2006, our clients experience reduced cost and increased reliability for their on-site systems. Offering flexible commercial models and a robust methodology to design and implement a service in partnership with the end user, the benefits of utilising this service are significant.
Zenith can operate the technical elements of your entire facility through our highly customised service level agreements. We supply teams of technical personnel to operate your systems to the highest standards where compliance and high availability are paramount.
Managed Service offeringThe full range of activities available under Zenith’s Managed Service programme is:
Automation / Digital / MES / IT production support (HMI, SCADA, DCS, PLC, QBMS)
Automation / IT systems administration
Automation / IT and I&C projects
Maintaining Automation / MES / IT systems in a validated state
I&C engineering
CAD services and engineering document control
Resource supply
Access to offshore engineering and data entry
24/7 on call
ITIL compliant support services
Incident management
Pay for use support
Central to the success of our Managed Service is a customer-centric partnership approach. Performance is measured by an agreed set of KPIs developed in consultation with the customer and congruent with the customer’s site imperatives. This contributes ultimately to the business’ strategic objectives.
Meeting your challengesGuaranteed supply of expert resources
Rapid response to site requirement and issues
Access to global resources and knowledge
Account and engineering management
Metric development through reporting
Business continuity and uptime
Batch optimisation and improved yield
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Managed Services
Zenith have delivered 40% cost reduction while improving service levels in the last 4 years. We are extremely satisfied with their managed services performance.
Execution System Senior Manager,Leading Pharmaceutical Company
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24/7 Manufacturing IT Services + 30% of all incidents resolved by the remote
front-line support team
+ Satisfy > 90% of the response time KPIs
+ Escalation to SMEs and the 900+ strong engineering pool
Your application lifeline keeping your systems running
ChallengesKeeping applications up and running
Managing system incidents
System knowledge and capabilities
Reducing incident response times
Flexible shift support when you need it
Making proactive business improvements
Sitting as part of Zenith’s managed services division, the 24/7 Manufacturing IT Service provides high quality multi-platform engineering support across Automation, MES and Quality Control Lab IT Systems. It offers a single point of contact with faster incident response and resolution times when manufacturing IT applications fail or are not running to their optimum capacity.
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ServicesThe service is designed for Life Science manufacturers and can be offered onsite, remotely or a combined approach to suit the customer shift support needs. It provides analytical support directly to the end customer, with queries routed to a hub of specialist engineer when required.
This full end to end 24/7 Manufacturing IT Service is managed centrally from Zenith’s UK office with global resources offering round-the-clock support. The service offers value to its customers by supporting entire business processes, providing high quality, multi-platform engineering support.
Having a single point of contact for all applications is a real advantage to our customers, who get access to the Zenith global resource hub for incident resolution and business improvement strategies.
This service enables our support analysts to be an application life line, delivering a complete service offering that goes beyond support.
This approach leads to faster incident response and resolution times with minimal impact on the batch.
Meeting your challengesProviding high quality multi-platform engineering (Automation, MES and Lab) Front Line Support
Single point of contact for all incidents regardless of their origin leading to faster response times
Objective 30% of all incidents resolved directly by the remote FLS team
Satisfy >90% of the response time KPIs
Increasing knowledge base to increase reliability and response times to incidents
Escalation to SMEs and the 900 strong engineering pool in Zenith Technologies
Cost effective solution
Reduces the number of people on site
Provides a scalable remote extension of their team without overheads
Creates a culture of proactivity
Reduces failure risks
Full end to end service, supporting the whole businesses process including equipment and hardware
Taking accountability for the end to end service process
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Professional Placement+ Skilled resource solutions
+ High level consultants at your fingertips
+ Support driven project deployment
+ Optimised resource utilisation
+ Knowledge transfer
+ Improved enterprise performance
ChallengesAvailability of skilled resources
Recruiting the right level of people
Finding people with specialised Life Science expertise
Stretched teams
On-demand project support
Smart allocation of resources
Injecting knowledge into the business
Life Science industries require the highest calibre of skilled resources to drive their business forward in terms of technology, business development and performance.
Zenith Technologies provides a comprehensive and tailored resource augmentation solution for companies that need specialist skills for particular projects or areas of their business.
Our resources are experts in Life Sciences, Automation, MES and Digital. We ensure that you are supplied with the correct level of resource to complement your business objectives, for the length of time that you require.
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Inject High Level Consultants in Life Sciences into Your Business
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ServicesZenith is unique in this sector for providing a specialist, dedicated and professional placement service at the disposal of its customer base. Customers can leverage their partnership with us to source highly skilled professionals.
Our workforce management service provides fast, flexible and cost-effective personnel solutions. Whether you require a resource in the short or long-term, as a contract or temporary member of your team, we can provide the right personnel to meet the changing needs of your business.
Zenith Professional Placement Services provides resources in the following areas:
Automation and control engineering
Project engineering and management
Commissioning and start-up
Project services and instrumentation engineering
Electrical engineering and process engineering
Validation and document control
System support
Production engineering
MES / MOM / MIS Systems
Zenith Technologies’ established Professional Placement service, delivers fast, flexible, and cost-effective personnel solutions to meet the changing needs of your business. Our offering covers both short- and long-term placements.
Meeting your challenges…We deliver the highest caliber of resources to directly meet your requirements
Giving access to senior life science professionals
Using smart allocation – the optimum resources delivered to drive results
Enabling future planning by professional engineers
Combating the skills shortage
Helping support teams and transfers knowledge
Empowering businesses to manage and improve performance in a cost-effective way
Contributing to lower total cost of ownership
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Commissioning, Qualification and Validation (CQV)+ Computer Systems Validation (CSV) programme delivery
+ Development of risk-based approaches to testing
+ Vigorous testing, validation and quality assurance
+ Facility start up and hyper care
+ Commissioning, Qualification and Validation (CQV) team support
Testing, validation and quality assurance guaranteed
Professional Placement
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Meeting your challengesThe CSV plan and execution ensures that the delivered manufacturing systems satisfy regulatory expectations. Zenith Technologies ensure that your software and systems are fit for intended use and satisfy the requirements for design, installation, operation and performance. Our approach integrates CSV with CQV and applies the concepts and principles outlined in:
FDA Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach
ASTM E2500 - 13 Standard Guide for Specification
Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
International Council for Harmonisation (ICH)* Framework
ISPE – GAMP 5 Guide: Compliant GxP Computerized Systems
* ICH Q8 (R2) Pharmaceutical development
ICH Q9 Quality risk management
ICH Q10 Pharmaceutical quality system
ICH Q11 Development and manufacture of drug substance
ChallengesImplementing a risk-based approach to the project lifecycle
Creating CSV plans that support commissioning plans
Resourcing FAT Teams
Executing Automation Test protocols to support CTPs
Supporting CQV teams with Automation & MES expertise
Change Control Execution
Cost & time taken for CSV
The true test of the success of Automation, MES and Quality Control (QC) Lab Software is when it arrives on site. Ensuring the Commissioning, Qualification and Validation (CQV) process runs smoothly is critical to project success and it is a journey that starts early in the project lifecycle with the Computer Systems Validation (CSV) plan.
ServicesThe full range of services available from Zenith’s CQV team is:
CSV TESTING AND SOFTWARE TEAMS
Creation of CSV Master Plan
Execution of the full risk management lifecycle including the execution of the risk assessments driving actions
Provision of site CSV teams with managed oversight and reporting
Provision of Factory Acceptance Testing (FAT) teams
Provision of Automation, MES and QC Lab IT resources to support CQV
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Commissioning, Qualification and Validation (CQV)
The Zenith Team helped us develop strategies to ensure compliance, whilst at the same time preparing us for submission to the FDA.
Automation and Control Director,Leading BioTech Company
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Planning Software Build & Testing PreparationDesign Acceptance Testing Delivery & Site Acceptance
Testing (DSAT)
Supplier Change Control
Client Installation
Client Change ControlProject Change Control
Delivering Qualified Software
Zenith CSV Activities Zenith/ Client CSV Activities
System Compliance Assessment (SCA)
CSV Master Plan Validation Summary Report
Operational Qualification (OQ) Test Environment
Installation Qualification (IQ) Production Environment
Installation Qualification (IQ) Test Environment
User Requirements Specification (URS)
Design Specification Inc. Configuration Requirements
Application Test Protocols
Commissioning Test Packs
Requirements Traceability Matrix (RTM)
Responds
Verifies
Verifies
Electronic RecordElectronic Signature Assessment21 CFR Part 11 Assessment (EREF)
Data Integrity Assessment (DIA)
System Compliance Assessment (SCA)
Electronic RecordElectronic Signature Assessment21 CFR Part 11 Assessment (EREF)
Requirements Traceability Matrix (RTM)
Data Integrity Assessment (DIA)
CSV Plan
Responds
Verifies
Verifies
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
Design Specification (DS)
Module Specification (MS)
Application Build Design Review 1
Design Review Risk Assessment
Design Review 2 (RTM)
Pre software delivery
Code Review
Internal Testing
Factory Acceptance Testing (FAT)
Validation Summary Report (VSR)
Client Site Installation (DSAT)
Test Summary Report (TSR)
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Learning and Capability Services + Identify skill gaps in your organisation
+ Preparing for upgrades, new lines or technology
+ Customised training based on your facility
+ Regulatory compliant training
+ Knowledge retention
+ Standardised training rolled out globally
+ Augmented Reality
ChallengesSkills shortages
Matching training time with production demands
Upskilling training operators quickly to run sophisticated facilities
To continuously build capability in the workforce
The operator not being trained on the actual system they will use
Finding a solution provider that offers customised training
Meeting compliance requirements
Boosting manufacturing performance
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EffectiveAppropriate Continuous
Graduate and young engineer training
Training programme designed to both develop talent and reduce costs
No headcount risk to you and time to select the perfect fit for your organisation
Developing an organisational learning capability based on the reflective action learning cycle
Targeted online learning modules
Online learning to reduce overall cost
Targeted training modules for use in GMP
Quality systems as NC actions
Meeting your challengesAt Zenith Technologies we take the headache out of sourcing the right learning solutions for Life Science industries. Using the latest instructional design and distance learning techniques, we provide focused and customised learning solutions.
Identify skill gaps within your organisation
Increase the competency levels of your teams
Access customised training for different roles or locations
Virtual training customised with the look and feel of your system
No license costs or installation
Deployment of custom training in a web browser
Ensure your teams are prepared for any changes in production / plant
Provide real world training in a safe environment
Ensure regulatory compliance is met
Deliver real-time updates, metrics and KPIs on individual and team progression
Align training requirements with production demands
Boost manufacturing performance
IntroductionZenith Technologies is a globally trusted provider of high quality online, classroom and blended learning solutions for customers in Life Science industries. Our training experts can create both generic and customised courses to suit every system training need.
Zenith is your training partner. Through our site service teams, we can develop and refresh your training to target your pain points, providing effective continuous learning. We are able to utilise assets from your customised training system to produce eLearning, delivering targeted training and simulated exercises on demand.
We will work with you to develop a learning path. to cover the journey from onboarding new starters, through to effective manufacturing associates. Continuously linking demonstrated capability to control system access level.
Services
Customised system training Deliver high quality customised instructor-led training focused on capability development
Training designed for key roles in your manufacturing organisation
Based on your system and operating practices
Captures capability building exercises and deploys them to standard business computers without installation
Expert trainingDelivering expert training to develop knowledge
Competency based training and education
Multiple platform technology training
Cross trainingDriving cross training to retain knowledge
Reducing resource single point of failure
Increasing the team effectiveness and flexibility
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Bridge the gap in your learning
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The customised online learning packages gave our people the skills, information and detailed reference material they needed to manage and operate the control system effectively. This helps us to maintain exceptional standards and ensure regulatory compliance.
Production Automation Manager,Leading Pharmaceutical Company
“Joe Haugh, CEO, Zenith Technologies
The Life Science industry is incredible, it’s a marvellous and exciting industry to be working in.
What our customers are doing really makes a difference to people, they’re making drugs that positively impact health the world over and the teams at Zenith are integral to the success of our partners.
Our Values
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Your Global Life Science PartnerPowering Patient Health