Delivering Excellence in Automation, MES and Digital ...€¦ · Validation (CQV) services. Vigorous testing, validation and quality assurance Facility start up and hyper care activities

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:


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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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


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


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


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


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)


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


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


[email protected]

Your Global Life Science PartnerPowering Patient Health

Documents

Delivering Excellence in Automation, MES and Digital ...€¦ · Validation (CQV) services. Vigorous testing, validation and quality assurance Facility start up and hyper care activities