Validation Consultant Services GAMP 5 ® Consultancy
Validation Consultant Services GAMP 5 ® Consultancy
Validation Consultant Services GAMP 5 ® Consultancy
Pharmaceutical Engineer Medical Device Engineer
Pharmaceutical Engineer | Medical Device Engineer
Pharmaceutical Engineer | Medical Device Engineer
Validation Consultancy Services Main Menu
Use the icons below to quickly navigate the ZES Validation Consultancy and Validation Services included on this page.
Validation Consultancy Services Main Menu
Use the icons below to quickly navigate the ZES Validation Consultancy and Validation Services included on this page.
Validation Consultancy Services Main Menu
Use the icons below to quickly navigate the ZES Validation Consultancy and Validation Services included on this page.
Validation Consultancy Services Provided By ZES
Validation Services provided by Zener Engineering Services Ltd (ZES) Validation Consultants,
performed on manufacturing and quality processes, ensure that test samples are an accurate representation of batch quality. ZES provide cost-effective, risk-based, Validation Consultancy
solutions by only utilising industry experts as a ZES Validation Consultant.
Manufacturing equipment, producing pharmaceutical or medical device products for patient use, must be validated for the intended patient use at all times. ZES Validation Services
can help to ensure a constant validated state, through the implementation of quality systems, such as change control.
Pharma Validation and Medical Device Validation
of direct and indirect manufacturing systems, are areas of ZES expertise. ZES consultants have successfully validated many GxP systems whilst adopting and implementing suitable risk-based approaches.
Note : The testing of finished products alone cannot ensure quality and safety for human consumption. Validation stems from the premise that Quality can’t be tested into the end product.
Whether you require an experienced GMP Pharmaceutical Engineer or Medical Device Engineer, ZES can provide the solution.
Our Validation Consultants are amongst
the most experienced in the industry.
Why not give ZES a call?
Validation Consultancy Services Provided By ZES
Validation Services provided by Zener Engineering Services Ltd (ZES) Validation Consultants,
performed on manufacturing and quality processes, ensure that test samples are an accurate representation of batch quality. ZES provide cost-effective, risk-based, Validation Consultancy
solutions by only utilising industry experts as a ZES Validation Consultant.
Manufacturing equipment, producing pharmaceutical or medical device products for patient use, must be validated for the intended patient use at all times. ZES Validation Services
can help to ensure a constant validated state, through the implementation of quality systems, such as change control.
Pharma Validation and Medical Device Validation
of direct and indirect manufacturing systems, are areas of ZES expertise. ZES consultants have successfully validated many GxP systems whilst adopting and implementing suitable risk-based approaches.
Note : The testing of finished products alone cannot ensure quality and safety for human consumption. Validation stems from the premise that Quality can’t be tested into the end product.
Whether you require an experienced GMP Pharmaceutical Engineer or Medical Device Engineer, ZES can provide the solution.
Our Validation Consultants
are amongst the most
experienced in the industry.
Why not give ZES a call?
Validation Consultancy Services Provided By ZES
Validation Services provided by Zener Engineering Services Ltd (ZES) Validation Consultants,
performed on manufacturing and quality processes, ensure that test samples are an accurate representation of batch quality. ZES provide cost-effective, risk-based, Validation Consultancy
solutions by only utilising industry experts as a ZES Validation Consultant.
Manufacturing equipment, producing pharmaceutical or medical device products for patient use, must be validated for the intended patient use at all times. ZES Validation Services
can help to ensure a constant validated state, through the implementation of quality systems, such as change control.
Pharma Validation and Medical Device Validation
of direct and indirect manufacturing systems, are areas of ZES expertise. ZES consultants have successfully validated many GxP systems whilst adopting and implementing suitable risk-based approaches.
Note : The testing of finished products alone cannot ensure quality and safety for human consumption. Validation stems from the premise that Quality can’t be tested into the end product.
Whether you require an experienced GMP Pharmaceutical Engineer or Medical Device Engineer, ZES can provide the solution.
Our Validation Consultants are amongst the most experienced in the industry.
Why not give ZES a call?
ZES GxP Engineering Validation Consultancy Services
ZES have significant experience of, and expertise in, the following Pharmaceutical and Medical Device quality engineering manufacturing aspects:
- Distribution and Supply
- Medical Device Validation
- Technology and Microbiology
- Safety Health and Environment
- Quality Assurance and Regulatory Issues
- Facility Design, Construction and Finishes
- Solid Dosage Forms (e.g. Powder / Tablets)
- Liquid Products, Parenterals and Sterilisation
- Services and Utilities - Steam, Water and Gases
- Environmental Systems – HVAC, Effluent and Containment
- ISO 13485
- Medical Device Software
- Packaging - Design and Operation
- All classes of Medical Device manufacturing
- Manufacturing Operations and Improvement
- Plant Utilities, Process and Computer Systems
- Process Control, Automation and Data Management
- 510k Submissions : ISO 60601 : CE Marking : IEC 62304 : Technical Files etc
- ZES Director David Easton is a former Chair of the IHEEM Medical Device Technical Platform
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
ZES GxP Engineering Validation Consultancy Services
ZES have significant experience of, and expertise in, the following Pharmaceutical and Medical Device quality engineering manufacturing aspects:
- ISO 13485
- Distribution and Supply
- Medical Device Software
- Medical Device Validation
- Technology and Microbiology
- Packaging - Design and Operation
- Safety Health and Environment
- Quality Assurance and Regulatory Issues
- Services and Utilities - Steam, Water and Gases
- Solid Dosage Forms (e.g. Powder / Tablets)
- Facility Design, Construction and Finishes
- Plant Utilities, Process and Computer Systems
- Liquid Products, Parenterals and Sterilisation
- Manufacturing Operations and Improvement
- Process Control, Automation and Data Management
- All classes of Medical Device manufacturing
- Environmental Systems – HVAC, Effluent and Containment
- 510k Submissions : ISO 60601 : CE Marking : IEC 62304 : Technical Files etc
- ZES Director David Easton is a former Chair of the IHEEM Medical Device Technical Platform
Validation Consultancy Services Delivered By An Experienced Consultant
ZES GxP Engineering Validation Consultancy Services
ZES have significant experience of, and expertise in, the following Pharmaceutical and Medical Device quality engineering manufacturing aspects:
- Distribution and Supply
- Medical Device Validation
- Technology and Microbiology
- Safety Health and Environment
- Quality Assurance and Regulatory Issues
- Facility Design, Construction and Finishes
- Solid Dosage Forms (e.g. Powder / Tablets)
- Liquid Products, Parenterals and Sterilisation
- Services and Utilities - Steam, Water and Gases
- Environmental Systems – HVAC, Effluent and Containment
- ISO 13485
- Medical Device Software
- Packaging - Design and Operation
- All classes of Medical Device manufacturing
- Manufacturing Operations and Improvement
- Plant Utilities, Process and Computer Systems
- Process Control, Automation and Data Management
- 510k Submissions : ISO 60601 : CE Marking : IEC 62304 : Technical Files etc
- ZES Director David Easton is a former Chair of the IHEEM Medical Device Technical Platform
Validation Life Cycle Services By ZES
Investment in the validation of equipment by ZES allow Pharmaceutical, Medical Device Manufacturers and Healthcare Service Providers to increase effectiveness by ensuring good engineering practices are being followed and documented. This in turn increases the degree of quality assurance in manufacturing systems. Our validation life cycle services for all systems and equipment include, but are not limited to:
- Equipment Validation
- Cold Chain Validation
- Risk-Based Approaches
- Medical Device Validation
- Gap Analysis and Remediation
- Commissioning and Qualification
- Test Protocol Writing and Execution
- Full Documentation Packages and Reports
- Reports and Requirement Traceability Matrix
- Concurrent, Prospective and Retrospective Validation
- Cleaning Validation
- Software Validation
- Spreadsheet Validation
- Maintenance Databases
- Drawing Updates and all CAD requirements
- Thermal Mapping using Kaye Validators
- Electronic Signatures and Records / Data Integrity
- Automation and Computer System Validation to GAMP 5 ®
Validation Life Cycle Services
- Equipment Validation
- Cold Chain Validation
- Risk-Based Approaches
- Medical Device Validation
- Gap Analysis and Remediation
- Commissioning and Qualification
- Test Protocol Writing and Execution
- Full Documentation Packages and Reports
- Reports and Requirement Traceability Matrix
- Concurrent, Prospective and Retrospective Validation
- Cleaning Validation
- Software Validation
- Spreadsheet Validation
- Maintenance Databases
- Drawing Updates and all CAD requirements
- Thermal Mapping using Kaye Validators
- Electronic Signatures and Records / Data Integrity
- Automation and Computer System Validation to GAMP 5 ®
Validation Life Cycle Services
- Equipment Validation
- Cold Chain Validation
- Medical Device Validation
- Commissioning and Qualification
- Test Protocol Writing and Execution
- Reports and Requirement Traceability Matrix
- Full Documentation Packages and Reports
- Gap Analysis and Remediation
- Risk-Based Approaches
- Concurrent, Prospective and Retrospective Validation
- Software Validation
- Cleaning Validation
- Spreadsheet Validation
- Maintenance Databases
- Thermal Mapping using Kaye Validators
- Drawing Updates and all CAD requirements
- Electronic Signatures and Records / Data Integrity
- Automation and Computer System Validation to GAMP 5 ®
"ZES are superb in delivering
a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Manufacturing Equipment ZES Have Experience With:
GMP Manufacturing Equipment ZES have extensive experience with include, but is not limited to, the following Pharma and Medical Device manufacturing systems:
GMP Production Systems And Manufacturing Equipment:
Blending, Mixing, Transfer, Weighing, Tableting, Capsule Filling, Vial Filling, Fluid Bed Dryin, Microwave Drying, Sterilisation Systems, CIP, SIP, Depyrogenation, Form Fill Seal, Leak Detection, Freeze Drying, Packaging, Labelling, Dispensing, Label Management Systems, Serialisation Systems (FMD), Bioreactors, Isolators, Robots etc
GMP Utility Systems:
GMP Facilities (Cleanroom Grades A - D):
A Range Of Medical Devices Including:
Various Medical Devices | Class I | Class IIa | Class IIb | Class III |
Various complex devices such as infusion pumps to IEC 62304 60601 etc
Manufacturing Equipment ZES Have Experience With:
GMP Manufacturing Equipment ZES have extensive experience with include, but is not limited to, the following Pharma and Medical Device manufacturing systems:
GMP Production Systems And Manufacturing Equipment:
Blending, Mixing, Transfer, Weighing, Tableting, Capsule Filling, Vial Filling, Fluid Bed Dryin, Microwave Drying, Sterilisation Systems, CIP, SIP, Depyrogenation, Form Fill Seal, Leak Detection, Freeze Drying, Packaging, Labelling, Dispensing, Label Management Systems, Serialisation Systems (FMD), Bioreactors, Isolators, Robots etc
GMP Utility Systems:
GMP Facilities (Cleanroom Grades A - D):
A Range Of Medical Devices Including:
| Class I | Class IIa | Class IIb | Class III |
Various complex devices such as infusion pumps to IEC 62304 60601 etc
| Bosch | Marchesini | Fedegari |
| Finn Aqua | Becomix | SEA Vision |
| Sartorius |
Manufacturing Equipment ZES Have Experience With:
GMP Manufacturing Equipment ZES have extensive experience with include, but is not limited to, the following Pharma and Medical Device manufacturing systems:
GMP Production Systems And Manufacturing Equipment:
Blending, Mixing, Transfer, Weighing, Tableting, Capsule Filling, Vial Filling, Fluid Bed Drying, Microwave Drying, Sterilisation Systems, CIP, SIP, Depyrogenation, Form Fill Seal, Leak Detection, Freeze Drying, Packaging, Labelling, Dispensing, Label Management Systems, Serialisation Systems (FMD), Bioreactors, Isolators, Robots etc
GMP Utility Systems:
HVAC, Nitrogen, Clean Steam, WFI, Purified Water, Compressed Air Systems
GMP Facilities (Cleanroom Grades A - D):
Various facilities, including sterile manufacturing. Greenfield and brownfield projects.
A Range Of Medical Devices Including:
Various Medical Devices | Class I | Class IIa | Class IIb | Class III |
Various complex devices such as infusion pumps to IEC 62304 60601 etc
| Bosch | Marchesini | Fedegari | Finn Aqua | Becomix | SEA Vision | Sartorius |
Benefits Of Validation Performed By ZES
The realised benefits of the validation services provided by ZES have been recognised by our clients all over Europe. ZES have enabled clients to realise benefits for all stages of the GMP manufacturing process, from raw materials to the distribution of finished product. Such benefits of the first class validation exercises performed by ZES include:
- Providing value for money and controlling costs
- Improving the deviation investigation process
- Manufacturing the product inline with the required specification
- Providing data to streamline manufacturing and business processes
- Identifying worst cases and risks to product quality, GMP and the business
- Achieving regulatory compliance, and reducing the risk of a non-compliance
- Increasing the degree of Quality Assurance in the manufacturing operation
- Increasing effectiveness by ensuring good engineering practices are being followed and documented
Adopting a risk-based approach to identify, assess and document the associated risks to product quality, will enable the manufacturing operation qualification and validation processes to be streamlined.
A direct benefit of a risk-based approach to validation, is that it provides tools to make informed decisions about where, why and to what degree the validation effort should be focused. A well documented Risk Assessment supported by sound rationale, will provide justifications for the decisions being made by the manufacturer, during an inspection.
Need help with Pharma Validation or MD Validation?
| Bosch | Marchesini | Fedegari | Finn Aqua | Becomix | SEA Vision | Sartorius |
Benefits Of Validation Performed By ZES
The realised benefits of the validation services provided by ZES have been recognised by our clients all over Europe. ZES have enabled clients to realise benefits for all stages of the GMP manufacturing process, from raw materials to the distribution of finished product. Such benefits of the first class validation exercises performed by ZES include:
- Improving the deviation investigation process
- Providing value for money and controlling costs
- Manufacturing the product inline with the required specification
- Providing data to streamline manufacturing and business processes
- Increasing the degree of Quality Assurance in the manufacturing operation
- Identifying worst cases and risks to product quality, GMP and the business
- Achieving regulatory compliance, and reducing the risk of a non-compliance
- Increasing effectiveness by ensuring good engineering practices are being followed and documented
Adopting a risk-based approach to identify, assess and document the associated risks to product quality, will enable the manufacturing operation qualification and validation processes to be streamlined.
A direct benefit of a risk-based approach to validation, is that it provides tools to make informed decisions about where, why and to what degree the validation effort should be focused. A well documented Risk Assessment supported by sound rationale, will provide justifications for the decisions being made by the manufacturer, during an inspection.
Need help with Pharma Validation or MD Validation?
Benefits Of Validation Performed By ZES
The realised benefits of the validation services provided by ZES have been recognised by our clients all over Europe. ZES have enabled clients to realise benefits for all stages of the GMP manufacturing process, from raw materials to the distribution of finished product. Such benefits of the first class validation exercises performed by ZES include:
- Improving the deviation investigation process
- Providing value for money and controlling costs
- Manufacturing the product inline with the required specification
- Providing data to streamline manufacturing and business processes
- Increasing the degree of Quality Assurance in the manufacturing operation
- Identifying worst cases and risks to product quality, GMP and the business
- Achieving regulatory compliance, and reducing the risk of a non-compliance
- Increasing effectiveness by ensuring good engineering practices are being followed and documented
Adopting a risk-based approach to identify, assess and document the associated risks to product quality, will enable the manufacturing operation qualification and validation processes to be streamlined.
A direct benefit of a risk-based approach to validation, is that it provides tools to make informed decisions about where, why and to what degree the validation effort should be focused. A well documented Risk Assessment supported by sound rationale, will provide justifications for the decisions being made by the manufacturer, during an inspection.
Need help with Pharma Validation or MD Validation?
Validation Frequently Asked Questions
Zener Engineering Services Ltd answer your Validation questions.
-
What are Validation Services?
Validation Services are independent procedures performed to check that a product, service, or system, meets documented requirements and specifications. They help assure that a product, service or system is suitable for its intended use.
-
Why is Validation Needed?
Validation ensures the quality of manufactured products and helps during the manufacturing process of quality products.
-
What are the Types of Validation?
There are 3 main types of validation:
- Prospective Validation.
- Concurrent Validation.
- Revalidation (Periodic and After Change)
Validation Frequently Asked Questions
ZES answer your Validation questions.
-
What are Validation Services?
Validation Services are independent procedures performed to check that a product, service, or system, meets documented requirements and specifications. They help assure that a product, service or system is suitable for its intended use.
-
Why is Validation Needed?
Validation ensures the quality of manufactured products and helps during the manufacturing process of quality products.
-
What are the Types of Validation?
There are 3 main types of validation:
- Prospective Validation.
- Concurrent Validation.
- Revalidation (Periodic and After Change)
Don’t just take our word for it...
New Medical Device Facility: Site Validation
"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)
During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.
...... ZES showed considerable knowledge on engineering and validation."
QC/RA Specialist
BD Medical
Don’t just take our word for it...
Pharma Manufacturing: Site Revalidation Project
"I briefly worked with David of Zener Engineering Services, when he was engaged as a validation manager.
David is an accomplished validation engineer and works to a high standard expected within the regulated environment.
I would have no hesitation in recommending him to anyone seeking a highly experienced engineering professional who knows his subject matter very well."
Bashir Hansraj - Technical Director
Aesica Pharmaceuticals Ltd
Zener Engineering Services Ltd
Validation Consultancy
Validation Consultancy
ZES are experts in helping clients
Give ZES a call for all your GxP engineering compliance needs.
Zener Engineering Services Ltd
Validation Consultancy
requirements,
ZES are experts in helping clients achieve their goals.
Give ZES a call for all your GxP engineering compliance needs
Zener Engineering Services Ltd
Validation Consultancy
Whatever your validation requirements,
ZES are experts in helping clients achieve their goals.
Give ZES a call for all your GxP engineering compliance needs.
Registered Office:
Rutherford House,
Warrington Road,
Birchwood,
Warrington, WA3 6ZH
United Kingdom.
Regional Office:
NETPark Plexus 2,
Thomas Wright Way,
Sedgefield, TS21 3FD
United Kingdom.
Contact Us:
Tel: (+44) 0843 5236 320 (Industry)
Tel: (+44) 0843 5236 325 (NHS)
Calls Cost 7p per min
Registered Office:
Rutherford House,
Warrington Road,
Birchwood,
Warrington,
England, WA3 6ZH
United Kingdom.
Regional Office:
NETPark Plexus 2,
Thomas Wright Way, Sedgefield, TS21 3FD
United Kingdom.
Contact Us
Tel: (+44) 0843 5236 320 (Industry)
Tel: (+44) 0843 5236 325 (NHS)
Calls Cost 7p per min
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