Supplier Audits / Inspections
Zener Engineering Services Ltd
Supplier Audits / Inspections
Zener Engineering Services Ltd
Supplier Audits
Inspections
Zener Engineering Services Ltd
Need A GxP Supplier Audit?
Zener Engineering Services Ltd (ZES)
perform Supplier Audits / Inspections
on behalf of GxP clients, which are an important part of the GxP customer - supplier business relationship, aiming to check and improve the current quality and delivery processes.
Supplier Audits are an FDA, MHRA and EMA Regulatory Requirement, and also a requirement of the ISO9000 standards. Benefits of supplier audits performed by ZES include:
- Achieving regulatory compliance for the GxP customer.
- Ensuring Supplier Software coding practices are to the required standard.
- Ensuring the GxP Supplier has an established, functional and efficient Quality Management System (QMS).
- Ensuring the GxP Supplier has transparent documentation, of optimisation processes, assuring the quality of the supplied GxP product.
Would you like ZES to perform a GxP Supplier Audit?
ZES will be happy to help you.
Need A GxP Supplier Audit?
Zener Engineering Services Ltd (ZES)
perform Supplier Audits / Inspections
on behalf of GxP clients, which are an important part of the GxP customer - supplier business relationship, aiming to check and improve the current quality and delivery processes.
Supplier Audits are an FDA, MHRA and EMA Regulatory Requirement, and also a requirement of the ISO 9000 standards. Benefits of supplier audits performed by ZES include:
- Achieving regulatory compliance for the GxP customer.
- Ensuring Supplier Software coding practices are to the required standard.
- Ensuring the GxP Supplier has an established, functional and efficient Quality Management System (QMS).
- Ensuring the GxP Supplier has transparent documentation, of optimisation processes, assuring the quality of the supplied GxP product.
Would you like ZES
to perform a GxP Supplier Audit?
ZES will be happy to help you.
Need A GxP Supplier Audit?
Zener Engineering Services Ltd (ZES)
perform Supplier Audits / Inspections
on behalf of GxP clients, which are an important part of the GxP customer - supplier business relationship, aiming to check and improve the current quality and delivery processes.
Supplier Audits are an FDA, MHRA and EMA Regulatory Requirement, and also a requirement of the ISO 9000 standards. Benefits of supplier audits performed by ZES include:
- Achieving regulatory compliance for the GxP customer.
- Ensuring Supplier Software coding practices are to the required standard.
- Ensuring the GxP Supplier has an established, functional and efficient Quality Management System (QMS).
- Ensuring the GxP Supplier has transparent documentation, of optimisation processes, assuring the quality of the supplied GxP product.
Would you like ZES to perform a GxP Supplier Audit?
ZES will be happy to help you.
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Pharmaceutical And Medical Device cGMP Manufacture
Pharmaceutical and Medical Device manufacturers are subject to MHRA, FDA and EMA inspection, depending on their product market.
ZES have worked closely with former FDA, MHRA and TGA inspectors to ensure inspection success.
Also ZES have performed a number of supplier audits, on behalf of manufacturers, to ensure the quality and integrity of the service or product being supplied.
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Pharmaceutical And Medical Device cGMP Manufacture
Pharmaceutical and Medical Device manufacturers are subject to MHRA, FDA and EMA inspection, depending on their product market.
ZES have worked closely with former FDA, MHRA and TGA inspectors to ensure inspection success.
Also ZES have performed a number of supplier audits, on behalf of manufacturers, to ensure the quality and integrity of the service or product being supplied.
"ZES are superb in delivering
a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Pharmaceutical And Medical Device cGMP Manufacture
Pharmaceutical and Medical Device manufacturers are subject to MHRA, FDA and EMA inspection, depending on their product market.
ZES have worked closely with former FDA, MHRA and TGA inspectors to ensure inspection success.
Also ZES have performed a number of supplier audits, on behalf of manufacturers, to ensure the quality and integrity of the service or product being supplied.
NHS Estates And Facilities Statutory Compliance Audits
The NHS have a legal obligation to ensure their premises are compliant with statutory regulations.
The spirit of these regulations is to ensure NHS staff and visitors (including people with disabilities) are able to operate within a hospital building without detriment to their general well being and the hospital building environment does not compromise the quality of the service provided.
Statutory audits carried out by ZES aim to identify the extent to which NHS hospital facilities comply. ZES provide a single source solution for any NHS estates audit requirement.
NHS Estates And Facilities Statutory Compliance Audits
The NHS have a legal obligation to ensure their premises are compliant with statutory regulations.
The spirit of these regulations is to ensure NHS staff and visitors (including people with disabilities) are able to operate within a hospital building without detriment to their general well being and the hospital building environment does not compromise the quality of the service provided.
Statutory audits carried out by ZES aim to identify the extent to which NHS hospital facilities comply. ZES provide a single source solution for any NHS estates audit requirement.
NHS Estates And Facilities Statutory Compliance Audits
The NHS have a legal obligation to ensure their premises are compliant with statutory regulations.
The spirit of these regulations is to ensure NHS staff and visitors (including people with disabilities) are able to operate within a hospital building without detriment to their general well being and the hospital building environment does not compromise the quality of the service provided.
Statutory audits carried out by ZES aim to identify the extent to which NHS hospital facilities comply. ZES provide a single source solution for any NHS estates audit requirement.
Supplier Audits Performed By Zener Engineering Services Ltd
Possible Areas For Audit / Inspection Performed By ZES
ZES have performed a number of Audits or mock Inspections for clients. Once the audit / inspection requirements have been established, boundaries set and expectations detailed, ZES will work professionally and in a timely manner to provide a single source for any requirement. Possible areas include:
- Decontamination
- Best Practice (cGMP)
- HTM & HBN Compliance
- FDA \ MHRA \ EMA Compliance
- Manufacturing Compliance
- Water
- Plant Steam
- Quality Water
- Quality Steam
- Medical Gases
- Electrical Services
- Ventilation (HVAC)
- Design
- Lighting
- Surface Finish
- Fire Engineering
- Change Control
- Quality Management Systems
- Policies, Procedures, SOPs etc
- Validation
- PRINCE 2
- Permit to Work
- COSHH Regulations
- GAMP 5 ®
- Data Integrity
- Data Security
Possible Areas For Audit / Inspection Performed By ZES
ZES have performed a number of Audits or mock Inspections for clients. Once the audit / inspection requirements have been established, boundaries set and expectations detailed, ZES will work professionally and in a timely manner to provide a single source for any requirement. Possible areas include:
- Decontamination
- Best Practice (cGMP)
- HTM & HBN Compliance
- FDA \ MHRA \ EMA Compliance
- Manufacturing Compliance
- Water
- Plant Steam
- Quality Water
- Quality Steam
- Medical Gases
- Electrical Services
- Ventilation (HVAC)
- Design
- Lighting
- Surface Finish
- Fire Engineering
- Change Control
- Quality Management Systems
- Policies, Procedures, SOPs etc
- Validation
- PRINCE 2
- Permit to Work
- COSHH Regulations
- GAMP 5 ®
- Data Integrity
- Data Security
Possible Areas For Audit / Inspection Performed By ZES
ZES have performed a number of Audits or mock Inspections for clients. Once the audit / inspection requirements have been established, boundaries set and expectations detailed, ZES will work professionally and in a timely manner to provide a single source for any requirement. Possible areas include:
- Decontamination
- Best Practice (cGMP)
- HTM & HBN Compliance
- FDA \ MHRA \ EMA Compliance
- Manufacturing Compliance
- Water
- Plant Steam
- Quality Water
- Quality Steam
- Medical Gases
- Electrical Services
- Ventilation (HVAC)
- Design
- Lighting
- Surface Finish
- Fire Engineering
- Change Control
- Quality Management Systems
- Policies, Procedures, SOPs etc
- Validation
- PRINCE 2
- Permit to Work
- COSHH Regulations
- GAMP 5 ®
- Data Integrity
- Data Security
Testimonials From Various Satisfied GxP Clients
Testimonial
Data Integrity Audit: Improvements Identified
Following the submission of a 37-page Data Integrity Audit Report from ZES, the client provided feedback, part of which is quoted below:
"........ turns out that on a national level the BMS [Building Management System] has never been validated by [supplier organisation removed]. So we have opened up a can of worms for them! [Organisation removed] are arranging each centre in the country to validate it."
Confidential
COVID Treatment Provider
Testimonial
Data Integrity Audit: Improvements Identified
Following the submission of a 37-page Data Integrity Audit Report from ZES, the client provided feedback, part of which is quoted below:
"........ turns out that on a national level the BMS [Building Management System] has never been validated by [supplier organisation removed]. So we have opened up a can of worms for them! [Organisation removed] are arranging each centre in the country to validate it.."
Confidential
COVID Treatment Provider
Zener Engineering Services Ltd Supplier Audits
Would you like ZES to perform a Supplier Audit?
ZES will be happy to help you.
Zener Engineering Services Ltd Supplier Audits
Would you like ZES to perform
a Supplier Audit?
ZES will be happy to help you.
Zener
Engineering
Services Ltd
Supplier Audits
Would you like ZES to perform a Supplier Audit?
ZES will be happy to help you.
