Good Automated Manufacturing Practice (GAMP 5 ®) - CSV
Pharmaceutical And Medical Device Software Validation
Good Automated Manufacturing Practice
(GAMP 5 ®) CSV
Pharmaceutical And Medical Device Software Validation
Good Automated Manufacturing Practice (GAMP 5 ®) CSV
Pharmaceutical And Medical Device Software Validation
GxP Computer System Validation Services
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Good Automated Manufacturing Practice
(GAMP 5 ®) CSV
Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality. GAMP 5 ® details a recognised standard for Computer System Validation (CSV).
GAMP 5 ® is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated or computer systems. Primarily intended for the pharmaceutical industry, GAMP 5 ® is also now being adopted as suitable guidance for the Medical Devices industry and other highly regulated industries.
One of the core principles of GAMP ® is that quality cannot be tested into a batch of product or device, but must be built into each stage of the manufacturing process.
As a result, GAMP ® covers all aspects of production; from the raw materials, facilities and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. Electronic Records and Electronic Signatures (ERES) are also covered in GAMP 5 ®.
Life Science Industry suppliers
should follow the spirit of
GAMP 5 ®.
Supplier Audits performed by a ZES Validation Consultant
ascertain the actual level of computer system best practice.
Good Automated Manufacturing Practice (GAMP 5 ®) CSV
Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality. GAMP 5 ® details a recognised standard for Computer System Validation (CSV).
GAMP 5 ® is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated or computer systems. Primarily intended for the pharmaceutical industry, GAMP 5 ® is also now being adopted as suitable guidance for the Medical Devices industry and other highly regulated industries.
One of the core principles of GAMP ® is that quality cannot be tested into a batch of product or device, but must be built into each stage of the manufacturing process.
As a result, GAMP ® covers all aspects of production; from the raw materials, facilities and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. Electronic Records and Electronic Signatures (ERES) are also covered in GAMP 5 ®.
Life Science Industry suppliers
should follow the spirit of GAMP 5 ®.
Supplier Audits performed by a ZES Validation Consultant ascertain the actual level of computer system best practice.
Good Automated Manufacturing Practice
(GAMP 5 ®) CSV
Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality. GAMP 5 ® details a recognised standard for Computer System Validation (CSV).
GAMP 5 ® is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated or computer systems. Primarily intended for the pharmaceutical industry, GAMP 5 ® is also now being adopted as suitable guidance for the Medical Devices industry and other highly regulated industries.
One of the core principles of GAMP ® is that quality cannot be tested into a batch of product or device, but must be built into each stage of the manufacturing process.
As a result, GAMP ® covers all aspects of production; from the raw materials, facilities and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. Electronic Records and Electronic Signatures (ERES) are also covered in GAMP 5 ®.
Life Science Industry suppliers
should follow the spirit of GAMP 5 ®.
Supplier Audits performed by a ZES Validation Consultant ascertain the actual level of computer system best practice.
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
GxP Computer System Validation (CSV) Services
To GAMP 5 ®
ZES Computer System Validation Services include full lifecycle documentation generation and protocol execution, incorporating:
- Cloud Systems
- Risk Assessments
- Software Validation
- Position Statements
- Serialisation for FMD
- Inventory Management
- Spreadsheet Validation
- Validation Gap Analysis
- Data Integrity Assessments
- Automated Systems (PLCs)
- Site Validation Master Plans
- Full Computer System Validation Lifecycle
- System Validation Plans to Summary Reports
- CSV Training Delivered by Industry Experts
- Validation Strategy Implementation Adopting a Risk-Based Approach
- Electronic Record and Electronic Signature Assessment and Remediation
Need CSV Help from an
Industry Expert?
ZES have experienced Validation Consultants ready to take your call.
GxP Computer System Validation (CSV) Services To GAMP 5 ®
ZES Computer System Validation Services include full lifecycle documentation generation and protocol execution, incorporating:
- Cloud Systems
- Risk Assessments
- Software Validation
- Position Statements
- Serialisation for FMD
- Inventory Management
- Spreadsheet Validation
- Validation Gap Analysis
- Data Integrity Assessments
- Automated Systems (PLCs)
- Site Validation Master Plans
- Full Computer System Validation Lifecycle
- System Validation Plans to Summary Reports
- CSV Training Delivered by Industry Experts
- Validation Strategy Implementation Adopting a Risk-Based Approach
- Electronic Record and Electronic Signature Assessment and Remediation
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Need CSV Help from an Industry Expert?
ZES have experienced Validation Consultants ready to take your call.
GxP Computer System Validation (CSV) Services To GAMP 5 ®
ZES Computer System Validation Services include full lifecycle documentation generation and protocol execution, incorporating:
- Cloud Systems
- Risk Assessments
- Software Validation
- Position Statements
- Serialisation for FMD
- Spreadsheet Validation
- Inventory Management
- Validation Gap Analysis
- Site Validation Master Plans
- Data Integrity Assessments
- Automated Systems (PLCs)
- Computer System Validation Lifecycle
- CSV Training Delivered by Industry Experts
- System Validation Plans to Summary Reports
- Validation Strategy Implementation adopting a Risk-Based Approach
- Electronic Record and Electronic Signature Assessment and Remediation
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Need CSV Help from an Industry Expert?
ZES have experienced Validation Consultants ready to take your call.
Medical Device Validation Performed By ZES
IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. GAMP 5 ® and IEC 62304 adopt similar approaches to achieve a compliant structure for software to safeguard patients.
If you have concerns about your current state of computer system validation, data integrity and the potential impact it could have on a patient, ZES can help.
Medical Device Validation Performed By ZES
IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. GAMP 5 ® and IEC 62304 adopt similar approaches to achieve a compliant structure for software to safeguard patients.
If you have concerns about your current state of computer system validation, data integrity and the potential impact it could have on a patient, ZES can help.
ZES Consultant GxP Computer System Experience
GMP Computer Systems ZES have worked on include, but are not limited to:
Business Process Management:
- Change Control
- ERP, MRP, MRP II
- Serialisation (FMD)
- Maintenance Management
- System Inventory Databases
- Preferred Supplier Databases
- Chromatography Data Systems
- Document Management (eDMS)
- Enterprise Resource Planning (ERP)
- Quality Management Systems (eQMS)
- Manufacturing Execution Systems (MES)
- Warehouse Management Systems (WMS)
- Customer Relationship Management (CRM)
- Laboratory Information Management (LIMS)
Facility Management Systems:
- IT Infrastructure
- Cloud-Based Systems
- Data Historian Systems
- Distributed Control Systems (DCS)
- Building Management Systems (BMS)
- Environmental Monitoring Systems (EMS)
- Supervisory Control and Data Acquisition Systems (SCADA)
| 800 xA | PAS-X | DeltaV | SAP S/4 HANA | SIMATIC STEP 7 |
| Net Suite | Dynamics | TrackWise | Salesforce | TREND | SEA Vision |
Validation Consultancy Services Delivered By An Experienced Consultant
ZES Consultant GxP Computer System Experience
GMP Computer Systems ZES have worked on include, but are not limited to:
Business Process Management:
- Change Control
- ERP, MRP, MRP II
- Serialisation (FMD)
- Maintenance Management
- System Inventory Databases
- Preferred Supplier Databases
- Chromatography Data Systems
- Document Management (eDMS)
- Enterprise Resource Planning (ERP)
- Quality Management Systems (eQMS)
- Manufacturing Execution Systems (MES)
- Warehouse Management Systems (WMS)
- Customer Relationship Management (CRM)
- Laboratory Information Management (LIMS)
Facility Management Systems:
- IT Infrastructure
- Cloud-Based Systems
- Data Historian Systems
- Distributed Control Systems (DCS)
- Building Management Systems (BMS)
- Environmental Monitoring Systems (EMS)
- Supervisory Control and Data Acquisition Systems (SCADA)
| 800 xA | PAS-X | DeltaV |
| SAP S/4 HANA |
| SIMATIC STEP 7 | Net Suite |
| Dynamics |
| Trackwise | Salesforce | TREND |
| SEA Vision |
ZES Consultant GxP Computer System Experience
GMP Computer Systems ZES have worked on include, but are not limited to:
Business Process Management:
- Change Control
- ERP, MRP, MRP II
- Serialisation (FMD)
- Maintenance Management
- System Inventory Databases
- Preferred Supplier Databases
- Chromatography Data Systems
- Document Management (eDMS)
- Enterprise Resource Planning (ERP)
- Quality Management Systems (eQMS)
- Manufacturing Execution Systems (MES)
- Warehouse Management Systems (WMS)
- Customer Relationship Management (CRM)
- Laboratory Information Management (LIMS)
Facility Management Systems:
- IT Infrastructure
- Cloud-Based Systems
- Data Historian Systems
- Distributed Control Systems (DCS)
- Building Management Systems (BMS)
- Environmental Monitoring Systems (EMS)
- Supervisory Control and Data Acquisition Systems (SCADA)
| 800 xA | PAS-X | DeltaV | SAP S/4 HANA | SIMATIC STEP 7 |
| Net Suite | Dynamics | TrackWise | Salesforce | TREND | SEA Vision |
GMP Pharma Production Systems:
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), Visualisation Systems, Bioreactors, Isolators, Robots etc
GMP Utility Systems:
HVAC, Nitrogen, Clean Steam, WFI, Purified Water, Compressed Air Systems.
GMP Facilities (Cleanrooms):
Various facilities, including sterile manufacturing. Greenfield and brownfield projects.
Spreadsheet Validation:
Spreadsheets covering every aspect of a Life Science Organisation's operation.
Medical Devices And IVDs:
Various Medical Devices | Class I | Class IIa | Class IIb | Class III |
Various complex devices such as infusion pumps to IEC 62304 60601 etc.
GMP Pharma Production Systems:
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), Visualisation Systems, Bioreactors, Isolators, Robots etc.
GMP Utility Systems:
HVAC, Nitrogen, Clean Steam, WFI, Purified Water, Compressed Air Systems.
GMP Facilities (Cleanrooms):
Various facilities, including sterile manufacturing. Greenfield and brownfield projects.
Spreadsheet Validation:
Spreadsheets covering every aspect of a Life Science Organisation's operation.
Medical Devices And IVDs:
Various Medical Devices | Class I | Class IIa | Class IIb | Class III |
Various complex devices such as infusion pumps to IEC 62304 60601 etc.
GMP Pharma Production Systems:
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), Visualisation Systems, Bioreactors, Isolators, Robots etc.
GMP Utility Systems:
HVAC, Nitrogen, Clean Steam, WFI, Purified Water, Compressed Air Systems.
GMP Facilities (Cleanrooms):
Various facilities, including sterile manufacturing. Greenfield and brownfield projects.
Spreadsheet Validation:
Spreadsheets covering every aspect of a Life Science Organisation's operation.
Medical Devices And IVDs:
Various Medical Devices | Class I | Class IIa | Class IIb | Class III |
Various complex devices such as infusion pumps to IEC 62304 60601 etc.
Testimonial
Pharmaceutical Manufacturing Facility: DCS CSV
"I worked with David [of Zener Engineering Services] on a project to deliver an ABB 800XA DCS system for a Blue Chip Pharmaceutical company. He was the QA lead for the supplier.
We jointly reviewed and approved a very large FAT document set in lieu of a reduced SAT and OQ. David's approach is very professional, critical, but crucially pragmatic.
I enjoyed working with him and would welcome any future opportunities to do so."
Steve Del-Bianco
Computer Systems Validation Analyst
GlaxoSmithKline GMS WARE
Computer System Validation Frequently Asked Questions
ZES answer your Computer System Validation questions.
-
What is Software Validation?
Software Validation is the process of evaluating software during the development process and or at the end of the development process to determine whether it satisfies specified business requirements. Testing ensures that the product actually meets the client's needs and is suitable for it's intended use.
-
What is Computer System Validation in Pharmaceuticals?
Computer System Validation (CSV) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines.
-
What is a Computer System?
A computer system is a complete, working computer.
Computer systems include the computer along with any software and peripheral devices that are necessary to make the computer function.
Every computer system, for example, requires an operating system. Most modern 'simple' systems contain a computer system of sorts.
Automated medical devices will contain a computer system, which needs to be validated.
-
What is GAMP 5?
GAMP® stands for Good Automated Manufacturing Practice.
GAMP®5, it is in reference to a guidance document entitled GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems
Do you have more questions?
Contact ZES
and we will be happy to help.
Computer System Validation Frequently Asked Questions
ZES answer your Computer System Validation questions.
-
What is Software Validation?
Software Validation is the process of evaluating software during the development process and or at the end of the development process to determine whether it satisfies specified business requirements. Testing ensures that the product actually meets the client's needs and is suitable for it's intended use.
-
What is Computer System Validation in Pharmaceuticals?
Computer System Validation (CSV) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines.
-
What is a Computer System?
A computer system is a complete, working computer.
Computer systems include the computer along with any software and peripheral devices that are necessary to make the computer function.
Every computer system, for example, requires an operating system. Most modern 'simple' systems contain a computer system of sorts.
Automated medical devices will contain a computer system, which needs to be validated.
-
What is GAMP 5 ® ?
GAMP ® stands for Good Automated Manufacturing Practice.
GAMP 5 ® it is in reference to a guidance document entitled GAMP5:® A Risk-Based Approach to Compliant GxP Computerized Systems
Do you have more questions? Contact ZES and we will be happy to help.
For all your Policies, SOPs and Protocol Templates
GxP Products For Sale
Visit our Products for Sale page for all your GxP CSV documentation templates.
For all your Policies, SOPs and Protocol Templates
GxP Products For Sale
Visit our Products for Sale page for all your GxP CSV documentation templates.
Need Help With 21 CFR Part 11?
Need Help With 21 CFR Part 11?
Data Integrity Guides For Download
MHRA’s GxP Data Integrity Guide 2018
Guidance for the UK
The GxP Data Integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.
MHRA’s GxP Data Integrity Guide 2018
Guidance for the UK
The GXP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.
FDA's Data Integrity And Compliance With Drug cGMP 2018
The FDA guidance aimed at helping drug manufacturers ensure data integrity and product safety. The document is an update to the FDA's 2016 draft guidance on the topic and will ensure industry compliance with current good manufacturing practice (cGMP).
If you need help implementing policies and procedure to achieve a good level of compliance, ZES experts are happy to help. Download the guidance here:
FDA's Data Integrity And Compliance With Drug cGMP 2018
The FDA guidance aimed at helping drug manufacturers ensure data integrity and product safety. The document is an update to the FDA's 2016 draft guidance on the topic and will ensure industry compliance with current good manufacturing practice (cGMP).
If you need help implementing policies and procedure to achieve a good level of compliance, ZES experts are happy to help. Download the guidance here:
Zener Engineering Services Ltd CSV
Need help with
GMP Computer Systems?
Need a GMP Automation
or Computer Engineer?
If you have concerns about your GxP computer systems and Data Integrity, ZES has helped many satisfied clients.
Contact ZES for expert help
with all aspects of CSV.
Zener Engineering Services Ltd CSV
Need help with GMP Computer Systems?
Need a GMP Automation or Computer Engineer?
If you have concerns about your GxP computer systems and Data Integrity,
ZES has helped many satisfied clients.
Contact ZES for expert help
with all aspects of CSV.
Zener Engineering Services Ltd - CSV
Need help with GMP Computer Systems?
Need a GMP Automation or Computer Engineer?
If you have concerns about your
GxP computer systems and Data Integrity,
ZES has helped many satisfied clients.
Contact ZES for expert help with all aspects of CSV.
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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