Qualification
ISL offers a wide range of solutions that satisfy industry standards for equipment qualification. The engineering and science professionals at ISL are experienced in GMP requirements as well as industry practices. Our approach is built upon a strong technical understanding of the equipment being qualified and our applied expertise to achieve the most viable solution for each validation. Whenever practical, ISL employs a risk-based approach to equipment qualification and can use this technique to reduce costs and time to completion.
ISL works closely with your team to write qualifications that ensure equipment is designed and installed according to your process requirements. We are proficient at writing and executing operational qualifications that confirm and challenge established tolerances. Our team has applied experience that is well suited for developing and conducting performance qualifications to demonstrate that equipment functions consistently and meets process demands.
Validation is necessary to satisfy the requirements of governance documentation, but a strong validation program can do much more. Improvements to process efficiency and lower costs can be achieved by optimizing your equipment and production processes. To get the most out of these techniques and stay compliant, you need proven strategies for your validation program.
Our team is experienced in developing and executing a range of qualification [documentation] and our approach can be applied to any piece of equipment or type of instrument as indicated in [our achievements] and furthermore, our approach can be adjusted to suit any variety of industries.
Validation
There are many interpretations of process validation, but industry experts agree that it should be the final step in the product and/or process development cycle that ensures production is accurate and consistent over time. In fact, a failed process validation is often the result of incomplete or inadequate process development and testing. The engineering and science professionals at ISL understand the relationship of equipment, materials, facilities, computer systems and people that make up a successful process. Through careful design and detailed analysis, ISL can help your organisation validate the processes critical to your operation to ensure each operates within specifications and complies with the required guidelines and regulations.
The ISL team has experience in the development and execution of validation studies that demonstrate process performance and consistency. Our experts are knowledgeable in many areas including process analytical technology (PAT), enterprise data management and new software platforms that can be employed to meet your specific goals.
Drug manufacturers increasingly rely on automation, yet inadequate validation of control systems is still one of the most common sources of FDA 483 findings. Ensuring data integrity and security according to 21 CFR Part 11 is also an area of scrutiny for FDA auditors. ISL's proven risk-based approach to validating computer systems emphasises the most critical functions while ensuring the entire system is under control.
The engineering professionals at ISL are well versed in the relevant industry standards. ISL can provide the correct level of expert resource to validate any size system from a single PLC up to large DCS systems.
ISL works closely with your team to ensure that automation control systems are designed and installed according to your process requirements. We are proficient at developing and conducting risk assessments that result in complete Functional Requirements Specifications (FS) and test protocols that challenge established tolerances. Our team has applied experience that is well suited to helping you establish a validated state for your process control system.
Our team can help you validate both new and in-service PLCs, HMIs, networks, enterprise platforms, MES and other systems through the development and execution of validation [documentation] and our approach can be applied to any piece of equipment or type of instrument as indicated in [our achievements] and furthermore suited to any variety of industries.
Qualification / Validation Documentation
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Automation
Our automation system validation experience includes hardware and software from:
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Software validation and 21 CFR Part 11 are some of the most important issues facing companies today. ISL’s proven risk-based approach to validating computer systems and software emphasizes the most critical functions while ensuring the entire system is under control. This technique meets GAMP5 requirements and has been applied many times with great success. The engineering and science professionals at ISL are well versed in GAMP, Part 11, and industry practices and can help you validate both new and in-service computer systems, software and networks. Although not necessarily required for every project, our team is experienced in developing and executing:
Enterprise Resource Programs (ERP)
Manufacturing Enterprise Systems (MES)
Laboratory Information Management Systems (LIMS)
Data acquisition and processing systems
Chromatography software
Enterprise Workstations
Recent increases in drug potencies, patient sensitivity and harmful failures have led cleaning processes to receive extensive scrutiny from the authorities. The importance of cleaning verification and validation is made even more important when it isn’t feasible to use dedicated equipment for a given process or product. ISL can help with any size requirement, from providing associates to perform routine tests to developing a comprehensive cleaning validation program.
Engineering
ISL provides a wide range of automation services to our clients - from technical support to turn-key solutions encompassing automation / control systems engineering, consulting, training, commissioning and start-up. Our team is experienced with both process and discrete controls from a variety of DCS, PLC, and HMI vendors including ESD/SIS systems. We work closely with your team right from the start to ensure the scope and expectations of the project are well understood. Our goal is to be your first choice for automation support.
ISL engineers are experienced in GMP validation requirements and can save you time and money by adequately addressing these issues during the design, integration and support of automation / control system projects. Our engineering experts are very knowledgeable in many areas of industry including process analytical technology (PAT), vision systems, enterprise data management and new software platforms. Let us help you realise lower operating costs by improving process efficiency and optimizing your equipment.
ISL provides process engineering services that comply with MHRA, EMEA & FDA requirements for design, control and validation. We are familiar with a wide array of chemical and biological processes and can assist with many plant requirements – from facilities and purified water systems to process optimization and safety management. Our team of engineers has the technical and regulatory expertise to provide exactly what you need and we work closely with your team right from the start to ensure the scope and expectations of the project are well understood. Whether it’s a few hours consulting or a complete process design project, we can provide the help you need.
Regulatory
ISL understands Good Manufacturing Practices. Our experts specialise in delivering specifically to the needs of your company and industry, whether its pharmaceuticals, biotechnology or medical devices, our experts will work closely with you to help make the right decisions in the following areas:
Good Manufacturing Practices (GMP)
Process Validation
Systems Validation
Computer Systems Validation
Cleaning Validation
Equipment Commissioning and Qualification
Facility and Utility Qualification
Quality systems for manufacturing and laboratory operations are easily overlooked in small to medium sized companies. Effective programs for calibration, validation and maintenance are not established overnight and require vigilance to ensure consistent compliance. To help you avoid getting side tracked by growth or change, ISL can provide third party audits to identify compliance issues before the regulatory authorities or a customer does. Our experts help ensure that you're meeting the requirements of your quality system or see how far you need to go to meet it.
Our quality experts can inspect complete facilities or specific areas to provide an objective analysis of GMP compliance. We can inspect:
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Our team of experts can develop validation master plans or quality plans that layout the path for compliance. This step is highly recommended for large and small validation and quality improvement projects. It can also help address non-conformances or 483 findings by documenting clear objectives and accomplishments as you work towards compliance. Our experts understand GMP requirements and can provide specific or comprehensive assistance in a variety of areas.
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Off-site Services
ISL can offer all a range of services off-site.
Certain services can be carried out off-site dependant upon supply of information and complexity of the project and subject to briefing sessions. This can be appealing to small organisations for less complex projects.
Administrative responsibilities
Checking specification against vendor documentations
Generating protocols & plans
Developing & executing audit programs