Validation
Computer System Validation (CSV) solutions for your pharmaceutical facility
Our validation solutions will help you maintain and prove compliance while also making compliance less costly and more efficient. Our validation support will also ensure your equipment, systems, and processes operate as expected and are suitable for their intended use.
Validation Solutions
Validation is an essential component of regulatory compliance. It can also be complex, costly, resource-intensive, and burdened with risks.
At Westbourne, we will simplify and streamline validation in your laboratory and wider pharmaceutical manufacturing operations. This will help ensure you remain in compliance while also reducing regulatory risks.
We will also reduce costs by making processes more efficient and less resource intensive.
Whether you have an immediate requirement, you want to improve processes in general, or both, our team has the expertise and experience that you need. Contact us today to arrange a consultation so we can get a better understanding of your needs.
How We Can Help
- Validating software installations, software configurations, and software upgrades, including LIMS (laboratory information management systems), CDS (chromatography data systems), SDMS (scientific data management systems), scientific instrument applications, MES (manufacturing execution systems), and more.
- Validating IT equipment installations and upgrades, including PCs and other IT equipment used in production environments and laboratories.
- Tailored to your requirements, from targeted support and specific projects to complete end-to-end outsourced solutions.
- Ensuring compliance with current standards, including 21 CFR Part 11, EU MDR Annex 11, and GAMP5.
- Validating laboratory and manufacturing equipment installations and upgrades.
- Digitalising manual and paper-based processes.
- Auditing documentation and processes to identify and rectify compliance breaches.
- Reviewing, creating, and updating validation master plans, templates, and SOPs (standard operating procedures).
- Validation training for your team.
Discuss Your Requirements
Benefits of Our Validation Solutions
- Ensure compliance and reduce compliance risks.
- Make processes more efficient through digitalisation, process optimisation, and automation. Moving to a risk-based approach by utilising CSA (computer software assurance) and GAMP5 best practices will deliver even greater efficiency savings.
- Enhance data integrity through standardisation and ensuring data accuracy, completeness, and availability.
- Avoid unnecessary delays.
- Ensure audit readiness.
- Establish systems and procedures that ensure future compliance processes are optimised.
- Reduce the cost of validation.
Validation Support Where You Need It
We provide on-site, remote, and hybrid validation solutions and can support your facility wherever it is in the world. Our expertise includes validating software, equipment, processes, and test methods.
Software Validation
With our extensive knowledge and experience of both CSV and CSA, we can validate all software applications used in your pharmaceutical laboratory and wider manufacturing facility. This includes bespoke applications, customised applications, and specialist software such as LIMS.
Our expertise includes design qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). This will ensure your applications remain in a validated and compliant state across their full lifecycle.
Utilising CSA and GAMP5 best practices, we’ll also implement a risk-based approach to minimise process steps and documentation requirements while ensuring you remain in full compliance.
Equipment Validation
We offer comprehensive support to validate equipment, covering all aspects of your operation, including IT equipment as well as laboratory equipment/instruments and manufacturing equipment. Our support covers the full equipment lifecycle, so includes IQ, OQ, and PQ services.
Process Validation
Our process validation solutions and support will ensure your pharmaceutical laboratory and manufacturing processes remain in compliance with GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice). Validation support is available across all three stages:
- Process design
- Process qualification
- Ongoing verification
Test Method Validation
Our team will assess the test methods used in your facility to ensure they are fit for purpose. We’ll identify any limitations and influences that exist so improvements can be made. We’ll also create all necessary test method validation documentation to ensure compliance and audit readiness.
Full Product Lifecycle Validation Support
Validation is a regulatory requirement across the entire product, system, process, and equipment lifecycle. At Westbourne, we offer full lifecycle support:
- Planning – requirement analysis and design
- Implementation – installation and testing
- Operation – monitoring and improving
- Retirement – migration and end-of-life
Throughout each product lifecycle stage, we’ll optimise design review processes, configuration management, traceability, document management, and risk management.
Arrange a Consultation
Validation doesn’t need to be a headache in your pharmaceutical facility, plus it can be less costly than it is today with a reduced burden on your quality resources. We can help by providing additional support to your team or completing a specific project, plus we offer fully outsourced services. Get in touch with us to find out more about our validation solutions.
Validation FAQs
Can you help identify validation shortcomings and issues?
Our process typically starts with an assessment where we analyse your current processes and documentation. From there we can make recommendations on the steps that should be taken to bring you up to full compliance. We'll also put in place processes, templates, and training to make it easier to maintain compliance in the future.
What is the difference between CSA and CSV?
In brief, CSA builds on traditional CSV processes. It shifts the focus away from documenting everything from scratch to an approach that is based on risks. This reduces the time involved in validating computer systems while also improving safety and quality. Documentation is still required, but there is a greater emphasis on computer systems that represent the highest risks to safety and quality.
Do you provide validation training?
Our validation engagements with pharmaceutical industry clients often involve a training element. This especially applies when we have created new or updated validation master plans, templates, and/or SOPs. All training will be tailored to your processes, workflows, and personnel.
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