VALIDATION CONSULTING SERVICES

At BPV, validation is our niche. Our Subject Matter Experts (SMEs) have unparalleled knowledge and experience in providing validation consulting services, setting us apart from other firms, such as recruiters or agencies.

Whether you require assistance with validation master plans, validation protocols, or any other aspect of the validation process, our team is ready to help your company achieve its goals while maintaining regulatory compliance.

Our validation consulting services extend beyond VMPs and protocol development. We offer project management support, from project initiation to production, validation planning, remediation, and optimisation, as well as deviation management and closure. Our consultants are well-versed in validation methods and processes according to regulatory requirements, ensuring that our clients’ operations are fully compliant.

BPV offers comprehensive Validation Consulting Services to help life sciences companies navigate the complex process of equipment and system validation. Our team of Subject Matter Experts has extensive knowledge and experience in providing Validation Master Plans (VMPs), computer systems validation, equipment qualifications, process validation, and test method validation services.

At the core of our Validation Consulting services is the development of robust Validation Master Plans (VMPs) and validation protocols. BPV has its own validation protocols and clients can follow our cGMP-compliant documentation or can choose to use their own. Our consultants work closely with clients to understand their specific requirements and develop tailored VMPs that outline the planned validation activities, essential documents, staff responsibilities, and a documented approach for conducting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in compliance with cGMP requirements.

The VMPs created by our validation consultants employ risk analysis to establish the scope and extent of qualification protocols, applicable test methods, critical control points requiring evaluation, sampling locations, frequency, and size, as well as schedules for requalification. Key documents included in the VMPs are user requirement specifications, impact assessments, risk analyses, traceability matrices, qualification plans and reports, deviation reports, and final reports.

In addition to Validation Master Plan services, BPV offers assistance with validation throughout the entire lifecycle of equipment and systems. Our full validation package can be customised to suit client needs and typically includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Equipment Specific Development Testing, and Requalification packages.

Validation consultancy provides organisations with professional expertise and guidance and support, especially in highly regulated industries, helping them to manufacture high quality products whilst also meeting the relevant regulatory standards and industry best practices for the validation process.

Validation consultancy services typically cover all stages of the validation process, from process validation and equipment validation to cleaning validation, method validation, and computer system validation.

To take advantage of our team’s expertise in validation consultancy, reach out to us today to discuss your needs or request a quote.

Regulatory Compliance

Validation consultancy ensures your systems, processes, and equipment all comply with every relevant UK and international regulatory requirement.

Quality and Safety

Validation ensures your processes are consistent and repeatable and lead to the production of high quality, safe, and effective products.

Cost Effectiveness

By preventing compliance failures and recalls, validation consultancy ultimately helps your business to time and money in the long term.

Expert Guidance

Validation consultancy gives you access to specialised expertise and best practices, helping you to navigate complex validation processes with confidence.

At BPV, validation is our niche. Our Subject Matter Experts (SMEs) have unparalleled knowledge and experience in providing validation consulting services, setting us apart from recruiters or agencies. Whether you require assistance with validation master plans, validation protocols, or any other aspect of the validation process, our team is ready to help your company achieve its goals while maintaining regulatory compliance.

Our validation consulting services extend beyond VMPs and protocol development: we can also offer support with gap analysis, project management, validation planning, remediation, process optimisation, deviation management, project closure, and more.

BPV offers comprehensive validation consulting services to help life sciences companies navigate the complex process of equipment and system validation. We provide validation consultancy services to a wide range of business types, including the following.

Bio Products Validation Ltd (BPV) was established to offer the best level of validation services within the UK and Ireland life science industry. With a dedicated team of validation engineers and consultants, BPV’s team has provided services to the life science industry since 2005.

As a company, our engineers have over 100 years of combined experience working on a variety of validation projects, small and large, across the pharmaceutical and life science sectors. We understand that every company’s needs are different, so we will work with you to achieve your desired goals and outcomes efficiently.

Our experienced validation engineers can reduce your project timelines and overall costs by streamlining your processes and we can quickly scale our resources to meet your changing demands. BPV is a trusted name in the industry; our team is fully versed in cGMP and GxP regulations and boasts an unwavering commitment to excellence and customer satisfaction which truly sets us apart.