COMPUTER SYSTEMS VALIDATION (CSV) SERVICES

Computer systems validation (CSV) is a documented process that ensure computerised systems consistently produce the intended results and meet pre-defined specifications. It primarily occurs in regulated industries such as pharmaceuticals, healthcare, and life sciences.

BPV provides comprehensive and scalable services to clients that encompass the entire computer systems validation lifecycle, from concept and defining requirements through to design, development, testing and implementation.

Our team of experts is dedicated to ensuring that your systems comply with all regulatory requirements and industry standards.

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

Computer Systems Validation (CSV) is a critical process in regulated industries such as pharmaceuticals, biotechnology, and medical devices. It ensures that software and computer systems used in GMP/GxP environments operate as intended and comply with regulations including FDA 21 CFR Part 11, EU Annex 11, and industry standards such as GAMP 5.

However, effective CSV delivers additional benefits beyond compliance. Most notably, when validation is built into projects from the outset, systems are implemented right first time, reducing rework, delays, and associated costs.

As a result, validated systems perform consistently from the beginning, ensuring data integrity and supporting strong performance.

Our professional focus on GxP compliance and technical validation expertise can be a significant asset, particularly for GMP facilities that are scaling up or upgrading their digital infrastructure.

In GMP-regulated environments, any computerised system that has the potential to impact product quality, patient safety, or data integrity must be validated. This could include any of the following:

• Laboratory systems
  • LIMS
• Production process equipment systems
• Manufacturing systems
  • MES
  • Facility Management Systems
  • Environmental Monitoring Systems
  • Visual Management Systems
  • PLC and HMI control systems
  • SCADA

• Quality systems
  • Regulatory Information Management Systems
• Electronic quality management systems (eQMS)
• Enterprise resource planning systems (ERP)
  • CRM
• Clinical and pharmacovigilance systems
• Document and record management systems
• Data collection and monitoring systems
• Document and record management systems

Regulatory Compliance

Computer systems validation (CSV) is essential for ensuring your adherence to all relevant UK and international regulations and minimises your risk of regulatory findings, recalls, or enforcement actions, keeping your systems ready for inspections and audits.

Data Integrity and Security

Effective CSV ensures robust data integrity. Data will always be trustworthy as attributes like accuracy, consistency, and controls such as security, are fundamental to the process.

Cost Savings

Significantly, computer systems validation reduces the risk of costly rework, recalls, and system failures and makes upgrades, migrations, and audits far easier and less disruptive. This process helps to optimise the system’s total cost of ownership.

Better Product Quality

By understanding your requirements and the associated risks, the quality of your manufacturing and product testing will be enhanced by effective computer systems validation. A focus on critical system functions and data helps to reduce variability and improve accuracy, leading to higher quality outcomes for batch consistency and product quality.

Improved Efficiency

Computer systems validation streamlines system processes and workflows which, in turn, reduces manual work, revalidation, and human error. By selecting the appropriate types and level of validation techniques and deliverables, a right first time approach can be achieved, enhances operational consistency and productivity.

Computer systems validation is essential in any regulated industry where data integrity, product quality, and patient safety are paramount. These sectors are typically governed by strict compliance frameworks such as GMP, GCP, GDP, and GVP and regulated by authorities such as the MHRA, FDA, and EMA. This could include any of the following:

• Pharmaceuticals
• Biotechnology
• Medical devices
• Clinical research
• Healthcare and NHS trusts
• Veterinary medicines

BPV delivers comprehensive CSV services that ensure your systems are fit for purpose (in terms of design, performance, and reliability) and are compliant with stringent regulatory requirements.

Our core computer validation services consist of:

• Full system lifecycle validation (using GAMP 5 methodology)
• System assessment and gap analysis
• Data integrity assessment and remediation
• Retrospective Computer System Validation
• Validation protocol and report writing
• Training and development of support processes
  • System periodic review
  • Configuration management

Our computer systems validation services are delivered in alignment with all globally recognised regulatory and industry frameworks. We adhere strictly to every applicable standard including GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and MHRA data integrity guidance.

Our team is highly trained in the best practices established by ISPE and our validation documentation is fully compliant with GxP, ensuring readiness for inspections by bodies such as the MHRA, EMA, and FDA. Our quality management approach is underpinned by ISO 9001 principles, ensuring consistency, traceability, and continual improvement across all validation activities.

Arranging our computer systems validation services is a straightforward and collaborative process tailored to meet your regulatory and operational needs. No matter your validation needs, our expert team will guide you through each step, from project scoping and costing to initial risk assessments and User Requirements Specification (URS) to developing and executing validation protocols. We work closely with you to ensure full GxP compliance, data integrity, and audit readiness.

To take advantage of our team’s expertise in computer systems validation, contact our friendly team to schedule a consultation to define your scope, timelines, and deliverables based on your business and regulatory objectives.

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 20 years of 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.