SOLUTIONS
Practical Validation Solutions for Regulated Industries
Validation is often viewed as a compliance necessity rather than an operational advantage. However, when done correctly, it ensures systems and equipment function as intended, reduces business risks, and prevents costly regulatory failures.
At ITS, we provide a structured, risk-based approach to validation, covering the entire lifecycle of systems, equipment, and software.
Our expertise extends across pharmaceuticals, medical devices, energy, logistics, and industrial automation, ensuring compliance with 21 CFR Part 11, Part 211, Part 820, Eudralex Annex 11 & 15, GAMP 5, and ICH Q9 R1.
Validation & Verification Beyond Life Sciences
Validation challenges aren’t limited to pharmaceuticals and medical devices. Energy, industrial automation, and other regulated sectors also face compliance risks, unclear validation requirements, and last-minute regulatory pressure.
ITS applies verification testing to engineering projects in the energy sector and beyond, ensuring that equipment, systems, and processes meet industry standards and regulatory expectations.
By defining requirements early, integrating validation into project timelines, and rigorously testing systems before deployment, we help businesses eliminate compliance risks and maintain operational reliability.
VALIDATION & VERIFICATION SERVICES
SERVICES INCLUDE, NOT LIMITED TO:
01
Equipment Validation
ITS ensures equipment meets operational and regulatory requirements from the start. We develop User Requirement Specifications (URS) to prevent costly changes later and take a risk-based approach to focus validation where it matters. Our team manages Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) across GMP and non-GMP industries, including energy and industrial automation.
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Computer System Validation (CSV)
ITS validates software, hardware, and network infrastructure to meet 21 CFR Part 11, Annex 11, and GAMP 5 standards. We specialise in cloud-based and SaaS validation, ensuring security, compliance, and scalability. Through risk assessments and remediation planning, we help businesses prevent data integrity issues before they become audit risks.
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Data Integrity & Compliance
Regulatory audits often expose data integrity gaps, putting businesses at risk. ITS conducts compliance audits, gap analyses, and remediation planning to strengthen data security and traceability. We provide Validation Master Plans (VMPs), traceability matrices, and summary reports, ensuring businesses maintain audit-ready, well-documented validation processes.
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Service Level Agreements (SLA)
ITS’ Service Level Agreements (SLAs) are tailored to meet each company’s requirements and they are designed to improve uptime, reliability and production efficiency. The SLAs are flexible and can incorporate a range of services including preventive maintenance, system back-ups, 24-7-365 on-call support, consultancy, software development, training and maintenance activities.
MORE INFOMeeting Global Regulatory Standards In Validation & Verification
Industry-Specific Validation Strategies for Compliance & Risk Management
Our validation services align with global regulatory requirements, ensuring businesses comply with 21 CFR Part 11 for electronic records, Eudralex Annex 15 for qualification and validation, and ICH Q9 for risk management.
We integrate these standards into computer system validation, equipment validation, process validation, and data integrity assessments, helping businesses in pharmaceuticals, medical devices, energy, and industrial automation maintain compliance and efficiency.
By applying risk-based validation approaches, we eliminate last-minute regulatory challenges and adapt validation strategies to the specific needs of each industry.
INDUSTRIES
Proven Validation Success Across Industries
Our validation expertise is backed by real-world projects across regulated industries.
We have successfully completed the commissioning and validation of water storage and distribution systems for pharmaceutical clients, conducted periodic review and requalification of laboratory equipment, and performed validation and qualification for API equipment, including pumps, heat exchangers, and critical process equipment.
Our team has validated software solutions for manufacturing and packing systems, ensuring compliance with data integrity requirements. We have also provided CSV and risk assessment services for SaaS-based master control systems, ensuring secure validation for cloud-hosted platforms.
DIGITAL BROCHURE
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FAQ
Here to Help with Validation & Verification Services
To help answer any questions you may have, we’ve compiled a list of frequently asked questions to provide you with the information you need to make an informed decision about working with ITS.
What experience does ITS bring to validation projects?
ITS is led by a team of validation professionals with extensive experience across multiple industries. Our team includes senior validation engineers, consultants, and project managers who specialise in equipment qualification, computer system validation, and process validation. We work closely with clients to ensure validation processes align with their specific operational needs. Whether you require support for a single project or long-term validation management, our team provides expert guidance and execution.
Why should businesses choose ITS for validation and verification?
ITS brings a structured, risk-based approach to validation, ensuring that compliance efforts are focused on what truly matters. Our experience in pharmaceuticals, medical devices, energy, and industrial automation allows us to provide tailored validation solutions that align with both regulatory requirements and business goals. We understand that validation is more than just a regulatory checkbox, it is a key component of operational reliability and quality control. By integrating validation into project timelines and focusing on high-impact areas, we help businesses maintain compliance while improving efficiency.
What industries does ITS support with validation services?
ITS provides validation services for pharmaceuticals, medical devices, energy, automation, and industrial manufacturing. Our work ensures compliance with FDA, EMA, MHRA, ISO, and GAMP 5 standards while aligning validation efforts with operational goals.
How does ITS approach risk-based validation?
We prioritise high-risk system functions, reducing unnecessary testing while ensuring compliance. This approach saves time, avoids redundant validation steps, and ensures systems are fit for purpose without excessive documentation.
Can ITS assist businesses that don’t have in-house validation teams?
Yes. ITS can provide turnkey validation lifecycle solutions, helping SMEs and large enterprises establish structured, compliant validation processes without the overhead of a full in-house team. We offer both short-term validation support and long-term validation resource services.
What happens if a validation test fails?
If a validation test fails, ITS conducts a root cause analysis, documents deviations, and implements corrective actions. Our structured approach ensures that failures are addressed efficiently, reducing project delays and maintaining compliance.
How can I work with ITS for validation support?
Validation should not be a last-minute challenge. With the right approach, it becomes a seamless part of your operations, reducing compliance risks and ensuring reliable system performance. Contact ITS today to discuss your validation and verification requirements.
UPCOMING TRAINING COURSES
Check out what training is happening next.
24/02 2025
Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme
Duration: 3 days
Attendee Slots: 10 Places Left
At ITS we have more courses and dates available please see the full calendar.
Very professional and have delivered all my projects on time.
ITS gets the job done in a friendly manner.