Regulated Pharma and MedTech manufacturers must demonstrate that their computerised systems, equipment and manufacturing processes operate in a controlled and compliant state throughout their lifecycle. Regulatory frameworks such as GAMP® 5, FDA 21 CFR Part 11 and EU Annex 11 require documented, risk-based validation supported by robust governance and data integrity controls.
Validation Guided by Global Excellence: The Gold Standard
With over 30 years’ experience providing validation services to leaders in the Life Sciences sector, DataWorks supports regulated manufacturers with computer system validation, equipment validation and process validation. Our manufacturing and software development expertise enables us to validate your systems onsite or remotely, ensuring compliance with GAMP® 5 guidance, FDA 21 CFR Part 11 and EU Annex 11.
Effective validation requires coordination between Quality, Engineering, IT, Automation and Manufacturing teams. We work closely with system developers, equipment vendors and operational stakeholders to ensure validation activities are aligned, risk-based and inspection-ready — while remaining understandable to both technical and non-technical decision-makers.
Our validation engineers work in partnership with your team to deliver compliant and efficient validation programmes. Whether you require full-time onsite support or specialist expertise for a specific project, our engineers integrate seamlessly with your operations.
We provide flexible and scalable validation resources to support computer system validation, equipment qualification and process validation activities. By working alongside your team—or providing additional expertise when required—we ensure validation programmes progress efficiently, meet regulatory compliance requirements and support your operational goals.
Computer Software Assurance (CSA) is the FDA’s modern risk-based approach to validating software used in regulated manufacturing environments. Rather than focusing on extensive documentation, CSA emphasises critical thinking and risk-based testing to ensure systems that impact product quality, patient safety and data integrity are verified appropriately.
At DataWorks, we have adopted the FDA’s CSA framework to help Life Sciences organisations move beyond traditional document-heavy validation. Our approach focuses effort where it adds the greatest value—prioritising testing of high-risk system functions while reducing unnecessary documentation. Using proven validation assets and standardised protocols, we apply an 80/20 model: concentrating the majority of effort on meaningful testing and a smaller portion on documentation. This enables faster validation cycles while maintaining full regulatory compliance.CSA is particularly suited to validating non-product software applications such as:
Computer System Validation (CSV) ensures that computerised systems consistently operate in accordance with their intended use and regulatory requirements. As digital transformation accelerates across pharmaceutical and medical device manufacturing, maintaining validated systems and strong data integrity controls is critical for regulatory compliance.
DataWorks delivers comprehensive CSV services aligned with GAMP® 5 lifecycle guidance, supporting compliance with FDA 21 CFR Part 11 and EU Annex 11. Our validation engineers work across pharmaceutical, medical device and supply chain environments to ensure systems such as MES, ERP and automation platforms remain fully validated and audit-ready. Beyond validation execution, we help organisations strengthen their data integrity and governance frameworks. Through structured risk assessments, system inventories and data lifecycle analysis, we support the development of robust validation strategies that protect product quality, ensure regulatory compliance and maintain trusted digital records.
In an increasingly automated industry, Data Integrity is the foundation of regulatory compliance. To mitigate risk and ensure audit readiness, your organization needs a proactive Data Governance strategy. Dataworks provides the expertise to build robust data lifecycles, ensuring your digital records meet the highest standards of safety and quality.
We have created a sophisticated and structured framework designed to transition your organisation from reactive fixes to a proactive and adaptive state of Data Integrity. Most companies struggle with Data Integrity because they lack a consistent method for assessing risk across departments. Using our Data Integrity “Playbook”, we provide a standardised methodology to evaluate your current maturity level to provide a clear, audit ready path.
Our validation team will deploy the DI playbook onsite with a comprehensive deliverable package including:
Driving cross-functional accountability through seamless departmental integration and rigorous regulatory alignment.
DI Offering Overview
Essential to Data Integrity
Using the GAMP® 5 (Second Edition) lifecycle framework, organisations can ensure their automated systems and software meet global GMP quality standards while maintaining control across complex digital manufacturing environments. Aligning validation activities with GAMP® 5 enables manufacturers to demonstrate regulatory compliance, strengthen data integrity and maintain audit-ready systems throughout the validation lifecycle.
For organisations operating across the ISA-95 automation hierarchy, effective validation must bridge the gap between shop-floor equipment and enterprise software systems. By integrating validation across hardware, automation and digital platforms, companies can reduce risk, improve operational efficiency and maintain consistent compliance across manufacturing operations.
Whether aligning internal policies with evolving regulatory requirements or executing the full validation lifecycle—from Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) through Control Software Qualification (CSQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)—a structured validation approach ensures equipment performance, regulatory compliance and long-term operational reliability.
Process validation ensures that pharmaceutical manufacturing processes consistently produce products that meet predetermined quality and regulatory requirements. Regulators expect a lifecycle approach that includes process design, process qualification (IQ, OQ, PQ), and continued process verification to demonstrate that critical process parameters remain controlled over time. By applying structured validation practices aligned with GMP guidance, organisations can maintain reliable production processes, ensure product quality and safety, and remain fully prepared for regulatory inspections.
Having worked extensively in pharmaceutical, medical device and medical supply environments for many years, our engineers can help you with all your documentation needs across a project. This can include project documentation, risk assessments, user and technical specifications, validation protocols and test scripts, and any operational SOP’s and or training manuals.
We can work closely with your team to deliver your documentation requirements that comply with your own policies and best industry practices. We offer a flexible engagement model where we can provide a turnkey solution or simply provide you with additional resources to work as part of your project team.
Artificial intelligence (AI) is increasingly being used in regulated manufacturing environments for advanced analytics, automation and process optimisation. As AI-driven systems become more common in pharmaceutical and medical technology industries, organisations must ensure they meet the same validation, data integrity and regulatory compliance requirements as traditional computerised systems. Applying risk-based validation approaches such as GAMP® 5 and Computer Software Assurance (CSA) helps ensure AI-enabled technologies remain reliable, compliant and audit-ready.
Manage your needs in a cost effective way by using our resources in a flexible manner.
We provide Project Management expertise for software and equipment validations, in addition to providing resources to work across the validation life cycle.
Our Quality Management System is ISO 9001:2015 certified, ensuring we deliver to the highest industry standards.
We believe that this is critical in any engagement with our clients. It’s a key element of building partnerships with our clients which is mutually beneficial.
For on site engagement your organisation benefits from the strong team culture fostered at Dataworks as our team integrate into your organisation.
Highly qualified resources with extensive experience working within the highly regulated Life Sciences Sector.
On-boarding of contract resources is easier for you to manage as our skilled and experienced engineers integrate seamlessly with your team.
Vice President Applications, Development and Supply Chain
