IT Quality Assurance responsibilities in the regulated life sciences sector
In the regulated industries, such as pharmaceuticals and medical devices, IT Quality Assurance (QA) departments play a pivotal role in ensuring that computerized systems meet regulatory requirements and guarantying reliability, accuracy, and consistency of data.
With the rapid evolution of digitalization in this sector, IT QA professionals are becoming essential elements in inspections or audits.
Understanding the IT QA Role
a. System Validation
One of the main responsibilities of IT QA professionals is ensuring that software, systems, or applications meet specified users and regulatory requirements. This role is fundamental across the software development lifecycle (SDLC). Among other functions they should:
- Understand business requirements to define and write validation documents and to define the best plans/strategies.
- Execute and document Computer System Validation (CSV) processes to meet regulatory standards like FDA 21 CFR Part 11.
- Ensure that validation and SDLC documentation is robust and with the expected quality provides the required evidence for inspections.
b. Data Integrity
Data integrity is at the heart of regulated IT systems. IT QA should ensure that data is reliable, accurate, and traceable throughout its lifecycle. Responsibilities include:
- Validation: Validate systems to ensure ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, etc.) are followed.
- Audit Trails: Establishing comprehensive audit trails that track who made changes to data, when, and why.
- Data Verification: Regular checks to confirm that data is correct, complete, and has not been altered or tampered with.
c. Regulatory Compliance
IT QA professionals ensure that systems meet industry standards set by regulatory bodies such as the FDA, EMA, and ISO. Their role includes:
- Document Management: Ensuring that all records and documents are stored, accessed, and transmitted securely to comply with regulatory guidelines.
- Compliance Audits: Regular audits to ensure systems and processes remain compliant with both local and international regulations.
d. Security
Security is not just an IT function, it’s a shared responsibility, and IT QA plays a critical role in ensuring systems are not only functional but also secure and compliant.
IT QA ensures that systems and sensitive data are protected in front of unauthorized access. IT QAs are responsible for Implementing role-based access controls to ensure that only authorized personnel can access critical systems or data.
e. Risk Management
Risk management is a critical aspect of IT QA, where system failures or data issues can lead to compliance violations, patient harm, or product recalls.
The IT QA team helps with identifying, assessing, and mitigating IT risks to ensure patient safety, system reliability, data integrity, and regulatory compliance.
f. IT Governance procedures maintenance
Risk management is a critical aspect of IT QA, where system failures or data issues can lead to compliance violations, patient harm, or product recalls.
The IT QA team helps with identifying, assessing, and mitigating IT risks to ensure patient safety, system reliability, data integrity, and regulatory compliance
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g. Audit/inspections readiness
Preparing for internal, external, or regulatory audits by demonstrating compliance, data integrity, and validated systems.
h. Change Control management
Change Management is a formal process used to ensure that any modifications to IT systems, applications, or infrastructure are assessed, tested, approved, and documented to maintain system integrity, functionality, and regulatory compliance.
In regulated environments, IT QA plays a crucial gatekeeping role to ensure
- Changes are implemented in a controlled and traceable manner.
- Systems remain validated and compliant after changes.
- There is minimal disruption to business-critical or GxP operations.
i. Incidents/Deviations management for IT systems
In IT QA, especially in regulated industries like pharma, the goal is to evaluate and resolve issues quickly to minimize downtime but always.
- Documenting everything for traceability and audits.
- Ensuring compliance with regulatory requirements (FDA, EMA).
- Analyze the incidents to prevent recurrence via root cause analysis and CAPA (Corrective and Preventive Action).
Rephine’s Role in IT QA
We bring comprehensive experience in supporting IT Quality Assurance (QA) functions across pharmaceutical and regulated industries, with a strong focus on compliance, validation, automation, and quality control.
Our expertise aligns with regulatory standards such as GxP, FDA 21 CFR Part 11, EU Annex 11, and industry frameworks like GAMP 5 and ICH guidelines.
Sandra Lacruz
CSV Consulting Line Director
Final Thoughts
As someone who collaborates daily with QA teams, IT stakeholders, and regulatory bodies, I’ve seen how a strong IT Quality Assurance function can make the difference between smooth inspections and costly delays. Validation, data integrity, and change control aren’t just compliance checkboxes—they’re critical to delivering safe, reliable, and regulatory-ready systems.
IT QA must be integrated early and maintained throughout the system lifecycle. When embedded into every phase—from requirements through to incident management—it becomes a powerful enabler of compliance, audit readiness, and operational resilience.
If IT QA is still treated as an afterthought in your organisation, now is the time to bring it to the forefront.