Driving Digital Transformation through Tailored Services
One that emphasizes AI, risk-based approaches, or regulatory compliance more directly?
Our Vision
At HK Tech, our vision is to redefine excellence in validation services by integrating deep industry expertise with cutting-edge technology. We are committed to becoming the trusted partner of choice for pharmaceutical, biotechnology, and life sciences companies by delivering robust, compliant, and efficient CSV, CQV, and validation solutions.
We envision a future where quality, compliance, and innovation work hand in hand—empowering our clients to accelerate product development, ensure patient safety, and meet global regulatory expectations with confidence.
Through our vision, we aim to:
- Elevate compliance standards with data-driven, risk-based, and lifecycle approaches to validation.
- Streamline validation processes using automation, AI, and digital tools to reduce manual burden and boost productivity.
- Foster a culture of continuous improvement that anticipates regulatory changes and adapts proactively.
- Build long-term partnerships by delivering tailored solutions that align with your strategic goals and operational needs.
Our promise is simple: to deliver solutions that are fit for purpose, audit-ready, and future-proof—so you can focus on what matters most: delivering safe, effective therapies to patients worldwide. Stay ahead of the curve in the ever-evolving world of technology.
Our Services
Validation & Compliance Services Overview
Computer System Validation (CSV)
- Risk-based validation strategies (aligned with GAMP 5 & 21 CFR Part 11)
- Validation of GxP systems (LIMS, ERP, QMS, EDMS, MES, etc.)
- Validation planning, protocol development (IQ, OQ, PQ), and reporting
- Data integrity and audit trail review
- Cloud-based and SaaS system validation
- CSA (Computer Software Assurance) implementation support
Commissioning, Qualification & Validation (CQV)
- Facility, utility, and equipment qualification (FAT, SAT, IQ/OQ/PQ)
- HVAC, cleanroom, and water system qualification
- Process validation (PPQ, Continued Process Verification)
- Temperature mapping and environmental monitoring validation
- Calibration program support and vendor coordination
Computer Software Assurance (CSA)
- Transition strategy from CSV to CSA in line with FDA guidance
- Risk-based assurance frameworks focusing on critical thinking
- Reduction in documentation burden through smart testing approaches
- Scriptless test automation for non-product quality impact systems
- CSA-ready templates and SOP development
- Training and change management for CSA adoption
Digital Validation Solutions
- Digital validation lifecycle management tools
- Paperless validation implementation
- AI-driven risk assessment and test automation
- Validation metrics dashboards and analytics
Quality Systems & Lifecycle Services
- QMS design, implementation, and remediation
- Lifecycle documentation and change control support
- Vendor qualification and third-party audits
- Periodic reviews and revalidation strategy
Additional Services
- Consulting & Advisory: Need guidance on building your team or improving your hiring strategy? We offer consulting services to help you navigate the complexities of tech recruitment.
- Staffing & Recruitment: From permanent placements to contract-based roles, we help businesses fill crucial IT positions with top talent.
- Executive Search: Our specialized executive search services focus on finding leadership talent to guide your company through its next growth phase.
Our Expertise
CSV/CQV/CSA
For highly regulated industries like pharmaceuticals, biotech, and healthcare, we provide specialized validation experts who ensure that your systems comply with industry standards and regulatory requirements. Our candidates bring experience in validating critical systems, including GxP, FDA, and other global regulations, ensuring data integrity and operational efficiency.
Business Analyst (BA)
We connect you with experienced business analysts who understand the complexities of IT systems and business processes. Our BAs bridge the gap between stakeholders and technical teams, ensuring that your projects are delivered on time, within scope, and aligned with your strategic objectives.
Quality Assurance (QA)
Quality Assurance (QA)
Our QA professionals ensure that your software meets the highest standards of quality and reliability. From manual testing to automation, we provide skilled QA engineers experienced in various testing frameworks and tools, helping you deliver flawless software products with confidence.
DevOps
Quality Assurance (QA)
We connect businesses with expert DevOps engineers who streamline development pipelines, enhance automation, and foster collaboration between development and operations teams. Our candidates are skilled in cloud platforms, CI/CD, containerization, and infrastructure as code, ensuring faster and more efficient software delivery.
AI/ML
AI/ML
Our AI/ML engineers are adept at designing and implementing intelligent systems that drive automation and data-driven insights. Whether it’s natural language processing, computer vision, or predictive modeling, we recruit top talent who bring expertise in machine learning algorithms, AI frameworks, and data pipelines, helping your business harness the full potential of AI.
MLOps
AI/ML
Our MLOps professionals bridge the gap between data science and operations, optimizing machine learning workflows and automating deployment, scaling, and monitoring of ML models. We source talent proficient in cloud environments, model versioning, and continuous integration to enable seamless production-level machine learning solutions