In the highly regulated life sciences sector, digitalisation is transforming how companies manage data, processes, and regulatory compliance.
But these advancements also bring new risks: data integrity breaches, outdated validation procedures, and misaligned systems can jeopardise operations and inspection outcomes.
Rephine’s Digital HealthCheck gives you a clear, structured, and compliance-focused review of your computerised systems, aligning them with current GxP expectations and data integrity principles.
Our proven methodology ensures that we don’t just focus on compliance—but also on the digital maturity and efficiency of your systems. We provide a comprehensive evaluation across:
We assess the life cycle management of your systems to verify alignment with GMP guidelines, including change control, user access, system governance, and qualification practices.
🔹 2. Data Integrity Risk Assessment
We identify weaknesses in your systems that may compromise the accuracy, reliability, or trustworthiness of your data, and help define CAPAs to mitigate those risks.
We evaluate whether your systems meet global requirements (e.g. FDA 21 CFR Part 11, EU GMP Annex 11) related to secure, compliant handling of electronic records and signatures.
We visualise the flow of GxP-relevant data to help clarify critical control points, reduce complexity, and support audit readiness.
We analyse your periodic review practices to ensure system integrity is maintained throughout the system’s lifecycle, even after implementation.
✅ Avoid inspection findings due to system or data issues
✅ Improve overall compliance posture across digital operations
✅ Gain insights into your system landscape and data handling maturity
✅ Identify high-risk gaps and define a practical mitigation plan
✅ Strengthen audit readiness and maintain validation status
Rephine is a global consultancy specialising in GxP compliance, CSV, and data integrity across pharma, biotech, and medtech companies. With offices in the UK, Spain, India, and China, our team of experts has decades of experience navigating the latest regulatory expectations for digital systems.
We understand that digital transformation in regulated environments must go hand-in-hand with robust compliance strategies—and we’re here to guide you every step of the way.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
REPHINE CHINA
REPHINE INDIA
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