Navigating Compliance in a Complex Regulatory Environment
In today’s fast-evolving regulatory landscape, maintaining compliance with Computer System Validation (CSV) and Data Integrity standards is more critical than ever. Organisations across the pharmaceutical, biotech, and medtech industries often face significant challenges when it comes to ensuring their systems and processes are compliant and audit-ready.
If any of the scenarios below sound familiar, you’re not alone.
Common CSV Challenges
- Are you planning to implement new computer systems, either locally or at a corporate level? (ERPs, LIMS, MES, EBRs, LAB,…)
- Are you rolling out current systems across multiple sites to standardise and homogenise processes?
- Do you need to update your CSV strategy to align with the latest standards (e.g., CSA, GAMP 5 v2)?
- Are you planning to evaluate the Data Integrity compliance of your systems or processes?
- Do you need assistance in resolving Data Integrity issues?
- Are you preparing for an inspection and want to ensure Data Integrity and CSV compliance won’t be a concern?
- Have you recently implemented a Cloud (SaaS) system and are struggling to manage software releases and supplier-driven changes?
- Are you experiencing a surge in validation/revalidation activities and finding your resources stretched to maintain compliance?
- Do you have concerns about periodic system reviews or audit trail reviews?
- Are you looking to audit your IT service providers?
- Do you need to train your team on the latest CSV, CSA, and Data Integrity guidelines and regulations?
If you’ve answered “yes” to any of these questions, rest assured that Rephine is here to help you navigate these complexities.
How Rephine Can Help
At Rephine, we specialise in delivering tailored solutions to address CSV and Data Integrity challenges. With decades of expertise, our team ensures your systems and processes meet the highest standards of compliance and efficiency.
Here’s how we can support you:
Key Services We Offer
Customised Validation Services
Whether implementing new systems or standardising existing ones across multiple sites, we’ve got you covered.
CSV Strategy Updates
Align your approach with the latest standards, including CSA and GAMP 5 v2.
Comprehensive CSV Audits
Identify gaps in CSV Compliance and Data Integrity compliance and implement robust solutions.
Inspection Readiness Support
Prepare with confidence for regulatory inspections by addressing potential CSV and compliance concerns.
Cloud and SaaS Compliance
Manage the complexities of cloud-based systems, software releases, and supplier-driven changes.
Training Programmes
Equip your team with in-depth knowledge of the latest CSV, CSA, and Data Integrity requirements.
Ongoing Compliance Support
From periodic system reviews to IT provider audits, we ensure continued compliance.
Why Partner with Rephine?
Our proven methodologies and state-of-the-art documentation meet the stringent expectations of regulatory inspectors and clients alike. Whether it’s reducing costs, enhancing operational efficiency, or preparing for inspections, we’re committed to your success.
Additional Expertise
Implementation and Validation of Computerised Systems
Cloud Systems Validation
IT Infrastructure Qualification
IT Solution Supplier Audits
Training and Knowledge Sharing
At Rephine, we combine expertise with a hands-on approach to ensure your organisation is always a step ahead in compliance and validation.
Ready to Overcome Your CSV Challenges?
Don’t let CSV and Data Integrity issues hold your organisation back.
Get in touch with us today to discuss your unique requirements and explore how we can support your compliance journey.