Compliance Gurus excels in delivering compliance auditing services tailored for the Life Sciences industry, ensuring life sciences IT compliance through expert software vendor audits, Computer System Validation (CSV), and Computer Software Assurance (CSA) audits. Our rigorous approach guarantees your GxP compliance software meets the FDA’s 21 CFR Part 11 and global standards, safeguarding your operations.
Vendor Audits for GxP Software
The FDA mandates that regulated organizations conduct due diligence on software vendors before selecting, validating, and implementing GxP compliance software. Too often, clients purchase GxP applications without a vendor audit, risking non-compliance. Compliance Gurus strongly recommends auditing vendors prior to selection to verify 21 CFR Part 11 compliance, assess customization needs, and determine ownership costs. Our compliance auditing services guide you through every step, ensuring CSV audit readiness and robust GMP software validation.
For clients who’ve already selected software, we can perform audits before implementation, leveraging GAMP 5 software categorization to evaluate system suitability and compliance. We advise against purchasing vendor-provided validation templates, as 95% lack the expertise for FDA compliance. Our team has successfully updated non-compliant vendor templates to meet regulatory standards.
Periodic Reviews for Sustained Compliance
Periodic reviews, as required by 21 CFR Part 11, ensure your GxP applications remain validated throughout their lifecycle. Our life sciences IT compliance expertise includes one-off assessments of CSV and CSA validation packages, ideal for small to medium-sized organizations lacking in-house SMEs. We ensure audit trail validation and compliance with regulatory standards, keeping your systems audit-ready.
With our GMP software validation and GAMP 5 software categorization expertise, Compliance Gurus delivers tailored solutions to maintain CSV audit readiness, protecting your organization from regulatory risks and ensuring seamless inspections.
Why Choose Compliance Gurus?
Our compliance auditing services empower your organization with confidence in GxP compliance software. From vendor audits to periodic reviews, we ensure compliance with FDA, EMA, and global standards, leveraging audit trail validation to secure data integrity. Trust us to keep your systems compliant and your business thriving.
Talk with Us to strengthen your life sciences IT compliance today.
