FicusRealtime helps organizations navigate the complex landscape of regulatory compliance and audit preparedness with confidence. Our tailored solutions ensure alignment with national and international standards, enabling businesses to maintain operational integrity, ensure patient safety, and avoid regulatory penalties.
21 CFR Part 11 – FDA regulations for electronic records and electronic signatures
EU GMP Annex 11 – Requirements for computerized systems in pharmaceuticals
ISO 9001:2015 – Quality management systems standard
ICH Q10 – Pharmaceutical Quality System framework
WHO GMP Guidelines – For global drug manufacturing standards
GAMP 5 – Guidelines for validating automated systems
MHRA & CDSCO Compliance – Local regulatory bodies in UK & India
Audit Compliance Services
FicusRealtime prepares your organization to face internal and external audits without disruption:
Audit Trail & Data Integrity:
Capture every action with tamper-proof audit trails. Ensure ALCOA+ principles for data integrity.
Validation & Documentation:
Full lifecycle validation support for computerized systems (CSV), including IQ/OQ/PQ protocols.
SOP Standardization:
Harmonized and compliant Standard Operating Procedures (SOPs) aligned with current regulatory expectations.
Gap Assessments & Remediation:
Identify compliance gaps, evaluate risks, and implement corrective actions before audits.
Electronic Record Compliance:
Ensure systems meet electronic record and signature standards (21 CFR Part 11 & Annex 11).
Industry-Specific Software for Enhanced Quality and Compliance
Testimonials
20K+ Satisfied Clients World Wide
Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
MANGALAM ORGANICS LIMITED
VINS BIOPRODUCTS LIMITED
ORCH LABORATORIES INDIA PVT.LTD
EXTROVIS PRIVATE LIMITED
ISO QUALITY MANAGEMENT SYSTEM
NSJ PRAYOG LIFE SCIENCES PVT.LTD
