Services
We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.
Audit & Remediation
We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.
GxP Audit
We have expertise in the complete chain of audit assuring product safety and quality to clients. We provide following Audit and Solutions services. Connexo team will ensure your site is ready for any regulatory inspections.
GxP Solution Services
You can trust us for USFDA, MHRA, TGA, ANVISA, MCC, EMA and other critical Audit.
CSV Program Development
Design, develop and successfully implement Computerized System Validation Program. Develop Master Validation Plan and other CSV related Standard Operating Procedures to define the risk based validation methodology (SDLC) as advocated by ISPE’s GAMP5. Define System Security Policies to prevent data integrity and to ensure that the system is compliance with 21 CFR part 11 and Annex 11. Define approach for Data Backup restoration verification of all GxP Computerized Systems to ensure that electronic backed-up data is Complete, Enduring and Available. Design effective Disaster Recovery Plan. To lay down the approach for periodic review of the validated GxP Computerized System to ensure that the system remains compliant with regulation, is fit for its intended use, and satisfies company procedures throughout their life cycle.