URS Built with Deep Pharma Insight and Smart IT Capabilities — From the Start
Risk Based Qualification IRA, PVP, IQ, OQ, PQ, RTM, PVR, SOP etc.
Development of Engineering and CSV Qualification documents including URS, FAT, DQ, Component Risk Assessment, IQ, Privilege Matrix, OQ, PQ, RTM
On-site execution of qualification
Development of Business Intelligence dashboards.
Server integration for online / scheduled data analysis.
Development of spreadsheet and validation of the same
Technical Writing
Advanced RCI
Data Integrity
Contamination Control
Cleaning Validation
QMM | CSV | Q&V
Digital Proficiency for Pharma Professionals:Software Operations
Excel | Word | PPT | PBI
Animated visuals | Human-like voiceover | Highly Interactive | Animated visuals
SOP Training Content | Good Practices Modules | Operation Manuals
Industry Readiness Programs for the students and new professionals in regulated pharma organization
Third Party Audit
Audit Readiness
System Audits
Product Audits
Data Integrity Gap Assessment
SOP Gap Assessment
Contamination risk and gap assessment.
Revising / Creating SOPs, Policies as needed.
Validation Document Review
Part 11 Compliance Gap Assessment
Procedure Gap Assessment
