Services
We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.
Training/Education
We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.
Fundamental of Computerized System Validation
A software application or a computerized system needs to be planned and implemented. Therefore, the use of a system life cycle is important as it provides a plan to use as a basis for the implementation or building of a computerized system
SOPs and Validation Deliverables
Validation Master Plan. CSV SOPs. How to write appropriate specification (URS), Risk Assessment and other GAMP Methodology validation deliverables. Vendor Assessment. Data backup and restoration Verification Audit trail review
21 CFR Part 11 and (Annex 11 – 1)
Evaluation and Key requirements of 21 CFR part 11. Evaluation and Key requirements of Annex 11. Relationship between Part 11 and Annex 11.
21 CFR Part 11 and (Annex 11 – 2)
Learning form 483: Warning letter are key wealth destroyer for pharma company market capital and reputation. Inspection Readiness.
Data integrity
Understanding of Data Integrity Fundamentals. Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS: What are the similarities and differences between the guidance? Understand with examples difference between improper practice and data integrity.