PLC /CSV Validation services compliant to 21CFR part 11/Annex 11 regulations in pharmaceutical industry. We undertake complete turnkey Validations.
Services Offered
- Programmable Logic Control (PLC )
- Supervisory Control & Data Acquisition (SCADA/DAS) Systems
- Computer System Validation
- Validate Building Management (BMS) & Environment Control Systems
- Human Machine Interface (HMI/MMI) System
- Distributed Control Systems ( DCS )
- Computer Based Systems in Laboratory like HPLC, GC, UV, Moisture Balance etc.
- Excel sheet validation
Our Supports
- Most appropriate & latest GAMP 5, PICS, 21 CFR Part 11, EU Annex 11 guideline based Compliance services for your new / legacy systems.
- Organizing and Executing Activities at client’s plants.
- Preparation of Protocols & Validation related Documentation as per Regulatory & Clients requirements.
- Accountable for completing activities as per Schedule, Proper Coordination with Client.
- Understanding Clients requirement. Preparation for Vendor Audits requires a thorough knowledge/ understanding of validation principles and quality philosophies.
- Implementation of company’s first self-directed work teams resulting in a flat organization.
- Planning, development and direction of Quality programs.
- Complete Validation of system includes designing of VMP, 21 CFR Compliance report, RISK Assessment, GAP Analysis, DQ, FDS, IQ, OQ, PQ, Validation summary report and Traceability Matrix.
