VALCAL Lifesciences Pvt. Ltd. Provides Quality Computer System Validation Services to the Pharmaceutical, Biotechnology and Medical Device Industries. We have the team of talented and committed people to take care and provide excellent services for all type of regulatory requirements. We offer a full list of services such as Software Validation of Computer System, HPLC –PLC, DCS-SCADA, SAP-ERP Software, and BMS. Training and 21 CFR Part 11 Compliance Audit and much more. Quality Validation Work, complete responsibility from start to finish, personalized support and the success of your projects at best price are the foundation of our company.
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- Facilities qualification
- Equipment qualification
- It infrastructure qualification
- Regulatory compliances services
- Plc – programmable logic controllers validation
- Dcs / scada /vision system validation
- Sap r/3 erp validation
- Pc validation
- Excel sheet, network validation
- Lab equipment validation
- Hplc, gc, ftir, stability chamber software -enviro etc..
- Laboratory information management system (lims).
- Computer system application software validation
- Bms/ems validation system – sauter, honeywell, siemens, johnsons
- Clinical research software
- Clinical trial application software, pe access, sas, win non lin, application.
- Software validation
- Preparation of sops.
- Third party vendor audit.
- 21 cfr part 11 compliance audit training for gmp, gamp4-5, 21 cfr part 11 compliance
- Plc/hmi/csv/bms/scada system validation etc.
- Clean room validation
- Thermal validation
- Laf/rlf/dpb/ isolator/ biosafety cabinets/rabs etc.
- Compressed air / nitrogen /steam quality test / utility validation etc.
- Laboratory system validation.
- Calibration of instruments.
- Autoclave/dhs/sterilization tunnel validation (thermal mapping) etc.
- Incubators/stability chambers/ oven validation etc.
- Qualifications (iq, oq & pq)/validations/calibrations in the greenfield projects.
- Ware house mapping /cold rooms/deep frezer (temp & rh) etc.
- Validation/qualification/commissioning/compliance for all system.
- Quality system documentation development (gap analysis /sop/protocol).
- Training programs on current approach of cgmp/validation/cleaning validation / qbd/audit/ aseptic behaviour/ regulatory requirements /qms/qc/pv etc.
- Consultancy services for the validation qualification quality system for green filed project or up gradation projects.
- Yearly contract and sub contract system.
- Quick and professional services.
- Customer audit support online 24*7.
- Online documentation of the executed activities.
- Pharmaceutical instruments/equipment trading.
- Lab chemical /material supply.
- Raw material supply.
- Hospital, institutional material/ instrument/equipment diagnostic kit etc. Supply
- Technical team resourcing.
- Technical support/management.
- Compliance management