LEAN CQV methodologies
We use lean CQV methodogies, development of the most cost effective CQV strategy while ensuring compliant delivery.Pro Delta (PDL) is a global digital service and consulting for the most complex processes in the manufacturing, R&D, and life science industries.
Our professional team supports life science companies in all aspects of the CQV lifecycle. We facilitate a timely and cost-effective solution tailored to your company’s budget and requirements. Depending on your requirements and project maturity, we could ensure a full risk-based paperless validation with integrated commissioning and test plan or make your existing paper-based IQ, OQ execution efficient. PDL prepares the testing documents and protocols. Our services includes, equipment, facility and utility testing, verification, commissioning and qualification services .
Our validation services assist our customers to meet industry requirements and guidelines established by government agencies (FDA,EU/EMA/EMEA, PMDA, TGA), industry organizations (WHO, ISO, ICH, ASTM, PDA, ISPE, CAP, USP), and industry guidelines (cGMP, cGLP, cGxP, cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211)
We use lean CQV methodogies, development of the most cost effective CQV strategy while ensuring compliant delivery.Pro Delta (PDL) is a global digital service and consulting for the most complex processes in the manufacturing, R&D, and life science industries.
Our professional team supports life science companies in all aspects of the CQV lifecycle. We facilitate a timely and cost-effective solution tailored to your company’s budget and requirements. Depending on your requirements and project maturity, we could ensure a full risk-based paperless validation with integrated commissioning and test plan or make your existing paper-based IQ, OQ execution efficient. PDL prepares the testing documents and protocols. Our services includes, equipment, facility and utility testing, verification, commissioning and qualification services .
Our validation services assist our customers to meet industry requirements and guidelines established by government agencies (FDA,EU/EMA/EMEA, PMDA, TGA), industry organizations (WHO, ISO, ICH, ASTM, PDA, ISPE, CAP, USP), and industry guidelines (cGMP, cGLP, cGxP, cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211)
Quality Focus Commissioning, Qualification and Validation Services
Our validation services assist our customers to commission, qualifying, and validating the upstream and downstream process equipment, lab equipment, computer system, Process Utility, and GMP facilities.
Our team of expert validation engineers has a focus on the quality and accuracy of all documentation provided to you for your project. we can be provided with the report, protocol, and SOP templates or we can draft documentation designed specifically for the project.
Pharmaceutical / Biopharma
Commissioning
Installation & Mechanical Competion
Functional and Integrated Testing
Training Program Defintion and Management
Cycle/Process Development and Verification
Process Equipment Qualification
Equipment Installarion and Operational Qualification
Performance Qualification and Process ValidationPackaging Lines and Package Integrity
Cleaning Process Validation
Sterilzation Validation
Installation & Mechanical Competion
Functional and Integrated Testing
Training Program Defintion and Management
Cycle/Process Development and Verification
Process Equipment Qualification
Equipment Installarion and Operational Qualification
Performance Qualification and Process ValidationPackaging Lines and Package Integrity
Cleaning Process Validation
Sterilzation Validation
