PLC VALIDATION
Drug and medical device manufacturing in the modern world relies increasingly on computerized systems. Being highly regulated industries, ensuring quality and accuracy of data is paramount; and thus, Computer/Computerized System Validation (CSV) is necessary to assure that critical processes are functioning properly.
Bionic Technologies is dedicated to helping companies address the requirements in 21 CFR Part 11 Electronic Records and Electronic Signatures, and EU Annex 11 and Compu...... Read More
- Automatic manufacturing apparatus
- Control systems
- Laboratory data capture devices
- Automated laboratory equipment
- Manufacturing execution systems
- Laboratory, clinical or manufacturing database systems
- Design, develop and execute test scripts from software requirements for computer system validation.
- Generate, execute, review and complete validation documentation required, such as Traceability Matrix, URS, IQ/OQ/PQ protocols and summary reports.
- Demonstrate solid understanding of the EU and FDA validation guidelines and industry best practices
- Implement policies and procedures to validate / qualify equipment, computer systems, and processes in accordance with regulatory requirements and company standards.
- Coordinate, direct and lead validation efforts, including equipment, process, and computer system validation.
- Coordinate, direct and lead validation efforts, including equipment, process, and computer system validation.
- Facilitate and/or support validation training, change control, periodic review of validated systems,equipment and processes.
- Interface with management personnel to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met.
- Provide technical decision-making regarding cGMP compliance, regulatory issues, validation strategy and quality systems and/or strategic activities.
- Conduct root cause analysis prepare technical investigative reports and formulate recommendations for disposition and actions related to product non-conformance.
- GAP Analysis
- GXP Assessment
- GAMP Categorization
- Validation Plan(VP)
- User Requirement Specifications(URS)
- Functional Design Specifications(FDS)
- Detail Design Specifications(DDS)
- Hardware Design Specifications(HDS)
- Software Design Specifications(SDS)
- Installation Qualification(IQ)
- Operational Qualification(OQ)
- Perfomance Qualification(PQ)
- Risk Assessment(RA)
- 21 CFR PART 11 Checklist
