Computerized System Validation
Our Vision
In a world of global economy, it is critical to maintain exceptionally high-quality levels . With commodities, consumer packaged goods, medical devices and pharmaceutical drugs being widely dispersed around the globe and consumers more demanding than ever, quality is now in the forefront of all manufacturing companies.
Even the slightest deviation from protocol can cause a ripple effect with devastating consequences on lives, financial results and brand name.
With regulators more involved and meticulous now than ever before, electronic quality management systems (EQMS) evolving quickly and quality requiring significantly more resources, organizations look for a professional, knowledgeable and experienced partner that can guide them to the right solution, reduce workload and overhead while cutting costs and improving quality.
Qualioo is a dedicated consultancy company, focused on delivering innovative solutions to pharmaceutical, medical device, chemical, consumer packaged goods, food & beverage and companies from other industries.
“Achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.”
Qualioo’s experienced staff provides extensive expertise of IT and Business Process in the pharmaceutical industries, as well as FDA compliance, audit, and validation skills to Life Science projects. We work to ensure that unique requirements of firms working in a regulated environment are satisfied.
The general approach to validation (a crucial 21 CFR Part 11 requirement) at Qualioo Consulting is to create and manage systems with a focus on quality throughout the System Lifecycle. With an increase in demand that the validation effort be rational, controlled, efficient, and cost-effective we follow GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems to achieve these goals.
Paperless validation software revolutionises traditional validation procedures, and the industry is moving towards it. The dependency on hardcopy documentation is reduced with paperless validation, making the total validation lifecycle substantially more efficient. We assist organizations in implementing an electronic system to manage the corporate validation process to ensure consistency, improve compliance, and standardise the validation lifecycle procedures.
Our certified CSV experts helps to:
- Perform administrative tasks to support Computer System Validation of both GxP and Non-GxP IT systems.
- Maintain systems as per Computer system validation SOP, SDLC SOP and GxP in validated state.
- New enhancements/Bug fixes/new release testing and promotion to production.
- Perform gap analysis against established regulatory guidelines and industry best practices.
- Perform vendor audit and system risk assessment for retired and new features.
- Develop upgrade and validation plan.
- Develop user requirements and functional risk assessment.
- Develop functional and technical design specifications.
- Develop IQ, OQ, PQ protocol, scripts, and reports.
- Develop traceability matrix and validation summary report.
- Develop training materials and train users.
- Develop procedures and work instructions.
- Follow Good Documentation Practice.
Life Sciences organizations can leverage Qualioo’s GxP CSV services to reduce costs and improve the standard of compliance.
Computerized systems shall be implemented using a methodology that ensures that validation deliverables are developed in a logical and predictable manner. Our Project Team will be responsible for producing the following standard validation deliverables:
Standard Validation Deliverables:
- Validation Master Plan
- Change Request
- User Requirement Specification
- Functional Requirement Specification
- Risk Assessment
- IT Vendor Assessment
- Validation Plan
- System Design Document
- Validation Protocols
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Trace Matrices
- CFR Part 11 Compliance Assessment
- Validation Summary Report
- System SOPs and Guidelines
- Validated System Maintenance
- Retirement Plan
Validation Master Plan
Trace Matrices
Validation Plan
Change Request
System Design Document
CFR Part 11 Compliance Assessment
User Requirement Specification
Validation Protocols
Validation Summary Report
Functional Requirement Specification
Installation Qualification (IQ)
System SOPs and Guidelines
Risk Assessment
Operational Qualification (OQ)
Validated System Maintenance
IT Vendor Assessment
Performance Qualification (PQ)
Retirement Plan