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Validation, in the life sciences industry, is interpreted as documented evidence which provides a high degree of assurance that a process, instrument, facility component, or computer system performs its intended functions accurately and reliably.
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 How AQS Can Help
Process Validation and Equipment Qualification
AQS' process validation consultants, provide straight forward high quality validation services for Process Systems and Equipment, Facilities, Utilities, Automation and Manufacturing Processes in the Pharmaceutical (Finished and Bulk), Biotechnology, and Medical Device & Diagnostic industries.
We have both the technical and personnel resources to provide validation work which meets or exceeds expectation, whether on a project basis or as personnel working under your direction. Our consultants can perform projects ranging in size from qualification of a single piece of equipment to complete turnkey validation of equipment, utilities, facilities, systems and processes of new facilities.
Automation & Controls Validation
Validating automation and control systems such as PLCs, SCADA (Supervisory Control and Data Acquisition), DCS (Distributed Control System), BAS (Building Automation System), and HVAC Systems, requires an in-depth technical knowledge of the systems along with validation expertise. Our consultants have the experience and skills needed to validate these complex systems.
Infrastructure Qualification Services
AQS' experienced team assists clients with the validation of enterprise-wide IT installations, including servers, mainframes, network hardware and applications. We provide regulated IT services necessary to design, implement, maintain and support all facets of an IT infrastructure including physical cabling, power, network connectivity devices, services, operating systems, applications, security and documentation.
Laboratory Systems Validation
AQS provides validation expertise in the areas of laboratory operations (R&D, QA/QC). From bench-top to LIMS, our services include equipment qualification and laboratory computer system validation, among others.
AQS' Expertise
AQS' consultants have extensive experience in validation and can offer a complete service in this area from development of master plans through to the development of process validation protocols. Services include:
- Develop Validation Master Plans (IQ, OQ , PQ )
- Review/approval of equipment and facility IQ/OQ
- Review/approval of process validation protocols
- Review/approval of test method validation
- Aseptic processing validation and personnel qualification
- Sterilization validation
- Water for Injection and Process Water validation
- Conduct pre-regulatory audit reviews
- Conduct 21 CFR Part 11 assessments on systems
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Computer Systems Validation
Computer Systems Validation (CSV) is a by-product of properly documenting the system requirements, standard operating procedures for operating and maintaining the system. CSV has become a major area of investment in the regulated industries.
How AQS Can Help
AQS offers complete life cycle validation services for computer systems. We have extensive experience with computerized systems used in manufacturing, quality assurance, document management, R&D, and clinical trials among others. We can validate systems prospectively or retrospectively, for off-the-shelf software, configurable software or custom designed software.
AQS' computer system validation and 21 CFR Part 11 services formally incorporate a risk-based approach to compliance as an integral part of the System Life Cycle to ensure compliance with regulatory requirements. AQS' consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts.
AQS' CSV services cover the full system life cycle, from requirements analysis through system retirement.
AQS' Expertise
AQS understands the complexities of computer system validation. We want our clients to learn about this process. Our services include:
- Develop Validation Master Plans
- Prepare User Requirements, System Configuration, Specification, and Design Documents
- Prepare computer system validation policies, procedures and work instructions
- Provide templates for pre-qualification and qualification documentation
- Perform vendor audits
- Develop and execute test protocols (IQ/OQ/PQ)
- Develop Validation Summary Report
- Conduct IS / IT Gap Analysis studies
AQS provides computer system validation services for all types of systems, from laboratory (LIMS), clinical and manufacturing systems for documentation control, process control, and record systems, among others.
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