Validation Services
Computer Systems Specification, Selection, Configuration & Implementation
Are you ready for an un-announced FDA inspection? To be protected from exposure to action by the FDA, Azzur can help your organization achieve & maintain a state of “audit readiness” at all times!
- Proof of Standards/Documentation
- Responding to FDA Questioning
- Employee Expectations
- Staff Training/Indoctrination
- Assessment of tools, techniques, controls
- Supplier/Vendor/Process Integrity/Audits
- React to Challenges
Azzur participates in the American Society of Quality (ASQ). Most of our SME’s have completed Auditor and Software Quality Engineering certificates
Commissioning & Qualification
- Commissioning
- Azzur offers a professional commissioning service through its strategic alliance with Genesis Engineers, Inc. Start-up and commissioning services include commissioning plan development, field execution activities through transfer. The work is executed by engineers who are Subject Matter Experts (SME’s) with technical experience specific to the industries that we serve.
We understand the importance of a well-documented and commissioned project and the effect it has on the project completion and successful validation.
- Commissioning Plans
- Enhanced Design Reviews
- Engineering/Design Resolution
- Factory Acceptance Tests (FATs)
- Pre-Functional + Functional Tests
- Project Management
- Protocol Development + Execution
- Start-up + Checklist Execution (link to GEI site)
- Training * Critical Spare Parts Evalution
- LEED Commissioning Projects
- Validation
- The FDA defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”
Our team of specialists are experts in providing documented evidence for our clients. We have experience in the following system life cycle documentation:
- User Requirement Specifications
- Functional Requirement Specifications
- Detailed Design Specifications
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Process Qualification
- Cleaning Validation
- SOPs
- Change Control
- Validation Services Overview:
Computer Systems Validation
From Project Managers to Validation Consultants, Azzur possesses in-depth experience in computer systems used in the Life Sciences. Quality Assurance needs are effectively achieved by combining technology expertise (SDLC) with regulatory knowledge; GXP’s, 510(k), GAMP, NCCLS, CLIA, Part 11, FDA etc.
- Master Validation Plans
- IQ,OQ,PQ
- Validation Summary Reports (VSR)
- Gap Analysis
- Remediation
- Project Mgmt.
- SOP Development
- URS
- FRS
- System Development/Configuration
- Implementation/Retirement Plans
- Change Control
- Vendor/System Selection
- Design Specs
- Templates
- Ongoing Maintenance/Upgrades
- Migration Plans
IT/IM Infrastructure
Azzur provides a risk based process for implementing an appropriate IT infrastructure (GAMP/ITIL) for supporting GXP compliant systems or replicated SOP’s… thereby reducing overall costs!
- Qualify & Standardize Hardware/Software Configurations
- Improve Performance
- Implement effective SOP’s / Controls
- Key Function Performance
- Validate Security
- Data Integrity
- Reduce IQ Testing & Validation Cost
Network Qualification
The objective of the network qualification is to implement effective procedures and controls, catalog and verify engineering documentation, demonstrate key function performance, validate security and data integrity, and demonstrate compliance to applicable federal regulations.
Azzur understands that a company must be compliant, but needs to keep their business running without overly restrictive procedures. We apply a common sense approach using risk analysis to determine where detailed procedures are needed, and where they are not. The IT environment is dynamic; and traditional qualification and validation practices are not easily applied.
It is Azzur’s strategy to qualify configurations of hardware and software that will be procedurally replicated within our client’s network infrastructure and have an impact on systems that require computer system validation. The resulting IQ testing of procedurally replicated network components, based on qualified configurations, can then be reduced.
We can provide assistance with all aspects of the Network Qualification process including:
- Project/Test Planning
- Specification & Design
- Implementation/Configuration
- Risk Assessment & Test Planning
- Qualification Protocol Development
- Maintenance
- Decommissioning
Lab/Clinical/R&D Systems
Lab Systems
Labs generate volumes of data; the reliability of this data must be assured! Whether interfacing with external applications (MRPII, ERP, etc.), performing Facility Commissioning, Instrument Qualification, Implementation, Configuration, or Validation, Azzur has a proven methodology that has been accepted worldwide.
HPLC, GC/LC, MS, TOC, NMR, FTIR, UV-Vis, Cell Counters, Dissolution, LIMS, Calorimeters, GammaCounters, Data Acquisition Systems, Batch Records
Beckman-Coulter, Labware, SAP QM, HP/Agilent, LabSys, LabVantage, ABI SQL*LIMS, Waters Millenium, Shimadzu, Applied Biosystems, Thermo, Sotek, Zymark, Tecan, Turbochrome
Clinical/R&D Systems
Regardless if you use an in-house system or rely on 3rd parties (CRO’s) to conduct your trials (I-IV), it is critical to confirm the accuracy, validity, and protection of traceable data. Azzur is a leader in Clinical Compliance and can handle entire turnkey systems validation projects…
- EDC
- Adverse Event Reporting (AERS)
- CDMS
- CAPA
- e-CRF’s
- e-510(k) Submittals
- Sales Force Automation
- Statistical Analysis
- Drug Safety Systems
- Pharmacovigilance
- Efficacy Tracking
- Protocol Management Systems
- Clinical Supplies
Documentum, ClinTrace, ClinTrial, Oracle Clinical, Aris-G, PhOSCo (IBM Clinware), PharmaTrace, eDE, eDM