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, CQV 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

CQV participates in the American Society of Quality (ASQ). Most of our SME’s have completed Auditor and Software Quality Engineering certificates

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Computer Systems Validation

From Project Managers to Validation Consultants, CQV 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

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IT/IM Infrastructure

CQV 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.

CQV 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 CQV’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

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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, CQV 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. CQV 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

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Commissioning & Qualification

Instructor-Led 1/2 Day, 1 Day, or 3 Day Compliance Training

CQV keeps pulse of the changing FDA guidelines & are experts in worldwide training of regulatory issues and trends. Utilizing a Best-Practice Approach, CQV has created a suite of programs that assure Quality Improvement & ROI.

• Tailored /Company Specific Training
• Executive Awareness Courses
• Internal Process / SOP’s
• Introductory to Advanced
• ‘How-to’ Courses
• BPI/ Six Sigma
• Train the Trainer
• Quality Coaches
• Knowledge Transfer/Retention

Reach Large Geographies with our Web-based or CD-ROM Technology

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