Computer System Validation
We deliver a custom approach to computer system validation (CSV) and software quality assurance (SQA) for new validation programs or simply target areas of improvement with your current program.
Get Validation Help
We deliver a custom approach to computer system validation (CSV) and software quality assurance (SQA). We can deliver a new validation program or simply target those areas where you need additional help.
Our deep bench of Validation consultants have extensive pharmaceutical, biotech, medical device, and software industry experience. They provide leadership to companies seeking to meet FDA, EMA, MHRA, and other agency expectations.
Explore our Services:
- Validation Services
- CSV & CSA Programs
- Validation Process Improvement
- Equipment, Facilities, Utilities Qualification
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Validation Services
Validation Services
We can validate for you. Whether you are short on time or expertise, our experienced software validation project managers and engineers are available to get your validation project finished on time.
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CSV & CSA Programs
CSV & CSA Programs
Ensure the success of your validation projects… before you begin. Our consultants can help you implement a proven validation methodology and prepare your staff to use the latest computer system validation (CSV) and computer software assurance (CSA) techniques.
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Validation Process Improvement
Validation Process Improvement
If you know that your approach to software validation could be more efficient or more compliant, our consultants can help you identify process improvements and incorporate risk-based practices into your methodology.
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Equipment, Facilities, Utilities Qualification
Equipment, Facilities, Utilities Qualification
Know that your equipment is operating properly and that it meets both user and product-requirement specifications. Qualification testing provides you with this assurance.
Learn More about Equipment, Facilities, and Utilities Qualification
Validation Services
Whether you are short on time or expertise, we have the experienced software validation project managers and engineers who can get your validation project finished on time.
Our validation experts focus exclusively on your project – no distractions – to get the validation done quickly. We use the latest risk-based validation and computer system assurance (CSA) approaches, so you can start using your new system soon.
Or, if you have a legacy system that needs retrospective validation, our experts can promptly remediate the situation, so you don’t get caught in a state of non-compliance.
System validation projects can pose a significant challenge to employees who have other primary responsibilities. Projects can drag on for months – frustrating both the validation team and management.
Examples of computer systems we have validated:
- Clinical Trial Management Systems
IMPACT, Oracle Clinical, Aris LifeSphere, Intrinsic - Desktop Applications
Access databases, Excel spreadsheets, SharePoint sites - Digital Signature
AdobeSign, DocuSign, SignX, Assently E-Sign - Document Management Systems
Documentum, SharePoint, Veeva, ZenQMS, DOT.Compliance, LuciDocs - Electronic Data Capture (EDC)
Veeva CDMS, Medidata products - Enterprise Requirements Planning Systems
BPCS, JD Edwards, SAP, SYSPRO ERP, Microsoft Dynamics NAV - Electronic Trial Master File (eTMF)
Veeva eTMF - Infrastructure/VMWare
HP Enterprise Proliant/SimpliVity - Labeling and Inspection Software
Calypso, Docu-Proof, MeasureMind, - Laboratory Instrument Software
ChemStation, Empower, NuGenesis, Quadstar - Laboratory Information Management Systems
Applied Biosystems, STARLIMS, Thermo, LabDAQ - Learning Management Systems
ActiveLearner, IQS, ISOtrain, ZenQMS, Cornerstone, LuciDocs - Manufacturing Control Software
FANUC, MCC, PartMaker, PLCs - Manufacturing Execution Systems
Delta V - Medical Information
IRMS - Pharmacovigilance Systems
ARISg, Argus, Empirica Signal - Quality Management Systems
EtQ, IQS Quality Management, TrackWise - Serialization
Axway, TraceLink - Validation Management Systems
HP ALM, IBM Doors - Warehouse Management
SAP EWM
Our Approach to Computer System Validation Projects
We will ensure that your validation complies with FDA, EMA, MHRA, and other agency regulations:
- Our validation experts bring a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
- Perform system Risk Assessment
- Develop a Validation Plan that is appropriate for the system risk level and aligned with FDA CSA Guidelines
- Work with your team to document User Requirements and Functional Specifications
- Develop Test Plans and Deliver Validation Protocols (i.e., IQ, OQ, PQ)
- Execute the Validation Protocols and provide supporting test documentation
- Deliver inspections ready Test Summary and Validation Report
Outsource your next Validation Project or your entire Validation Program
Significantly reduce the timeline to a ‘validated state; We bring the methods, templates, and trained professionals Have the confidence that your validation documentation is inspection ready. Utilize your employees’ time to focus on what they do best, rather than struggling with CSV.
Our outsourcing experience includes Cloud-based, COTS, SaaS and Custom Applications:
- Cloud-based (SaaS and PaaS) applications
- Configured Off-the-Shelf (COTS) applications
- AI/ML applications
- On prem and cloud-based (IaaS) infrastructure
- Initial validation, retrospective validation, and ongoing validation for software updates