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.
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.
Our validation experts focus exclusively on your project – no distractions – to get the validation done quickly. We use the latest risk-based validation 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.
Let us validate your system for you
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
- 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
Our validation professionals can work with you either at your site or remotely – whichever fits your needs and budget.
Outsource your next Validation Project or your entire Validation Program
By leveraging our experience, you can:
- 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)
- On prem and cloud-based (IaaS) infrastructure
- Initial validation, retrospective validation, and ongoing validation for software updates
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
Outsource your Computer System Validation Project
