Validation OutsourcingWhether 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 computer system complies with FDA and international 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

By leveraging our experience, you can:

  • Significantly shorten the timeline to a “validated state”
  • 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 systems – SaaS, PaaS, IaaS
  • Configured Off-the-Shelf (COTS) packages
  • Custom build systems and applications
  • Network qualification
  • Infrastructure and server qualification

Examples of computer systems we have validated:

  • Clinical Trial Management Systems:  Oracle Clinical, IMPACT
  • Desktop Applications:  Excel spreadsheets, Access databases, SharePoint sites
  • Digital Signature:  DocuSign, Adobe eSign
  • Document Management Systems:  Documentum, SharePoint, Veeva
  • Enterprise Requirements Planning Systems:  SAP, JD Edwards, BPCS
  • Labeling and Inspection Software:  Calypso, MeasureMind, Docu-Proof
  • Laboratory Instrument Software:  Empower, NuGenesis, ChemStation
  • Laboratory Information Management Systems:  STARLIMS, Applied Biosystems, Thermo
  • Learning Management Systems:  ISOtrain, ActiveLearner, IQS
  • Manufacturing Control Software:  FANUC, PartMaker, MCC, PLCs
  • Manufacturing Execution Systems:  Delta V
  • Medical Information: IRMS
  • Pharmacovigilance Systems:  ARISg, Argus, Empirica Signal
  • Quality Management Systems:  TrackWise, IQS Quality Management
  • Serialization: Axway
  • Validation Management Systems:  HP ALM, IBM Doors

Outsource your Computer System Validation Project