We Can Validate Your Computer Systems For You

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 experts can ensure your computer system validation (CSV) complies with FDA and international regulations.

We focus exclusively on your project – no distractions – to get the validation done quickly.

And, we use the latest risk-based validation approaches, so you can start using your new system soon.

Ask our experts to validate your system

We provided the CSV SOPs, CSV templates, and the validation experts to quickly validate the digital signature application.

Customer Success Story

A US pharmaceutical manufacturer had recently purchased licenses for a SaaS digital signature application. They wanted to start using the application for electronic signatures within GxP documents. However, they didn’t have in-house computer system validation expertise.

So, we provided the Computer System Validation SOPs, CSV deliverable templates, and the validation experts to quickly validate the digital signature application.

As a result, the company was able to quickly move from paper and ink approvals to electronic signatures for their GxP documents.

Need to validate your systems (out-sourced Validation)

We have over 20 years experience helping companies comply with FDA and international regulations.

Our team will:

  • Provide any Computer System Validation and Software Quality Assurance SOPs missing from your company QMS
  • Provide a suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
  • Perform a 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) and Requirements Trace Matrix (RTM)
  • Execute the Validation Protocols and provide supporting test documentation
  • Deliver inspections ready Test Summary and Validation Report

Our 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

We have validated the following systems:

  • Clinical Trial Management Systems:  Oracle Clinical, IMPACT
  • Desktop Applications:  Excel spreadsheets, Access databases, SharePoint sites
  • Digital Signature:  DocuSign, AdobeSign
  • Document Management Systems:  Documentum, SharePoint, Veeva
  • Electronic Data Capture (EDC): Medidata products
  • Enterprise Requirements Planning Systems:  SAP, JD Edwards, BPCS
  • Labeling and Inspection Software:  Calypso, MeasureMind, Docu-Proof
  • Laboratory Instrument Software:  Empower, NuGenesis, ChemStation, Quadstar
  • 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, EtQ
  • Serialization: Axway
  • Validation Management Systems:  HP ALM, IBM Doors

Ask Our Experts To Validate Your System

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Let's Talk Validation

+1 (847) 295-7160