2019 Regulatory Training Sessions

Receive the same training as the US FDA Consumer Safety Officers

Data Integrity | Computer Validation | Software as a Medical Device

Cloud Compliance

Click here for 2019 Training Content Details

CompliancePath customers benefit from a cooperative model that eliminates the need to maintain  costly internal validation resources. We provide a plug-and-play EU/FDA GxP IT compliance program that significantly reduces costs and most importantly, enables customers to maintain the focus of funding and resources on their core competencies.

  • Compliance/ Validation/ Quality as a Service
  • Compliance as a service delivery to meet your company requirements
  • Cost efficient and transparent
  • Plug-and-play compliance with monthly fixed costs

Our commitment is to maximising your ROI by having your
chosen systems up and running, fully validated and fully
compliant: quickly, efficiently and cost-effectively

  • Computer System Validation
  • Risk assessments
  • Infrastructure and cloud
  • Qualification
  • Validation planning and qualification
  • Creation of Validation Accelerator Packs

Choosing CompliancePath as an independent validation partner means that the conversion from first customer inquiry to satisfied systembuser is greatly accelerated.

  • Increase additional revenue through validation partnership
  • Decrease sales cycle
  • Increase sales conversion rate
  • Complete cycle and now offer customers end-to-end solution

‘SCOTsourcing’

  • Low labour rates
  • Highly qualified
  • English speaking
  • Life science experience
  • Low attrition rates
  • Shift Matching – All US Timezones

COMPLIANCE POLICIES

Following industry and regulatory expectation, our team can customise one, two or a whole suite of IT/ SQA compliance procedures and policies to ensure that your company is in line with the NHS directives, EU Vol.4 Annex 11, ISO13485, ISO14971, IEC62304, US 21 CFR Parts(s) 11,210,211, 820, HIPAA & HITECH

The CompliancePath team was active in the revision of ISPE’s GAMP IT Infrastructure Control and Compliance Guide for the Cloud and SaaS deliveries.

IT AND DATA INTEGRITY AUDITING

Our senior audit team carries ISACAs coveted CISA & CRISC designation and has performed Data integrity training directly to the US FDA.

Our Data Integrity Assessment process can quickly identify gaps in your regulated data governance processes.