2019 Regulatory Training Topics
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
- 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
- Low labour rates
- Highly qualified
- English speaking
- Life science experience
- Low attrition rates
- Shift Matching – All US Timezones
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.