In 1994, QPharma™ got its start as a computer system validation and consulting firm. More than 20 years later, our IT Compliance practice remains a core set of solutions and services within of our Professional Services division. From small projects and assessments, to major, long-term engagements and remediation efforts, QPharma has the resources and knowledge to deliver a total expert approach to IT compliance for life sciences.
Our personnel includes industry-leading experts on a continuum of IT services, including infrastructure qualification, policies, procedures, training, and assessments, as well as quality and compliance consulting.
Because QPharma focuses exclusively on the heavily regulated life sciences field, our team is staffed with top authorities on regulations imposed by FDA and other regulatory authorities affecting numerous industries, including pharmaceutical, medical device, bioltechnology, and animal health. We also provide solutions to companies that provide products and services to the life science industry, including compliance software developers, API manufacturers, contract laboratories, CROs, CSOs, and equipment manufacturers.
A Wide Range Of Services And Offerings:
- IT Compliance Planning
- IT Policies and Procedures
- IT Training
- Vendor Auditing
- Risk Assessment and Mitigation
- Infrastructure Qualification
- Validation Program Development and Planning
- 21 CFR Part 11 Consulting
- Project Management
Experts In Diverse Systems:
- Quality Management Software (CAPA, complaints, etc.)
- Content Management Systems
- Laboratory Information Systems
- SFA/CRM and Sample Accountability
- SaaS and Cloud-based Systems
- MES and ERP Systems
- … And Many More
To learn more about QPharma’s IT compliance expertise, please contact us.