CASE STUDY
A digital marketing and technology company selected RCM to assess their validation and compliance methods in relationship to the new FDA Computer Software Assurance (CSA) Guidance.
OBJECTIVE
A Pharmaceutical startup company commissioned RCM to develop their policies and standard operating procedures (SOP) to establish overall company governance and general data protection requirements (GDPR).
Develop Governance Policies and SOPs to comply with FDA and EMEA regulations.
SOLUTION
- Performed an assessment and prioritized the work based on essential Policies and SOP required to meet FDA guideline
- Worked with “C” level members to develop the Policies and SOP for overall Governance and General Data Protection Regulations (GDPR).
- Reviewed all documents with Legal to ensure accuracy of policy language; reviewed all documents with Corporate team to ensure documents complied with FDA and EMEA.
RESULTS
- Developed the essential set of corporate governance policies and researched the data protection regulations for both US and EMEA to assist in the development of a comprehensive data protection SOP.
- Leveraged RCM’s proprietary library to furthering the strategic direction of the company for ongoing maintenance of corporate documents over time.
- Assisted with establishing a training education program to train employees on corporate policies and GDPR.
- Performed this work over a period of 18 months and provided project management to manage and track all new documents in the company Quality Document Management System (QDMS).
Key Project Elements
Entire organizational impact
Address US and EMEA regulations
Established Training and Education Program
Used the QMS system for all document creation and reviews.