IT Quality, Compliance, and Security
Owning your data is the fundamental backbone of any life science company. It is of the utmost importance for pharmaceutical manufacturing companies to have the strictest controls over the Intellectual Property (IP) of their drug product. The quality and security of this data, along with its compliance with industry regulatory requirements is paramount.
Our IT Quality, Compliance, and Security experts help you reduce risk, maximize security, and preserve data integrity. As pharma industry specialists, our consultants boast skillsets in both technical IT and regulatory requirements. Additionally, they are backed by a robust set of systems to support clients effectively and efficiently in quality, compliance, and security.
Pharma IT/PLG supports pharmaceutical manufacturing clients with the following services:
- Computer System Validation (CSV): We perform validation projects to ensure that the client’s software or system performs as intended. Our consultants are certified in CISSP, CISA, GDPR, CISM, ISO 27001, GAMP, EU Annex 11, and more. We are also experts in the V-model, Quality in Data Migration, User Requirement Specifications (URS), System Management SOPs, and much more.
- Qualification of Infrastructure: We have experienced consultants who can ensure your laboratory and manufacturing facilities are GMP compliant by qualifying your IT Infrastructure. Pharma IT can help you design, build, qualify, and execute an IT infrastructure solution that is reasonable, secure, risk-mitigated, compliant, and tailored to your needs.
- Data Integrity: Our consultants are data integrity experts with several years of experience in the field and can assist you in establishing a sound data integrity practice. With grounding in the ALCOA++ principles, we can provide gap analyses, training, Policy and SOP development, mapping of processes and systems, and process optimization.
- Data Protection Officer: This is a specific role where the expert consultant is responsible for protecting your data and ensuring EU-GDPR compliance. They work on data mapping, gap analysis, and enhancing the security of your data. This includes ensuring general risk management through the appropriate technical and organizational measures, executing recurring training & internal audits, cooperating with supervisory authorities, and monitoring regulatory developments to ensure compliance.
- Security Management: This entails a list of services inclusive of, but not limited to Risk Assessment, Business Impact Assessment, Data Privacy Impact Assessment, Software Vendor Audit, and Cybersecurity Program Acceleration Assistance.
Why Choose Us as a Pharmaceutical Industry Security Partner
EXPERTS
Pharma IT’s experts have the knowledge and experience working in the IT and Regulatory fields to support clients with multiple services in Quality and Security services. Coupled with PLG’s global footprint and extensive resources, we can assist your company in a host of geographies.
AGILITY AND FLEXIBILITY
Pharma IT has systems already designed and running to ensure your data is well protected while remaining compliant. We also cater to your specific needs to the unique nature of how you would like to manage your data.
SCALABILITY
Pharma IT/PLG considers both your current, and future security needs by designing systems that can grow alongside your company. We believe in the longevity of our designs to maintain consistency as a hallmark of greatness.