About the company
In a nutshell
Alpha Workflows is a consultancy company addressing needs for the pharma and medical sectors, but not exclusively. It provides services within and across three domains: Project Management, GxP Compliance and Governance & Management of IT & OT. Integrity, commitment and partnership are the core values behind the services offered and they are rooted in the experience and way of working within highly regulated environments.
Does your project need a jumpstart?
Start making progress and reach Go Live! with a certified Project Manager
The service where certifications and partnership meet! Let your projects be managed by a certified (PRINCE2, SAFe4) and passionate professional for navigating your project through all the stages. From business case definition and project initiation to handover and project closure. Leverage coaching of your stakeholders in a true partnership service which ensures Go Live! On time, on budget, on quality!
Are you seeking to deploy a GxP compliant solution? Unsure which quality strategy fits best your system and business processes? Ensure that your systems have the right level of quality based on GAMP5 and establish compliance for your IT & OT following a risk based approach and in line with your QMS. Reach out for a discussion about how to safeguard the compliance of your GxP systems.
Are you looking into a new IT implementation, an upgrade or migration? Is your department struggling with operating & maintaining IT? Do you want best practices for ensuring that your next Manufacturing IT solution will actually enable business value? Then reach out for a discussion about your opportunities for IT & OT governance and management based on the COBIT5 framework.
Are you in doubt whether your GxP systems are ready for the next inspection from the Authorities? Are you complying with all the 21 CFR Part 11 requirements and are you following GAMP? Find out where you stand, determine compliance gaps and act on mitigating actions timely, before the inspection! Alternatively, reach out for post inspection follow-up to determine the corrective actions.
Behind the company
Cristian Bogdan Dragomir
Owner & Senior Project Manager
MSc. E.Eng. | PRINCE2 | COBIT5 | SAFe4 | GAMP5
Zheni Nikolaeva Dimitrova
Junior IT Consultant
Software architecture | Cloud Services | Project Management
MDKK as total budgets managed
IT Systems and applications deployed
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If you are interested in finding out how your projects can be better managed, ensuring GxP compliance and discussing governance and management of your IT & OT then please reach out. We can arrange an unconditional meeting and discuss about your needs and the opportunities for addressing them.
Or feel free to reach out for any other inquiries.
Phone: (+45) 23413355
Address: Reventlowsgade 8, 3. 1651 Copenhagen
REG. NR. 2878 KONTONR. 6897620012