Is your project losing ground?
Is your project losing ground?
Let it be managed by a certified and professional Project Manager
Are your GxP IT Systems in compliance?
Are your GxP IT Systems in compliance?
Get an audit assessment to see where you stand

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.
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Does your project need a jumpstart?

Start making progress and reach Go Live! with a certified Project Manager

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Services

Project Management

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!

GxP Compliance

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.

IT & OT Management

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.

Audits and Assessments

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

Cristian Bogdan Dragomir

Owner & Senior Project Manager
MSc. E.Eng. | PRINCE2 | COBIT5 | SAFe4 | GAMP5

See full CV

Zheni Nikolaeva Dimitrova

Zheni Nikolaeva Dimitrova

Junior IT Consultant
Software architecture | Cloud Services | Project Management

See full CV

19

Projects delivered

23

MDKK as total budgets managed

22

IT Systems and applications deployed

Portfolio

Inspection Readiness

Article coming up soon!

Automatic Visual Inspection Integration

Article coming up soon!

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Reach out

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

E-mail: contact@alphaworkflows.com

Address: Lysefjordsgade 4, st. tv. 2300 Copenhagen

CVR: 39518783

REG. NR. 2878 KONTONR. 6897620012

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