Sipe Consulting: Expert support
Pharmaceutical innovations

We express our sincere appreciation and gratitude for the effective collaboration in the field of computerized systems validation. SIPE Consulting approaches each project individually and responsibly, consistently demonstrating a high level of professional expertise.

These days, the term Data Integrity is no longer a surprise to drug manufacturers. However, in 2016, when our Company, first encountered the requirement for a system that guaranteed data integrity (as part of an audit by a contract partner), things were more complex.
The complexity of this requirement became apparent as we delved deeper into regulatory documents, cross-referenced the data, and studied our partners' experiences. To professionally assess the situation as is, we decided to engage experts in 2019. The contract was signed with the company whose scope of work and services included comprehensive data integrity assessments at the enterprise. One of the experts was Yuriy Sandler, then the Managing Director of the contracted company. His responsibilities included auditing laboratory and general computerized systems, as well as reviewing documentation for the qualification and validation of all systems.
This was an extremely interesting and rewarding experience. Employees from all departments of our company had the opportunity to gain real-world knowledge and understanding of the scope of data integrity requirements for all processes during this project.
The project resulted in a detailed report covering all areas and a CAPA plan. Undoubtedly, many problems are difficult to resolve due to a lack of technical capabilities. Technological and laboratory equipment from various acquisition periods was missing, for example, essential computerized system functions such as an audit trail. During the project and report approval process, POLYSAN team received helpful and professional advice from Yuriy Sandler on resolving these issues.
The project resulted in a detailed report covering all areas and a CAPA plan. Undoubtedly, many problems are difficult to resolve due to a lack of technical capabilities. Technological and laboratory equipment from various acquisition periods was missing, for example, essential computerized system functions such as an audit trail. During the project and report approval process, POLYSAN team received helpful and professional advice from Yuriy Sandler on resolving these issues.
Advisory support continued after the Project's completion. Our Company always strives to participate in training events where Yuriy Sandler addresses issues, as we value him as a leading expert in the field of computerized systems and Data Integrity. We are currently working on a new direction – Quality by Design – which we consider essential for our Company.

AKADEMPHARM, thanks Sipe Consulting, represented by Yuriy Sandler, for the assessment of our Company's IT infrastructure and data integrity. During the assessment, Yuriy thoroughly answered all employee's questions regarding management, validation, risk assessment of computerized systems, IT infrastructure management, and data integrity, as well as explained modern approaches. The assessment was guided by current international requirements and recommendations in this area.
The report was submitted promptly and in a timely manner. It included a description of the IT infrastructure, a register of computerized systems with a risk assessment, and a CAPA plan with recommended action deadlines. During the CAPA plan implementation, new questions arose, and Yuriy was always ready to provide detailed answers and suggested solutions.
AKADEMPHARM, State-Owned Enterprise, distinguishes Yuriy Aleksandrovich Sandler as a highly qualified specialist and expert in IT infrastructure management, computerized systems, and data integrity.
We look forward to continued cooperation.

KISLOROD, LLC, thanks Sipe Consulting, in particular Lyudmila Shitova, Director of the Drug Authorization Department, and Alyona Sidorenko, Sales Director, for the prompt evaluation and revision of documents for the authorization of medical oxygen, as well as the individual approach to the project payment. It is always a pleasure to work with the reasonable, intelligent, and tolerant people who work at Sipe Consulting. I wish Sipe Consulting development and prosperity in the vast pharmaceutical market. I personally recommend working with Sipe Consulting to my colleagues; positive results will not be long in coming.
I wish my colleagues the chance to meet more professionals like those at Sipe Consulting. It was a pleasure working with you! Thank you so much!

I would like to express my gratitude to Sipe Consulting, represented by Yuriy Aleksandrovich Sandler, its General Director, and Anastasia T., Leading Expert in Drug Authorization, for their fruitful work and to commend their high performance and professionalism. Your unique approach and creativity have helped optimize our productivity. You exemplify integrity and professionalism!