Serialization Epista Life Science Consultancy

Serialization

Are you ready to comply with Serialization regulations by the 2017 deadline in the US, or the 2019 deadline in Europe?

A successful implementation of Serialization requires attention from almost every department in your organization: legal, IT, sales/marketing, sourcing, supply chain, quality, regulatory, and manufacturing. They all have to be involved, driving a mutual effort to a successful program implementation. Is your company facing difficulties gaining control of your Serialization program? Do you have the necessary knowledge, experience, and resources available? The key is balancing the right level of compliance and quality, while still being able to control your overall expenses. 

Epista can help you get in control - from strategy to execution and validation. Our pragmatic approach will help you figure out where you are now and where you need to go. Our subject matter experts can provide concrete, useful advice on how to get your Serialization program implemented before the rapidly approaching deadlines. 

Ask us about our services:

- Health Check of existing Serialization Program. Evaluations, overview, and well-being of the current Serialization Program. The key objective of the Serialization Health Check is to verify readiness, identify challenge areas, and specify technical requirements.
- Strategic Advisory Services. Providing strategic services customized to client needs, including strategy workshops, budget overview, organizational design and staffing, pilot project and rollout plan, and more.
- Selection of best fit for purpose IT vendor. Applying proven methodologies for IT vendor selection including the following steps: pre-analysis, business case, process scoping, definition of overall requirements, vendor short-list review, product demo and vendor selection, support through contract negotiation.
- Project, Program, and Quality Management. Providing a comprehensive set of proven project management and quality management methodologies that enable us to guide and assist pharmaceutical companies in successfull implementing their Serialization program.
- Compliance Support and IT Consultancy. Highly qualified IT and compliance specialists ready to advise and assist your team in complying critical IT systems with the setup adn goals of the Serialization program.
- Validation of equipment and IT systems. Definition and execution of the overall validation strategy and validation plan, and ensuring the right level of documentation throughout the process.
- Efficiency Tracking: OEE Tracker. Improving the overall equipment effectiveness of pharmaceutical packaging and manufacturing lines in a cost-effective, expedited way. 

Check out our latest webinars on Serialization:
Roadmap to Compliance from a Quality Perspective
Kick-start your Serialization program

Get in touch. We enjoy sharing our knowledge and are happy to discuss advancing regulatory compliance in your company:

Phone: +45 4825 4500
General Info: info@epista.com
Sales Team: sales@epista.com
Services Team: services@epista.com

Epista Life Science
Get in touch: Need help to understand and conform to new regulations? Change your IT landscape? Find and achieve the appropriate compliance level in your organization? Whatever your needs, Epista can help