Quality Managementand Enterprise Content Management (ECM) are an integral part of pharmaceutical companies by managing digital content throughout the organization to support business processes and regulatory compliance.
The challenges in quality management are numerous: stringent regulations, complex supply chains, the need for consistent product quality and patient safety, but also issues inglobal collaboration. Compliance with GxP standards, data security, and scalability are a “must”. Equally important are ensuring supply chain integrity, implementing advanced technology, maintaining data integrity, and aligning ECM with quality management. Robust quality control, risk management, and change control processes help to prevent defects and comply with regulations.
Therefore, investment in quality systems and personnel training pays off when it comes to meeting high standards of product safety and efficacy while navigating the complexities of the pharmaceutical industry.
Epista Life Sciences provides an array of services for life science firms, with a focus on Quality Management Systems and Enterprise Content Management (ECM) in the quality sector. Our solutions are crafted to assist organizations in navigating through digital transformation complexities, ensuring regulatory compliance, and improving operational efficiency.
As an end-to-end Business & Implementation partner, we specialize in providing comprehensive services assisting life science organizations in turning business strategy and goals into actionable decisions.
This is what we offer:
Epista is a Veeva Preferred Services Partner
Accelerators:
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Our dedicated team of experienced life science consultants works closely with clients across all geographical areas to develop strategic IT roadmaps aligned with their business objectives. We offer expert guidance on leveraging solutions to enhance collaboration, streamline workflows, build scalability, and ensure compliance with industry regulations.
Our services include:
From the initial stages of project preparation, through implementation and configuration, to the ongoing operations & maintenance support, our committed team offers comprehensive assistance throughout the entire journey. We aim to facilitate a seamless transition to the platform and maximize its value to your organization.
IT System Implementation services include:
During this initial phase, we work closely with your team to lay theground work for a successful implementation.
Key activities include: Scope definition, resource planning, business preparation, and project governance.
As your trusted business partner, we take on the responsibility oftranslating your business requirements into technical terms, ensuring that the system setup contributes long-term value to your organization. Our certified and experienced consultants serve as a bridge between you and the IT vendor, guiding you through decision-making processes, explaining various options alongwith their consequences and implications, and ultimately providing recommendations tailored to your specific needs.
Validation is a critical phase to ensure that the implemented ECM solution meets regulatory requirements and organizational standards. But for SaaS solutions it is way more than that: the right validation strategy will ensure that you can efficiently maintain the validated state of yourapplication throughout the frequent system releases.
Driving user adoption is crucial for the success of any ECMS implementation. We support business adoption through training, change management, communication and stakeholder engagement.
Upon successful completion of the implementation project, we ensurea seamless handover to the Operations & Maintenance teams. Our handover services include detailed documentation, knowledge transfer, and ongoingsupport to ensure a smooth transition to your operations and maintenance teams.
Focus on your core business activities with confidence! We offer you to fully outsource your SaaS operation & maintenance. Our Managed Operations encompass daily system administration, error and incident management, release management, as well as change management to drive innovation and improve your IT solution based on continuously evolving business needs.
These services include:
Our technical services encompass a wide range of offerings aimed at maximizing the functionality and efficiency of ECMS solutions.
These services include:
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.
