Business Applications Management

Ensuring Continuous Compliance in Business Applications

Navigating the complexities of the evolving Business Applications landscape: As we increasingly rely on diverse Cloud applications and require business information to be available anytime and anywhere to drive round-the-clock global operations, the business applications landscape becomes more intricate. Ensuring compliance of the business applications architecture whilst maintaining cost effectiveness and efficiency is crucial for life sciences companies.

This entails effectively managing business applications and establishing an operational setup that ensures consistent compliance with regulatory requirements.

Here's how to achieve this:

  • Comprehensive ERP Management: Implement a robust strategy for managing your ERP     system. This involves regular updates, customization to suit industry-specific needs, and thorough documentation of processes.
  • Adherence to Regulatory Standards: Stay abreast of evolving regulatory requirements within the life sciences sector. Align your business applications with these standards to ensure compliance at all times.
  • Streamlined Operations: Build an operational setup that prioritizes compliance without compromising efficiency. Utilize automation and data analytics tools to streamline processes while maintaining adherence to regulations.
  • Continuous Monitoring and Evaluation: Establish protocols for ongoing monitoring and evaluation of your ERP system and operational setup. This proactive approach allows for timely identification and resolution of compliance issues.
  • Employee Training and Awareness: Invest in training programs to educate staff on compliance protocols and best practices. Foster a culture of compliance where every team member understands their role in maintaining regulatory adherence.
  • Collaboration with Compliance Experts: Engage with compliance experts within your     organization or seek external partnerships to enhance your understanding of regulatory requirements and optimize your ERP setup accordingly.
  • Audits and Reviews: Conduct regular audits of your ERP system and operational processes to identify areas for improvement. Use feedback from audits to refine your compliance strategies and ensure continuous enhancement.

By prioritizing compliance in business application management and operational setup, life sciences companies can uphold regulatory standards while driving efficiency and innovation in their organizations.

Epista Services - From Implementation to Operations

Epista’s comprehensive approach encompasses every aspect of the digitalization journey from management advisoryto IT strategy, solutions design, and setting up efficient and compliant operations, regardless of Cloud or on-premise applications. Our services cover the entire life cycle from product and partner selection, implementation, and ongoing operations. With a wealth of experience in handling GxP critical data, systems and documentation, particularly in ERP systems and business applications such as SAP and Microsoft Dynamics 365, MES (ManufacturingExecution System), LIMS (Laboratory Information Management System), QMS (Quality Management System), and data integration solutions, Epista is uniquely positioned to support organizations in meeting regulatory requirements while optimizing efficiency.


The business benefits:
  • Robust ERP and business operations
  •  “Always compliant” operations
  • Seamless and fast change-over from legacy systems to new solutions
  • Significant reduction of downtimes
Talk to an expert
Lasse Bruhn
SVP, Managed Operations & ERP

Project Preparation

Our services empower life sciences companies to make informed decisions, anticipate consequences, and strategize effectively. We provide expert management advisory to ensure the selection of optimal platforms and partners. Our team's support prepares organizations for their journey, encompassing overall business strategy, solutions design, and compliance and validation services.

Search and Selection

  • Business needs assessment
  • IT System selection
  • IT Supplier selection
  • Enterprise Architecture

Organization Readiness Assessment

  • Gap/Fit analysis: IT QMS assessment
  • Validation Strategy
  • Identifying and mitigating potential risks

Operational Excellence & Compliance

  • Align & improve IT admin. procedures, define SOPs
  • Establish Operational Governance
  • Align IT and QA processes

IT Supplier Assessment

  • IT Supplier Assessment / Qualification
  • Cloud Qualification

Validation Planning & Initiation

  • System Validation Plan
  • Validation activity planning

Defining & Optimizing Processes, Procedures & Tools

  • Tools support for processes
  • Azure DevOps Configuration
  • Project Quality Handbook

Business Process & Requirement Specification Support

...and more.

Business Applications Implementation

Preparing for the implementation of business applications begins with understanding the intricacies of operating the solutions. Among these, ERP systems often pose the greatest complexity in transitions. Hence, we place our trust in established governance practices to support both customers and implementation partners.

Solution Design

  • Enterprise Architecture services
  • Project preparation (e.g., test & validation strategy)

Validation Management & Execution

  • Business process & requirement assessment
  • System specification activities
  • System verification activities
  • Traceability Matrix
  • Quality Control of validation activities
  • Validation Report
  • Validation Documentation Templates

Program and Project Management

Operations preparation

  • Responsibility matrix
  • Operations Quality Handbook
  • Updates/creation of SOPs

...and more.


In the realm of life sciences, maintaining control over a cloud solution requires coordination across various roles - from business stakeholders to QA, partners, support teams, and data management experts. This multifaceted task demands constant adaptation to the evolving landscape of business and IT solutions.

Ensuring compliance and validation remains an ongoing endeavor, extending far beyond the initial implementation phase, particularly in our increasingly digitalized environment. While the cloud offers efficiencies, it also introduces challenges such as forced updates and releases. However, with the right expertise, these updates can enhance system performance.

VaaS (Validation as a Service)

  • Change, Release, & Test Validation& Coordination
  • Service Delivery Management
  • Change and release management
  • Periodic Reviews

...and more.

Why? In the dynamic realm of life sciences, the regulatory landscape is constantly evolving, necessitating software and systems that can adapt swiftly to support business transformation. Mandatory updates are a given for IT systems.

What? Our approach entails a pre-planned lifecycle, from approved changes through implementation to production. This involves orchestrating compliance and digitalization efforts within the organization.

How? We achieve this through meticulous coordination and planning, consolidating input from developers, operations, and projects into a unified release calendar. This calendar factors in timelines, goals, and resources to ensure seamless execution. Furthermore, we ensure that requisite documentation of process execution is in place, serving as a vital resource for auditing purposes.

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We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.