General Consulting Services

At Epista, we offer consulting services across areas of Life Science. From regulatory to clinical to production and everything in between, we have been dedicated to Life Science since our founding in 2009. Our subject-matter-experts work at the intersection of compliance and business to help you continuously improve to achieve more. Our consulting services cover the areas of Quality and QMS, Compliance, Security, Project Management, Remote Audits, and more. Learn more below:

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Quality & QMS

Within quality and quality management, Epista consultants can fill a variety of gaps in your business including:

  • Qualified Person (QP)
  • Responsible Person (distribution of pharmaceuticals)
  • Person Responsible for Regulatory Compliance (PRRC)
  • Department QA/QC manager
  • Quality Engineer (e.g., complaint investigations, risk evaluations, change & deviation management, etc.)
  • Analysis & Reporting (PQR/QPR, elemental impurities, residual solvents, etc.)
  • QMS development and maintence
  • Outsourcing of other QMS areas and activities

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Compliance

As experts at the intersection of compliance and business, our team has a wide array of knowledge across compliance areas including:

Audits

EU/US GMP, GDP, & Medical Devices

  • Suppliers, laboratories, internal QA/QC departments, CMO/CRO
  • Distributors, re-packers, pharmaceutical transport companies
  • EU GMP, EU GDP, MDD/MDR, ISO 13485, 21 CFR 820, 21 CFR 210/211
  • IT processes, IT departments, software development processes
  • Due diligence QMS processes

QMS

Gap analysis, establishment, reconstruction, extension of QMS systems

  • EU GMP, GDP, MDD/MDR, ISO 13485, 21 CFR 820, 21 CFR 210, and other regulatory requirements

Validation & Qualification

  • Manufacturing, laboratories, administrative services, HVAC, etc.

Serialization & Aggregation

  • Services related to clean rooms/sterile environments

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Security

Security is an important building block for Life Science companies. That is why our experts have deep understanding of security requirements for the Life Science industry. Our expertise covers:

Records & Information Mangement (RIM)

  • Routines for regulatory and business critical information

Data Integrity

GDPR

  • GDPR framework establishment
  • GAP analysis / GDPR process improvement

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Project Management

Regardless of the IT system or area of expertise, Epista's consultants have the knowledge to lead your proejcts from system introduction and implementation through Product Life Cycle Management (PLM).

IT System Introduction & Implementation

  • SAP
  • Movex
  • Dynamics 365
  • Veeva
  • LIMS
  • EBR Systems
  • Serialization & aggregation systems
  • And more

Product Life Cycle Management

  • Initial conception
  • Design control (R&D)
  • Industrialization
  • Product care
  • Product decommisioning

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Remote Audits

Why remote audits? According to current regulations, supplier arudits are needed as a part of the supplier qualification. Sometimes, these audits cannot be performed on-site. We solve this with remote, paper-based audits (distant assessment) where certain parts of the audit are performed via a web meeting.  

We have developed a "best practice" on how a remote audit can be done.

  1. A risk assessment is performed in collaboration with the customer to evaluate priorities.
  2. A detailed audit plan is prepared and sent to the supplier to ensure that they have the right people and necessary technical equipment.
  3. The remote audit is conducted based on the risk assessment and the documents obtained from the supplier before the audit.
  4. An audit report is compiled, and the risk analysis is updated with the results of the audit. An assessment is made of whether a subsequent on-site audit is needed.

If an on-site audit is considered necessary, it will be done in areas that could not be inspected during the remote audit. This means that this will be a shorter audit focusing on the areas that need further review according to the risk analysis.

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We also offer consulting services across the IT system life cycle. Learn more about those services here.

If your business could benefit from any of above services, or even something else, please get in contact and we will help you find the solution that is best for you.