Qualification and
validation – fast and
from a single source

With Alegri, you can achieve US FDA and EU GxP compliance of computerized systems in the company quickly and efficiently.

From centrally managed and used systems all the way to the special systems used in laboratories, production, or clinical studies – Alegri’s risk-based and pragmatic approach provides security through audit compliance and advantages in the market. The Alegri process model is derived from the GAMP®5 guide and ensures that the specifications of both the European (EU GMP Annex 11) and American (US FDA 21 CFR Part 11) authorities are met.

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Our Service

The Alegri Process Model

The conditions and special requirements of the assignment in question and the resulting concrete regulatory specifications are taken into account.

  • Processes in the CompanyValidation master plan, processes and procedural instructions, management, and documentation
  • Qualification of the IT infrastructureSystem inventory/classification, integration of IT processes, involvement in audits, supplier management
  • Validation of applicationsProcesses and procedures for control, life cycle, documentation, supplier management

The Alegri Service Offer

Alegri’s extensive service offer provides support in all areas relevant to FDA/GxP.

  • Validation consultation according to GAMP® 5 for computerized systems with a focus on pragmatic approaches in order to achieve, maintain, and further develop compliance with FDA 21 CFR Part 11, EU GMP Annex 11.
  • Validation and qualification
  • Performance of supplier audits
  • Implementation and training
  • Validated system operation
  • Company-specific workshops

FDA-Compliant Document Management

The Alegri solution is based on Microsoft SharePoint and offers a document management system that is tailored specifically to the pharmaceutical industry and complies with the specifications of the FDA and 21 CFR Part 11.

  • Mapping of the entire document life cycle
  • based on the company-specific project organization
  • Implementation of complex search algorithms
  • Parallel processing of documents at different locations without needing multiple copies

SharePoint Solutions for the Regulated Environment

The Alegri solutions for the pharmaceutical and medical products industry are based on SharePoint, the requirements of FDA 21 CFR Part 11, and EU GMP Annex 11:

  • SOP Management
  • Packaging Management
  • Batch Record Management
  • Compliance and CAPA Management, etc.

Managed Services and the Cloud in a Regulated Environment

Alegri has many years of experience with regulation-relevant computerized systems in the field of complex IT infrastructures, in outsourcing and managed services, as well as the cloud area.

  • Analysis of the computerized systems in terms of outsourcing and cloud readiness.
  • Setup/implementation of a migration strategy to an outsourcing provider in due consideration of regulatory specifications
  • Setup/implementation of a migration strategy to a cloud service provider in due consideration of regulatory specifications

Your Advantages with Alegri

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Your partner with many years of experience

Alegri provides assistance by taking pragmatic approaches to achieving and maintaining compliance for the IT infrastructure and computerized systems in production, laboratories, and clinical research.

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Alegri Pharma Life Cycle Model

Development, introduction, and operation of validated systems. Connecting people, processes, and information. It’s fast, efficient, and pragmatic!

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Alegri has been audited

Alegri has been audited successfully multiple times by pharmaceutical and LifeScience companies.

The right path to the cloud in a regulated environment!

To find out about the essential aspects of the topic of the cloud in the pharmaceutical and medical technology sector, read the Alegri white paper on “Cloud Computing in the US/FDA and EU/GMP-Regulated Environment.”

Do you want to achieve compliance and security through audit compliance in a regulated environment?

Are you interested in using regulations to your company’s advantage?

Are you looking for a reliable and experienced partner?

– Alegri is your competent partner for achieving and maintaining FDA/GMP compliance.

Download free whitepaper now!

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