Pharmaceutical Development

Product Support

  • Forming a link between client and machine supplier
  • Support of prototype development
  • Life-Cycle Management support

Scale-up-Support

  • Design transfer from test phase to production phase
  • Implementation of individual requirements

Process Support

  • Analysis of current process workflows
  • Establishment of GMP-conform process workflows
  • Interface Management

Compliance Support

  • Structuring of technical, process and quality management documentation
  • Qualification and validation of production- and control-plants and systems
  • GMP training of employees

Process-based Risk Management

Risk-Assessment

  • Establishment of a risk analysis strategy
  • Risk analysis of GMP plants
  • Risk analysis of computer systems

QbD-Assessment

  • Process development via the QbD approach that helps implementing ICH quality guidelines Q8 and Q9
  • Application of the QbD risk analysis as combination of probability
    and severity of the considered risk
  • Adaption to the relevant risk

Top-Down-Strategy

  • Analysis of existing process workflows
  • Establishment of a top-down risk management
  • Specification of problems

PQR – Product Quality Review

  • Refurbishment of existing data
  • Establishment of product quality review for easy process specifications verification

Quality Management

Qualification Support

  • Preparation of qualification documentation
  • Implementation of initial qualifications
  • Employees and plant qualification

Validation Support

  • Preparation of validation documentation
  • Validation of document management software
  • Validation of monitoring systems

Life-Cycle Management

  • Support of the prototype development
  • Support of the whole Life-Cycle Management process
  • Establishment of documentation software

Audits

  • Audit preparation
  • Audit execution

Project Management

Process Buildup

  • Buildup of new processes and operations
  • Analysis of existing processes
  • Expansion and reconstruction of existing processes

Project Management Assessment

  • Analysis of existing process workflows considering optimizing potentials
  • Planning of process optimization
  • Implementation of process optimization

Phase Conception

  • Demonstration of process phases
  • Structuring of process phases
  • Implemention of process phases

Digital Engineering

CAE – Computer Aided Engineering

  • Shorter development-cycles due to a focused information flow
  • Support and optimization of both new and established development processes
  • Planning and execution of quality assurance and quality management by computer aided measures

Paperless Data Management

  • Increased system efficiency
  • Reduction of working hours due to efficient data management
  • Support concerning document management and electronic filing

EDM – Engineering Data Management

  • Development and support of a client oriented data management system
  • Providing EDV expertise

SCM – Software

  • Configuration Management
    Versioning and conflict handling
  • Requirements maintenance

Data Migration

  • Data analysis in order to merge, replace or decommission systems
  • UseCase application to determine the best approach and assure a reliable data transfer
  • Development of Migration-tools, testing and validation planning and execution

2nd Level Support

  • Life-Cycle Management Application Support

Products

We continuously develop and engineer new and innovative solutions to optimize your processes and efficiency.

We are therefore pleased to introduce CVal to you.

CVal enables you a comprehensive, paperless qualification and validation of processes, plants and locations – combined in one application. With the object-based system you always have an overview of all relevant documents, attachments, interfaces as well as the mutual relationships and dependencies of the individual elements of the project.