GxP Compliance

Our services include the Computer System Validation (CSV), Commissioning & Qualification (C&Q) of equipment and systems as well as internal quality management required in a GxP-regulated environment. In this way, we verify the suitability of purchased or self-developed software, commission and qualify the relevant IT infrastructure, systems and equipment.

While you concentrate on the essential tasks in IT, we take care of maintaining GxP compliance and act as compliance manager or quality manager. We also promote your compliance through internal audits and CAPA measures.

Legal requirements are forcing more and more industries to validate IT systems with an influence on product quality. Take advantage of our many years of experience in the validation of a wide range of complex computer-aided systems for your success: including ERP systems, Document Management Systems (DMS), Laboratory Information Management Systems (LIMS), IT service management systems and facility management systems.

Services:

• Creation of conceptual work for CSV processes
• Creation of validation master plans
• Coaching, planning and implementation of prospective validation projects including planning and test management
• Project quality management / document controlling
• Creation of CSV documentation (e.g. risk analyses, plans, test specifications, reports)
• Performance of the computer system validation
• Creation of as-built documentation
• Data integrity
• Revalidation
• Periodic review
• Training of the project team
• Training management within the project
• Audits of suppliers and service providers

Quality control (QC) is the most important control instance to ensure that medicines have the required properties. The properties to be checked, from active ingredient concentration and form to the correct DNA sequence, are just as varied as the laboratory equipment used for this purpose.

It is crucial that the laboratory equipment and supporting systems operate continuously and stably within the specified limits and tolerances and in accordance with GxP regulations. To ensure this, particular attention is paid to maintaining the qualification status.

We are happy to support you in ensuring that your laboratory equipment is ready for use in accordance with the applicable GxP guidelines. Our experienced consultants will support you throughout the entire life cycle, both during the initial qualification and during ongoing operation through periodic documentation reviews, audit trail reviews and the implementation of planned changes (change request documentation).

Services:

• Carrying out the initial laboratory equipment qualification
• Preparation of qualification documentation (e.g. risk analyses, plans, test specifications, reports)
• Implementation/management of qualification activities (IQ/OQ/ERES verifications)
• Creating and updating as-built documentation
• Periodic reviews to re-evaluate the qualification status (review of equipment documentation)
• Regular audit trail reviews
• Support in the planning and implementation of change requests
• Support and management of suppliers during the commissioning of laboratory equipment (calibration, IT settings, etc.)

The risk-based qualification of the IT infrastructure is an essential component of quality assurance in a regulated environment and required by law. A corresponding integrated qualification strategy avoids duplication of work in departments that access common IT services and provides consistent, qualified IT platforms. Here, too, the integration of the measures into a company-wide quality assurance system is crucial. Valcoba uses the V-model as its qualification strategy, whereby the time schedule and the phases and documents relevant for risk-based qualification are presented. You can also rely on us and our competent consultants for the qualification process.

Services:

• Creation of conceptual procedures and qualification plans
• Implementation of IT infrastructure qualifications
• Project management / document controlling
• Preparation of qualification documentation (e.g. risk analyses, plans, test specifications, reports)
• Creation of as-built documentation

Take care of your core business and leave the rest to us. Our experienced consultants will support you with efficient commissioning, qualification or validation activities and guarantee a punctual system handover for successful production. We guide our customers through the entire commissioning and qualification process of equipment and systems – naturally in compliance with all relevant guidelines and legal requirements (e.g. cGMP/ICH/21 CFR/ISO/ASTM) and through targeted quality management.

Services:

• Preparation of conceptual work for CQV procedures
• Project quality management / document controlling
• Preparation of C&QV documentation (e.g. risk analyses, plans, test specifications, reports)
• Implementation of qualifications and validations (equipment/systems, computer systems)
• Creation of qualification and validation master plans
• System and equipment qualification
• Creation of as-built documentation

Our teams of experts are well versed in all GxP areas and in quality assurance. Count on our support if you need to comply with regulatory requirements regarding cGMP activities through targeted quality management. We can also support you in the management of CAPAs or SOPs, in document creation for risk-based C&Q and validation or in routine production. You can also rely on us for training on GMP aspects, audits and supplier qualification.

Services:

• QA during the entire product life cycle
• Processing of compliance deviations, CAPAs and change management
• QA according to regulatory requirements and valid guidelines in the technical and operational area
• QA at the supplier side
• QA risk and gap analysis
• Periodic review and revalidations
• Compliance check
• Onboarding and training organisation (internal and external)
• Inspection preparation
• Mock auditing
• Process reengineering
• Creation of CSV procedures and CSV documentation
• CSV implementation
• Coaching, planning, implementation of projects
• Revalidation
• Trainings
• Audits