WIL-Zone
Consultancy Office

For our partners operating computerized systems under pharmaceutical regulation (DMS, ERP, WMS, QMS, MES, CDS, LIMS, EMS, etc.), we recommend performing a data integrity assessment appropriate to the criticality and complexity of the system, according to EU GMP Annex 11 and 21 CFR Part 11 requirements, as well as carrying out or supporting computerized system validation.

During computerized system validation, we follow the pharmaceutical validation practice of Computerized System Validation and apply the guidance of the second edition of GAMP5 (GAMP5 SE), while also following pharmaceutical terminology (GxP IT - IQ, OQ, PQ).

We support compliance with pharmaceutical regulations by developing documentation systems that meet Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP) requirements, reviewing existing quality assurance systems, and performing audits that help prepare for authority inspections (OGYÉI, NÉBIH, FDA).

We provide consultancy for building and improving management systems according to ISO 9001, 14001, 27001 and other standards. We support the operation of existing systems by performing internal audits and assisting with quality planning and management reviews.

We build management systems for testing and calibration laboratories according to ISO 17025, medical laboratories according to ISO 15189 and biobanks according to ISO 20387, and support preparation for authority accreditation assessments. We also support existing systems by performing internal audits and assisting with quality planning and management reviews.

Risk analysis is the identification, grouping and evaluation of possible risks in a risk management process related to the observed phenomenon, project or operational process. During this activity, we examine the probability of risks occurring, their impact, and the measures required to prevent the risk or reduce its effect. Risk analysis methodologies can be used for process design, data integrity assessments, cross-contamination studies and many other areas.

Cleaning validation is a professional task: selecting the component(s) to be tested, defining sampling locations, developing sampling techniques, optimizing the measurement method, eliminating possible evaluation errors and determining validation limits all require experience.

Demonstrating the specificity, accuracy, repeatability, linearity, trueness, intermediate precision, detection limit, quantitation limit and robustness of analytical methods is a major challenge for analytical professionals. Statistical support for evaluating the results is especially important.

Every year, typically in early spring, our Wil-zone Academy training series has been held with great success for many years. In addition to our GMP Auditor and data integrity and computerized system validation (GxP IT) courses, we also plan to announce risk analysis trainings.

Information about current trainings is available under Events, or through Facebook and newsletter announcements.