Validation of computerised systems (PQ)

Today's GCP and GVP environments are highly regulated and systems and processes need to be validated against high standards. The validation process needs to start with careful planning. 

All actions during the validation process have to be documented in detail. Also the completion requires various assessments and documentation. Validation may include testing your gateway with the European Medicines Agency (EMA). After Go-Live, the validated state of the system needs to be maintained.

When being compliant with these regulations and operating a fully GxP validated and controlled system, a possible GCP or GPVP inspection carried out by national Competent Authorities or the EMA will not be a challenge.

The Lindeq team has many years of experience with validation of safety databases and together with our partner Dr. Teri Stokes at GXP International we plan your validation process and assist your validation team. We also streamline your system SOPs ensuring ongoing change control measures in order to maintain your GxP validation status.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.

Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
Quality Management System
Web-based quality management system software including training and document management
Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
Full range of cosmetic product safety services for all different types of cosmetic products
Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)