Pharmacovigilance related IT

 

Lindeq provides also pharmacovigilance related IT support. From PQ validation of computerized systems and safety database software to data migrating and mapping and EMA gateway testing.

Together with our partner BaseCon, Lindeq offers also a complete and resource saving safety database software including drug safety services.

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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.



When adopting a new safety database the legacy data from the old system must be imported (migrated) to the new system. Before migration can occur, the data fields in the new database need to be mapped to the data fields in the legacy database. This ensures that data comes into the right data field.

The methods to do so can vary, together we will figure out how to proceed in your individual case. If changes to the new safety database requires data cleaning (prepare old data in a way that it meets all criteria of the new system without losing any information) we include this task into the service, making sure that your new system is compliant with all standards and include all previous collected data.

Besides data migration and mapping, changing to another safety database also implies the need for a validation of the new system in order to be compliant with the standards defined by Competent Authorities and EMA. Lindeq can provide assistance with PQ validation.

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



Together with BaseCon, a provider of IT pharma solutions, Lindeq offers a complete and resource saving safety database solution: Safety Base Interchange (SBI) including set up, validation and maintenance.

 

Lindeq also provides the option to include the complete safety data management within this solution, consisting of:

BaseCon provides the user-friendly web-based database developed to manage your safety data during the entire lifecycle of your medicinal products. The SBI is adjustable to your individual needs. This can include an optional electronic reporting module (gateway). The SBI allows you to have your complete safety data available at one point with access from anywhere, at any time.

Lindeq sets up the database at the user's site and performs end user validation (PQ testing), populates the company drug list and tests the gateway with EMA, Regulatory Authorities and other partners you might collaborate with. All procedures are performed in compliance with the current regulations.

BaseCon and Lindeq have collaborated for many years, ensuring high service and an efficient and fast implementation of your SBI safety database.

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

 



Prior to using a new safety database, the correct electronic transmission of ICSRs to the EMA has to be guaranteed.

The safety database owner must test the correctness of the XML files before transmission in order to be compliant with specifications like e.g. data dictionary compliance or field lengths. This test phase is done in co-operation with the EMA who receive and evaluate the information received.

Lindeq provides EMA gateway testing including preparation of the Implementation Plan, operational phase and provide you the final acknowledgement of receipt, issued by EMA. 

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






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