Quality Management Software GxP

Electronic Lab Notebook System (RC-ELN)
The Electronic Lab Notebook System replaces the traditional laboratory notebooks to reduce time and paper and ensures that all data is still managed in a secured way. The Rescop Electronic Lab Notebook System stores, manages and publishes records of research projects in accordance with GxP or non-GxP regulations.
Laboratory Information Management System (RC-LIMS)
As a laboratory you manage data, monitor progresses, set KPIs for laboratory management and at the same time you would like to have interfaces with other software applications for your laboratory processing phases. The Rescop Laboratory Information Management System controls, supports and manages the entire sample life cycle, in accordance with GxP regulations.
Deviation and CAPA System (RC-Deviation)
Regulated industries face the challenge of maintaining a consistent level of quality regarding the CAPA processes within an organization. Therefore, it is of vital importance to perform systematic investigations with the support of Deviation and CAPA Software to approach non-conformances and you will be guided through a configurable workflow to minimize risks.
Document Management System (RC-DMS)
The Rescop Document Management System stores, manages and processes quality documentation in an efficient, effective and safe manner. Users are able to publish SOPs, validation documentation, batch records etc., in accordance with GxP regulations.
Quality Management Suite (RC-QMS)
Our quality management suite RC-QMS forms a comprehensive solution for quality and compliance management within GxP regulated industries. It contains products for all key quality management processes, and these products have been designed in such a way that they integrate seamlessly with each other, to enable an efficient and fully paperless quality management system.

Comprehensive solutions for quality and compliance management within GxP regulated industries

A fully web based solution, which runs on the common browsers and is cross-platform compatible to allow for use on any device type, including pc’s, laptops, tablets and smartphones.
Furthermore, we offer IT services and solutions to establish and maintain a GxP-compliant and reliable IT infrastructure and application landscape for continuous business operations.
Our portfolio provides a full solution for ensuring permanent inspection readiness in an efficient way. Moreover, our software products enable paperless validation and compliance.

Industries

We believe that a single all-in-one platform should provide all aspects that a GxP Compliant company needs. With our product you can be compliant without any paper.

 

Our Customers

30 January 2018

SECOND ROUND-TABLE AGILE VALIDATION - PRACTICAL CASES

Description: At Rescop we recognize Agile (Scrum) is used more and more in development and configuration of computerized systems. Like in traditional validation, Scrum teams are focused on delivering quality and meeting customer requirements, although, using the Agile terminology and deliverables.
For more information visit www.rescop.com/second-.....tion/

Kasteel Cammingha, Camminghalaan 34, 3981 GH Bunnik.

15 March 2018

Agile Validation Experience (2 days) - Breda, The Netherlands

Description: www.rescop.com/agile-v.....8-nl/
Golden Tulip Keyser Breda, Keizerstraat 5, 4811HL Breda, The Netherlands

GAMP 5 Experience (2 days) - Breda, The Netherlands

Description: www.rescop.com/gamp5-t.....8-nl/
Golden Tulip Keyser Breda, Keizerstraat 5, 4811HL Breda, The Netherlands

10 April 2018

Loes Kalkman - Rescop Principal Consultant is speaking at the GMP & GDP in three days

Description: Loes Kalkman - Determination of risks within Computerized System Validation.
The management of risks is an essential part of Computerized System Validation. This seems to be easy, but it turns out that a lot of risks are not considered which can jeopardize patient safety, product quality and quality of data. The following topics will be discussed:
· Organizational structure (QMS);
· Validation procedures (initial risk assessment with different types (technical/compliance);
· Methodology for applying risk assessment (FRA, FMEA);
· Project Management;
· 3 P's (risks): Process risks, Product risks, Project risks;
· Experience and validation knowledge of employees involved in validation activities.
For more information on the ‘GMP & GDP Driedaagse 2018’ visit www.gmp-driedaagse.nl/. Please note that the language used during this event is Dutch.
Golden Tulip hotel het Ampt van Nijkerk, Berencamperweg 4, 3861 MC Nijkerk

10 April 2018

Jos Nieuweboer - Rescop Principal Consultant is speaking at the GMP & GDP in three days

Description: Jos Nieuweboer - Criticality Analysis as QRM-tool.
A criticality analysis has the purpose to understand and control all product risks and can be summarized as the critical management of a drug product and its production process.
A critical analysis is:
· The combined knowledge of the ingredients, production process and of the final drug product;
· A risk based approach to determine which attributes are critical to the quality of the drug product and to the safety of the patient;
· The outcome of the analysis summarized in a single document (the criticality analysis report).
During the lecture the steps for the execution of a criticality analysis – and the attention points – will be explained.
For more information on the ‘GMP & GDP Driedaagse 2018’ visit www.gmp-driedaagse.nl/. Please note that the language used during this event is Dutch.
Golden Tulip hotel het Ampt van Nijkerk, Berencamperweg 4, 3861 MC Nijkerk

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