Rescop’s Turnkey Projects division focuses on (corporate) high impact projects that require the integration of project management, engineering, commissioning, qualification and validation skills. Projects which are key for the customer to bring them to the next level of compliance and maturity.
Rescop gives support in design of facilities, utilities, equipment, IT infra.
Project Management, Software deployment, define Commissioning & Qualification plans, execute C & Q and validation are part of a Turnkey project. This is for Startups or existing companies, which work in the GxP regulated industries like Medical Device companies, Pharmaceuticals, Distribution centers, Hospitals, Research laboratories, construction, Food
Pharma 4.0, also called the smart factory, is a framework for adapting digital strategies to the unique context of pharmaceutical manufacturing.
This means more connectivity, productivity, simplified compliance and collecting digital production information to respond to problems as they emerge.Digitization, an important component of Pharma 4.0, will connect everything, creating new levels of transparency and speed for a digitalized manufacturing process. This will enable a faster process for decision-making and provides in-line and in-time control over business, operations, quality and compliance.Rescop has the unique combination of compliance software, consulting services and training services for GxP compliance to adapt digital strategies to the unique context of pharmaceutical manufacturing.
Support corporate implementation of new and upgrades for IT solutions e.g. SAP S4/HANA, concepts of serialization, by performing project management and validation. Modifications to existing facilities, utilities, equipment or products.
Support on Life Cycle Management processes. Rescop’s strength is paperless validation with our own software application.
Assessments of quality systems, process flows, product files and data integrity.
Rescop has experience with corporate quality and compliance programs; elements like Project management and governance, Assessment on Regulation and Standards, Prioritization based on criticality, defining remediations and validate the results.
Rescop has a standard data integrity toolbox available, developed based on 21 CFR Part 11, Eudralex Annex 11, the GAMP Guide and Rescop’s experiences in practice.
Possibility of deployment of onsite project team that has experience with data integrity projects and FDA / EU inspections is key for knowledge sharing and teamwork!
New facility +/- 200 laboratories BSL class 2, High containment Class 3 and upgradeable to class 4 laboratory.
New facility for API with Grow/dry rooms, Utilities, Laboratory (flowers and THCA) and equipment, Labelling and packing
New GMP storage facility of approx. 30.000 M2 with Temperature control rooms (cooling and freezing areas) and HVAC utilities
Existing facility with 20 Clean rooms class B and 9 Clean rooms class C&D, New HVAC Installation, New Control system for temperature, relative humidity and pressure and a new full continuous monitoring system for particle counting measurement
Rescop can help you regarding turnkey project servicesCONTACT US