About Qualitate
In 2018 Serial Testers introduced its new commercial name: Qualitate, to align more with the reality of its solutions and services.
In the last 6 years we have become a technology partner for important companies in the pharmaceutical sector and their quality assurance programs for in-house computer systems.
Qualitate – Our name reflects our vision of quality in all its aspects: in the solutions we implement, in the way we provide our services and always with the focus on quality assurance at a cost optimized for our clients.
Our goal is to be the technological partner of reference for the life sciences sector. We focus on innovation, risk mitigation and optimization of project duration while ensuring regulatory compliance.
We accelerate the delivery of quality systems developing and implementing innovative and robust services and solutions for our customers.
Our solutions are deployed applying current good practices. With a multifaceted and international team of seasoned consultants your projects are in good hands.
Partners
Integrate applications
Electronic signature
Complete management
Report generation
Immediate visibility
Orderly validation
A single application to integrate IT systems.
Use the electronic signature in all review and approval processes,
relegating the file and paper support.
Define the user requirements, functional specifications, risks...
with total traceability, auditability and data integrity.
"One click" to generate risk assessment´s reports,
design reviews and traceability matrices.
Instantly know the status of the entities and the coverage
of the test with the defined requirements.
Ensure that protocol approval and test execution
meet the specified criteria to validate.
More characteristics
Definition of requirements, functional designs, risks, acceptance criteria, tests, validation protocols, deviations and reports with a guarantee of auditability and traceability between each of them.
Incorporating electronic signatures for all revisions and approvals that are always compatible with 21 CFR Part 11 and for each of the records managed in the system.
Generation of reports of risk assessments, design reviews and traceability matrices, all done with a single “click”.
The approval of the protocol and execution of the tests meet the specified criteria for validation.
Instant visibility of the test coverage for the defined system acceptance criteria.
Company-wide implementation of a single application to manage the validated state all your computerized systems.
Request a no commitment demonstration
Clients
