ViMS - Qualitate

ViMS is the application of reference for the life sciences sector, because it guarantees 100% compliance with the regulatory environment in its validation processes!

Qualitate is a consultancy company specializing in the life sciences sector that has developed ViMS – Validation information Management System.

Using the life cycle management applications from our technology partners Micro Focus – Hewlett Packard Enterprise, and with the advice of specialized consultants in the life sciences sector, Qualitate guarantees that its validation processes are adapted to the legal framework, such as 21 CFR Part 11, EU-GMP Annex 11 and GAMP.

The entire life cycle according to GAMP5 in a single solution!

ViMS provides integrated management of requirements, risks, testing, validation protocols, deviations and reports, in addition to carrying out a risk analysis and mitigation management.

Consultants specialized in the life sciences sector and cutting-edge life cycle applications, Micro Focus ALM, are one of the pillars of ViMS that ensure data integrity and homogeneity of validation processes while avoiding duplication and ensuring that the requirements of the regulatory environment are met.

Validation systems 100% adapted to the regulations!

ViMS implements the processes of management and validation of computerized systems “out of the box” and according to GAMP5.

Dedicate effort in the simplification of your processes and recover your investment sooner

ViMS is a turnkey application built on Micro Focus ALM, fully adapted to the regulatory environment and is supported by technology partners that verify and certify its functionality, offering access to a Service Desk with guaranteed service agreements.

ViMS implements integrity checking to prevent and detect unauthorized alterations of any data.

ViMS achieves total traceability and visibility of changes, without incurring duplication.

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What is ViMS?

ViMS is an integrated solution for life cycle management and validation of computer systems.

We start by capturing and defining the User Requirements Specifications (URS) and continue up to the issue of the validation reports, including the critical results of the project such as risk analysis, design review, and IQ, OQ and PQ protocol definition. Everything being done in a traceable, effective and safe way.

Why ViMS?

ViMS has been developed to be compliant with the regulatory environment and is the reference application for the life sciences sector, it incorporates electronic signatures and in doing so decreasing the use of and need for hard-copy document based records, by streamlining the validation and registration processes, by providing total traceability and visibility of the changes, and guarantees the integrity of the data and the mitigation of risks.

Challenges of the Industry

We asked our clients about their most difficult challenges for project validation teams and their answers are …

It is increasingly difficult to manage and maintain the traceability of all software releases in the end-to-end process, from the user requirements through to the verification and validation of the system.

The management of deviations is difficult and time-consuming, especially when managing the traceability of defects to the affected requirements and the test cases.

Paper-based validation activities are difficult to perform and it is a challenge to keep the documentation updated; In addition, it is not easy to ensure that all projects consistently adhere to the defined criteria.

Document management, especially for the validation, is costly since this information is kept in documents that are often stored as a hard copy in multiple locations with the inherent risk of losing them.

What does ViMS offer?

ViMS represents an integrated solution for life cycle management and system validation, providing end-to-end support for the various phases of the software life cycle.

A sure way to comply with standards and allows records to be used as supporting evidence for the purposes of validation and provides traceability throughout the whole life cycle.

Auditability and Traceability

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.

No paper!

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.

Report generation

Generation of reports of risk assessments, design reviews and traceability matrices, all done with a single “click”.

Orderly validation

The approval of the protocol and execution of the tests meet the specified criteria for validation.

Instant visibility

Instant visibility of the test coverage for the defined system acceptance criteria.

Unique source of information

Company-wide implementation of a single application to manage the validated state all your computerized systems.

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