SampleManager Pharma

Laboratory digitization

Fast and compliant solution for quality control laboratory digitization

Problems Solved, Results Delivered

Laboratory digitalization

SampleManager Pharma

SampleManager Pharma is designed to provide a fast and compliant solution for quality control laboratory digitization. Typically the solution is ready for qualification within three months.

It achieves this with a preconfiguration, based on many years of experience, that captures laboratory data through notebook, instrument data capture or integration.

The preconfiguration has been operationally qualified which provides the customer with an opportunity to save time and cost in validating the solution.

Fast and Compliant

From Raw Materials to Product Release

SampleManager Pharma manages the testing protocol for Raw Materials, In Process and Finished Product / Product Release, with the option to integrate to ERP.

The Sampling Plan for a material drives the testing with automatic test assignment and results comparison against specification.

The Lot Review enables the full lot and its meta data to be reviewed, including instruments, inventory and stocks.

Certificate of Analysis can be generated to market/client specific format with configurable rules.

Process

Stability Studies

are managed using multiples variables, i.e. time points, packaging and temperature.

The study is subject to review and approval.

Samples are automatically created based on the study protocol.

Inventory required and used for the study is calculated by the module.

Environmental Monitoring module

enables the plant to be modelled using locations and sample points. Schedules of sampling are setup based on the risk analysis. The module pre-logs in samples for collection which can be done using a tablet and scanning.

Data Report

Data is available for extensive graphing and reporting, including by room, by grade, sample type, e.g. water, air or personnel.

LIMS

Once the core requirements are agreed for the LIMS can be ready for testing and validation after three months. This is based on the established practice of five to seven sprints.

 Data loading is facilitated with tools for uploading the data.

 As all of the functionality is out of the box then using a risk-based approach validation can be limited to Installation and Performance Qualifications. Templates are available for both.

Your Trusted Laboratory Informatics Partner

SampleManager Pharma

A rapid solution to address data integrity challenges in your laboratory. If you would like a free consultation without any commitment on your part please complete your details. We will provide you with a full solution scope.

LIMS implementation

Laboratory integration

Resource management

Consultancy

Contact Orbis Labsystem

We always want to hear from you at Orbis Labsystems. Contact us today to find the solutions for your Laboratory Informatics needs.