SoftGroup® CoA is a laboratory data management system for management, tracking and reporting of Certificates of Analysis (CoAs) in the analytical laboratories of pharmaceutical producing companies.
SoftGroup® CoA automates the generating and printing of CoAs. The main purpose of the system is to switch from paper-based to electronic management of CoAs.
The system stores the final results from tests performed on the samples. The stored data can be used for analysis of all product parameters for a given period of time. The data can be exported in several formats to meet customer specific needs.
The system also provides user access policy, history of laboratory activities (audit trail) and different approval levels.
SoftGroup® CoA is a client-server product that is installed on test and production environments.
The test environment is used for creation of all nomenclatures (Nomenclature module) and their transfer to production environment.
The production environment is used for generating, printing and reporting of CoAs.
The users can access these environments via Microsoft Remote Desktop Services (RDS).
Minimum requirements for normal functioning of the system are:
SoftGroup® CoA consists of the following system modules:
The Nomenclature module allows the user to create, edit or delete the following nomenclatures:
Each batch is produced for a specified order, country and market. The method of analysis can be different for different countries. All countries will be defined as destinations.
The user adds new products in this section, specifying the product name, print name and description.
Method of Analysis is a sequence of activities defined like rules for tests of every parameter. SoftGroup® CoA stores only the method names. Methods are classified nomenclature data and will be defined during the system implementation.
The user defines all product parameters in the parameters nomenclature.
Companies are the customers. The user can fill in a company name and an address (optionally). The system allows different parameters or/and methods or/and acceptance requirements to be defined for one country, but for different customers.
The templates are pre-defined forms, based on which the CoAs are generated. The user creates templates for all products with parameters for analysis and acceptable limits. The templates are dependent on a product and destination. The user can add a destination and company in the template. Templates are classified as nomenclature data and will be defined during the system implementation.
This module is used for generating and printing of CoAs for finished products, raw materials and packaging materials.
The Certificates module has the following functionalities:
The finished products are divided by batches according to customers’ orders, market and destination. The batch is created before the manufacturing process starts. In the laboratory, the batch is logged in before the sampling process starts. Every batch has a unique identification number, date, parameters, acceptable values for the parameters, etc., which are defined by the user in the laboratory.
The batch is created by the user, using a template. Templates are pre-defined in the Nomenclature module.
The CoA print layouts are customized during the system implementation. A CoA may contain the following example data:
The Report module is used to analyze all CoAs data for a given product and period of time.
This module includes:
This application is used for transferring nomenclature data from test to production environment. The user can select which nomenclatures to be transferred.
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