SoftGroup® CoA

Introduction

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.

Benefits

  • Faster generating of CoAs;
  • Increased quality control;
  • Centralized management, tracking and reporting of CoAs;
  • Automated generating and printing of CoAs using templates;
  • Increased security achieved by limited user access to the system based on user roles, authority level and groups.

Logical structure

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:

  • One installation of SoftGroup® CoA and SoftGroup® Equalizer applications on a test server (test environment);
  • One installation of SoftGroup® CoA application on a production server (production environment);
  • One installation of SoftGroup® CoA database on a data server (test and production databases);
  • LAN availability.

Roles and access rights

Role:

Super user

LAB

QA1

QA2

QA3

ADMIN

Access rights:

Creates nomenclatures and generates reports

Enters batch data and generates CoAs

Approves CoAs at Level 1

Approves CoAs at Level 2

Approves CoAs at Level 3

Full rights

System modules

SoftGroup® CoA consists of the following system modules:

Nomenclature module

The Nomenclature module allows the user to create, edit or delete the following nomenclatures:

Destination
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.
Method of Analysis
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.
Companies
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.
Products
The user adds new products in this section, specifying the product name, print name and description.
Parameters
The user defines all product parameters in the parameters nomenclature.
Templates
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.

Certificates module

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:

  • Management of CoAs (create, edit, delete, print CoA);
  • Approval levels;
  • Audit trail of CoA.

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:

Header:

  • Name of laboratory;
  • Number of analytical certificate;
  • Date of issue;
  • Product;
  • Batch number;
  • Quantity;
  • Direction;
  • Number of container;
  • Date of retest for raw material.

Body:

  • Number of test;
  • Name of test;
  • Units;
  • Limits;
  • Results.

Footer:

  • Signature of the person in the laboratory who has checked the results and date;
  • Signature of the Laboratory Manager and date;
  • Signature of the Qualified Person (QP) and date.

Report module

The Report module is used to analyze all CoAs data for a given product and period of time.

This module includes:

  • Parameter values of a product, chosen by the user, for a given period of time;
  • Graphical visualization of parameter values;
  • Values for normal deviation, CPL, CPK and CPU.

Nomenclature data transfer application

This application is used for transferring nomenclature data from test to production environment. The user can select which nomenclatures to be transferred.