GMP Inventory Management
Analytical standards, reagents, chemicals, API’s or other materials can be followed up in a compliant manner. Usage records can also be held, and the system can provide you with updated stock information or usage log records. You can also set up critical parameters in the system, so that the system lets you know what materials are to be ordered, what materials are about to expire and so on.
Analytical Instrument and Column Management
Analytical instruments and columns can be followed up using this module, you can observe how well an instrument or column performs and make efficiency analyses. Lifetimes and critical dates such as calibration/validation dates can be followed up from this module as well.
Analytical/Production Method Management
In this module, you can define your analytical/production methods or use predefined ones to guide your users for method execution and data entry. Thus, you ensure that your operators work compliant with your procedures and prevent usage of draft or unapproved procedures. Pharmacopeial and generic methods are also provided in the system for your convenience.
Analytical Sample Tracking
This module lets you follow-up your samples, investigate batches and their analytical trends or create certificates of analyses. You can register your samples from production in this module and assign them analyses and procedures. This way, workflow in the lab is generated, your analytical specialists will know what to analyze, how to analyze and when to analyze.
Project and Resource Planning
In this module, you can define the work to be done under the project header and can assign resources such as workforce and money to projects and can compare estimated and real resource usage data. This allows you to monitor your project activities or resources and to take action if necessary.
Analytical Records Module
You can record your analyses in a compliant manner in this module. Operators are assisted with method execution and data validations are performed against method acceptance criteria. Entered data provides insight about lab performance, as well as the quality metrics and KPI’s reqired by the authorities.
Production Records Module
Just like the analytical records module, you can define your production procedures and recipes for the recording of your production processes. You can have the system check for the required materials and workforce for convenient and efficient production process management.
User Defined Inventory and Documentation
This module aims to let you manage your GMP or business critical documents and spreadsheets in a compliant manner, which cannot be managed by any other software module. If you have a pile of GMP/Business critical spreadsheets you do not know how to make compliant and validate, then this module is for you!
Analytical/Process Validations Management
If the user requires to validate a method then this module is definitely the one to use. It will guide the user through the validation process, in the light of current regulations, collect, evaluate and report necesssary data. This way, validating analytical or production methods will be less error-prone and much more quicker.
Stability Program Management
Within this module, you can prepare a stability program at the touch of a button for the selected sample or batch. The system will not only let you know when a stability analysis is due, but will also collect analysis results and provide you with trends and KPI’s, plot charts or tabulate results.
CTD Dossier Management
For your drug development activities, a CTD dossier management module will collect the results of all the hard work you performed and let you organize and modify your data. You can use predefined templates to cut down on manual formatting work.
Compliant Security Management
This module with let you to operate your software in a secure and compliant manner. Here, you can manage your users, their passwords, privileges, system audit trails and many more operations. You can also establish system compliance and security policy and preferences here.