Quality Control and Assurance are the corner-stones of drug manufacturing industry. Maintenance of quality of material that goes into production of a commercial drug or active pharmaceutical ingredient (API) is critical to the manufacturing process. To maintain high standards, quality is checked at each and every phase of production, right from raw material receipt, through intermediate phases of the manufacturing process, to the final product. This process requires extensive use of tests and protocols that determine QC of the material, prompt communication between various departments to minimize latency in the process and efficient management of resources to maximize output.
One of the major challenges in keeping up with the critical requirements identified and stringent regulations set by federal institutions for QA/QC processes in the industry, is maintenance and management of data generated during the process. Keeping manual track of the entire exhaustive process of quality testing on raw material lots, intermediate batches, in-process samples, final product, stability check of the final product, is daunting and highly error-prone.
Ocimum’s PharmaTracker is a Commercially-off-the-shelf (COTS) solution, designed to address these critical and growing needs, with built-in industry specific functionality and highly flexible and configurable options.
Why Ocimum’s PharmaTracker™
- Streamline Quality Control process.
- Move from paper-based system by automating all the laboratory processes.
- Minimize transcription errors and achieve real time tracking of process status.
- Enhance process efficiency and decision making ability.
- Seamless and automatic communication between material stores, QA&QC labs, production and packaging departments.
- Ensure process control, security and tracking to support FDA’s 21 CFR Part 11, GLP and GMP compliance.
QA&QC SPECIFIC MODULES
- Masters Management – Define material masters and inventory masters, test masters, specification and their approval process, save QC test methods.
- Management of Material Batches – Register new batches of raw materials, intermediate and finished products. Capture batch quantity, number of containers, vendor information, COA, manufactured date, specify retest/expiry date, enter damage & spillage information, specify storage locations such as open quarantine area, storage tankers, etc.
- QC Process Tracking - Schedule and capture sampling process, capture sampled count and quantity, perform identification tests on samples, create composite sample, perform QC tests – physical, chemical and instrument based – including identification on pooled sample, define and build formulae for automatic test result calculations, approve quality of batch, automatic updates of process status based on actions performed.
- OOS Management - Highlight Out-of-Specifications captured in QC tests and alert relevant resources, manage Corrective And Preventive Actions (CAPA).
- Resource Management and Task Scheduling – Assign sample collection and test execution tasks to qualified personnel, maintain and view task load of a selected resource to before assignment of new tasks. Define review, approval and task assignment privileges, add users and create user groups.
- Reports and Trends – Generate Sampling report, Analytical Test Report (ATR), Test Summary Report, etc. Generate trend reports and graphs for test results across tests, batches and time periods.
- Web based, browser-independent solution.
- Database Agnostic.
- Works on tablets and PCs.
- APIs for easy, faster and secured data exchange with third party software and instruments.
- Audit trails, User logs, GLP and GXP, 21 CFR Part 11
- Test Design - Create new test templates, specify test inputs and observation parameters, associate approved test templates to relevant material masters, save specifications for the test on the material
- Instrument Management - Maintain and register new instruments, manage their calibration, maintenance and qualification information, specify vendors and service contract information, define instrument interfacing settings and track usage.
- Inventory Management - Maintain and register new inventory, manage multiple containers of inventory, initial and current quantities, track inventory usage and inventory validity. Add documents such as MSDS and associate vendor information.
- Task List - Assign, view and execute tasks. View task load on each user before assigning tasks. View task schedules and overdue tasks.
- Review & Approval - Submission of executed tasks and test results for review, view list of pending reviews and approval requests, review test results, approve and release batches, or return raw material batch to vendor.
- Resource Management - Personnel Management, Role Management, Vendor management, Customer Management.
- System Settings Management – Specify Password settings, Email settings, Barcode Design settings, Electronic Signature settings, etc.
- Utilities – Audit Trails, Dashboard, Controlled Vocabulary
Available as “On Premise” or “SaaS” model. Whatever be the model, “you will hold complete rights on your data”.