QC Planning and Scheduling Software for Pharmaceutical & Biotechnology
Life Sciences companies include Pharmaceutical, Biotechnology and Biosimilars continue to operate in a highly competitive environment. The Quality Control (QC) laboratory in a pharmaceutical company plays a critical role in the testing of Raw Materials, Stability, In-process and FG Samples. QC Analysts from different sections analyse incoming samples of different kinds. These include Finished Goods (FG), in-process products, stability samples, and environmental samples. Analysts may also be required to analyse raw materials.
In organizations with diversified drug products, the number of samples to be tested per week will range from 150 – 400 Samples and each sample must go through a minimum of 6 tests. In such a scenario it is a challenge to prioritize the samples and assign equipment like HPLC/GC to the QC Analyst manually.
HOD’s of QC Labs are under steady pressure to improve the lab operations in order to meet the Sample TAT (Turn Around Time). The equipment used in the Pharmaceutical and Biotech product testing are highly sophisticated, extremely sensitive, and very expensive. Maximizing both staff (Laboratory technicians and managers) time and machine time is essential in the QC lab to address the problems of varying demands and to maximize resource efficiency.
Consequently, Planners/Managers are finding a way to move towards lean QC lab by improving their processes, improving effective utilization of resources, reducing lead times, and at the same time, increasing reliability by accelerating authorization processes for compliance. This affects both production and batch release.
A good Quality Control Planning describes how an organization will achieve its quality goals by specifying the quality assurance and control activities which are performed as part of daily lab operations.
Some of the challenges of manual planning and scheduling in QC Laboratories
- QC labs are required to register information about all samples received in the lab by making manual entries in books, paper records or excel sheets from LIMS
- Difficult to manage and maintain scheduler or planner for allocation of resources within multiple sections in a lab where there is a high volume of samples or tests to be planned and several schedules to perform the actions
- QC labs are required to analyse different types of samples like Finished Goods, Raw materials, in-process, stability samples as well as environmental samples. The analysis must be carried out on the basis of demand and priority. Organizations may find it difficult to manage and create proper scheduling based on the availability of Equipment Instruments and Analyst’s availability, etc.
- Rescheduling the day or weekly work plan in some scenarios like re-test, re-samples and OOS is challenging
- Allocation of resources like an instrument for analyses, and identifying the analyst who must perform such actions is a major challenge to track down
- Organizations incur high operating costs because of uneven workloads on the workforce and improper planning.
- Slipping of schedule like adding a resource can bring the schedule back to its actual or original timeline. Making other adjustments like additions or removal of certain test cycles, and resources that impacts the delivery timelines can also be difficult
- There is no proper planning for some of the samples that are to be tested based on demand, and priorities.
- A lot of time and resources are used by the lab technicians, analysts, planners and schedulers to manually plan the tasks. This increases the total number of work hours for a task increasing operational costs.
- Generating the reports of analyses from different instruments like HPLC and where analysts have to report the delays that are taking place during the process. i.e, delayed availability of the equipment or instruments for the analyst, or calibration issues, or waiting for analysts or technicians during the group of test samples.
- Managing Equipment and analysts during OOS is a concern for many organizations. There are several instances in companies where analysts may end up using non-calibrated instruments for analysis because they are unable to identify calibrated and non-calibrated instruments from a group or list of instruments.
- All forms of manual entries and processes followed in an organization is prone to errors and inaccuracies. This can decrease the overall lab efficiency
In order to avoid the complexity of scheduling, an ideal solution is required to minimize the time invested by the workforce in carrying out their tasks. It is also important to increase flexibility in processes allowing changes in schedules based on demand and optimizing the lab efficiency, performance in terms of test cycle times and on-time deliveries
AmpleLogic “QC Planning and Scheduling” Software
AmpleLogic QC Planning and Scheduling Software is a web-based solution designed on LOW CODE PLATFORM specifically for Quality Control and R&D Laboratories. It helps you to plan and schedule your resources, track the laboratory activities and generate user configurable reports for swift decision making. Features like resource scheduling, sample batching/ campaigning helps in moving towards lean QC lab practices.
AmpleLogic QC Planning and Scheduling Software Program is a solution for organizations that aim to improve lab efficiency by introducing automatic calculation of efficiency of every analyst by studying the completed samples or actual tests performed by them. This feature enables both analysts and management to track their individual performance and efficiency. It also provides with an overview of the reasons for delay, and for time consumption by the analyst. The software provides insight to identify whether the analyst requires additional training and list of challenging tests in the labs.
With the help of the program a lab technician or an instrument can be blocked to analyse or investigate. This reduces the number of deviations or non-conformance for the organization.
AmpleLogic Solution will allow you to connect from anywhere any time. Ensures data integrity, regulatory compliance, and traceability. AmpleLogic QC Planning & Scheduling Software complies with FDA 21 CFR Part 11, EU Annex 11
Features of Quality Control Planning & Sample Scheduling Software
- Create and set a paperless lab scheduling and shift-based planning taking into account resource availability and TAT (Turn Around Time).
- Provides accurate resource needs based on the organization’s unique requirements and accordingly creates or delivers a laboratory QC Plan with a single click.
- Scenarios related to analysis of Finished Goods and stability can be treated as urgent and a separate test schedule can be created in this case. It can be done for any analysis which must be completed within a day
- The calendar will display daily, weekly, monthly or annual schedules for analysts across the laboratories.
- AmpleLogic QC Planning solution has different color coding for which helps analysts identify the schedules according to criticality, delay or when they are overdue.
- The software automatically sends emails and notifications to your analysts communicating crucial information related to the scheduled activities or escalations
- Automatic Planning and Scheduling delivers daily, weekly or monthly schedule which allows you to track a QC analyst or an instrument’s availability. The System can automatically block the resources for the period of time that an OOS or a Root Cause (RC) analysis is underway in a laboratory by different analysts
- Organizations have a transparent and complete view of their lab performance and resource utilization according to the daily, weekly and monthly calendar along with easily customizable reports.
- Users can track reports of each employee or if the resource is assigned for optimal usage. Real-time data gives the overview of shortfall or excess of resource allocation. This helps users promptly address any problems related to resource allocation.
- The program helps users view every task assigned to the analyst for completion. It also shows the amount of time spent in performing a test and the estimated duration for carrying out a test.
- Using the software, test activities can be automatically scheduled by checking for analyst’s availability, qualifications, and experience level. The system also accounts for the due date of the test along with critical path tests, batch size and its priority.
- Supports regulatory compliance by providing organizations with a complete audit trail which includes electronic signatures, email alerts and field level security.
- Gives QC planners instant real-time visibility of each team availability against the current work, unavailability, etc.
- Based on product grouping and campaigning we can group different samples to minimize the overall test time.
- Allows you to create customized reports and charts. Users also have the option of importing or exporting data to excel spreadsheets in order to conduct detailed analysis.
- Auto generate reports on weekly/monthly basis. Users can monitor key performance indicators (KPI’s) based on samples, completion of time and employee performance
|Analyst task report||Instrument Occupancy|
|Occupancy of Analyst||Sample wise|
|Grouping wise||Schedule Test wise|
|Resource Utilization||Instrument Utilization|
|Column Occupancy||No. of usages on columns|
Benefits of QC Planning & Scheduling Solution
- Adherence to the Sample TAT (Turn Around Time)
- AmpleLogic QC planning application is simple user-friendly. It includes drag and drop feature, along with options to schedule and reschedule your daily lab activities and resources.
- Manage, view and edit schedules from anywhere at any time and give employees instant access from any web-based browser.
- Easily integrated with different types of data sources including ERP, legacy system and other existing systems to help you build a cohesive environment for QC planning.
- Configure the solution to your specific or unique requirements when it comes to creating, planning and scheduling the activities.
- Single dashboard provides you to see and take appropriate action against all your job activities.
- Helps organizations in managing and optimizing their resources. This supports higher productivity and increases efficiency.
- Eliminate the need for maintaining paper records to increase lab efficiency and minimize errors. And consolidate your data into a single repository, saving the time you lose in looking for information.
- Enhance communication and visibility for all departments and functions., It can reduce the emails, and phone calls between departments to learn about the status of samples.
AmpleLogic QC Planning and Scheduling Software will support the head of departments, managers, and supervisors in allocating the different tests required to release different samples to various analysts, based on critical, due date, work-load and other parameters
GMP Compliant QC Planning Software also complies with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.
Other industries that can benefit from our QC Lab Scheduling and Sample Tracking Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing