HPLC Column Management Software
Constraints in Manual HPLC Column Booking Management
In pharmaceutical, life sciences, contract development and manufacturing organization (CDMO), chemical, contract research organization (CRO), biotech labs, HPLC (High-Performance Liquid Chromatography) columns are commonly used. Columns are a high-cost consumable component in the quality control laboratory. Regardless of cost, it is an essential element for QC sample analysis. Quality Control analysts do not know which solvents are in the buffers in the columns they’re inspecting, or which samples have passed through the system because of the existing manual booking and monitoring of column usages. This information is critical to avoid contamination.
- The vast majority of pharmaceutical companies track their Column Usage in handwritten logbooks. In manual column management, getting a thorough summary report on the column’s use and cumulative injections is a big problem.
- There is no record of column mapping, and the same column is occasionally mapped twice with two separate products. This causes lab analysts to get confused
- Because columns are expensive, tracking their utilization is critical for cost optimization in analytical labs. There are occasions when a column gets removed without ever being used since there is no good track of the columns, and analysts may eventually utilize a column that is too old. With the manual column usage logbooks, it is quite difficult to keep track of the columns correctly.
- Even more costly is the amount of time lost during sample runs due to random column failures and needless column re-equilibration.
The above challenges can be well explained by this Scenario.
“Going to the Column Drawer and reaching for a column I had no clue about after returning from a long weekend to start analyzing”
- What solvents are in the column now?
- How many buffers are there?
- What samples were run?
- Is the sample contaminated?
Before running the test, the analyst should empty the column and then re-equilibrate it to solve this issue.
This consumes a significant amount of the Analyst’s valuable time while managing HPLC columns.
Keeping track of HPLC columns and monitoring them for solvent identification is a time-consuming task. Organizations in the healthcare and life sciences industries find it difficult.
The packaging material and dimensions of their columns must be known by researchers and quality control analysts so that they may prevent cross-contamination and avoid any carryover by prepping the columns before an analytical technique is carried out and avoid any contamination.
Using the AmpleLogic HPLC Column Management Software, an organization’s laboratory can keep track and manage the use of all HPLC and GC columns and their associated operations
There are three initial screens in AmpleLogic Analytical HPLC Column Management Software:
- Product Details
- Column Master
- Column Usage
Features of AmpleLogic HPLC Column Management and Usage Tracking Software
- Each Chromatography Column is assigned a unique ID (bar code). in the inventory. Column ID, type of column, column length, part number of column, column make, serial number, stationary phase, length, diameter, particle size, and allowed number of Injections are typical details stored in a column array.
- It creates an Inventory of all HPLC Column Management
- The barcode feature assists the user in reducing human errors; users may view the information of the column using a barcode scanner.
Column to Product Mapping
- Columns are associated with a certain product code. The Quality Control lab analyst might utilize particular columns when analyzing a product sample. AmpleLogic digital column management software allows organizations to configure the system following their Quality Control Lab SOPs.
HPLC Column Booking
- The Quality Control analyst/Lab Technician can reserve a column for a certain product, date, and time using AmpleLogic’s distinctive Column Management Software
- The dynamic software will recognize individual column bookings for the product and never permit or show expired columns for reservation, therefore reducing non-conformance
- AmpleLogic’s Intelligent Column Management Software automates data entry into its relevant records, offers column care details, and information on storage conditions and validation checks. Additionally, it notifies users of the position and packing material for each column, as well as the performance and limits associated with their use. This enables the user to make the best possible use of Columns.
- Because the entire process is automated and a rigorous vetting mechanism is in place, it prevents duplicate Column reservations at the same time.
- When a column is in use, it cannot be utilized or launched for booking, and the system will display an error if a user attempts to book the same column.
Column Usage Logs
- Users can more easily manage and monitor each HPLC column’s performance, as well as data about cumulative injections. The program also keeps track of the column’s status and history.
- The column usage log allows for regulated data access depending on the user’s role
- The program assigns barcodes to the columns to generate column usage time automatically, which aids in extending the column’s life.
- Using the AmpleLogic HPLC Column Tracking software, the washing cycles of the columns will automatically create notifications and alarms at the set intervals, as needed.
- Allows users to verify the status of a column to see whether it is allotted or not. Users can also see which columns are inactive and which ones are in use. This enables analysts to choose the appropriate column for analysis.
- A retired column will appear on the system with the status ‘retired,’ and it will no longer be open for booking.
- AmpleLogic Electronic HPLC Software keeps track of the solvents and buffers used in prior analyses.
- AmpleLogic Column Usage Management Software creates dashboards and graphs that illustrate column performance over time.
- Users may produce and print Inventory reports, Column Usage reports, and Audit Trails for reference on column history using HPLC Column Software.
- Graphical reports, such as departmental columns and status columns, are easily obtainable.
- AmpleLogic HPLC Column Management Solution is built on a LCNC PLATFORM to reduce the cost of verification and, if necessary, dynamic modification.
It conforms with the requirements of 21 CFR Part 11, the US FDA, EU Annex 11, and other standards. AmpleLogic’s HPLC Column Management Software assists in the management of the Columns Manager following Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP).
Advantages of using the AmpleLogic HPLC Column Management Software
Column usage tracking
- It records the history of HPLC column usage across the full column life cycle, from column registration to column retirement.
- Notifications, reminders, and escalation alarms during washing cycles help extend the column’s life.
- To verify column usage history and product location details, HPLC Column Usage Tracking Software captures all relevant information. As a result, column management is more visible and secure, and there is less risk of noncompliance.
- It simplifies the booking and administration of HPLC columns
- Prevents duplicate column reservations from occurring at the same time
- The AmpleLogic Electronic HPLC Column Tracking program allows the user to pinpoint the exact location of the column. It also sends out automatic reminders and cautions about the column’s usage
- The system creates a Column ID and a Bar Code automatically
- Stock and inventory control is simplified with the system’s easy reporting and summarizing functions
- It generates dashboards and graphs illustrating the performance of columns over time
- By automating the whole process of selecting, preparing, and booking the column, High-Performance Liquid Chromatography Usage Management Software saves an analyst valuable time
Track of cumulative injections
- The HPLC Column Organizer Management Software has a function for documenting the number of injections for each column use; total injections are computed automatically by the software and are constantly monitored
- AmpleLogic Column Management Software is compliant with 21 CFR Part 11, EU Annex 11, WHO, cGMP, MHRA, and GLP regulations. It generates electronic signatures and audit trails
- AmpleLogic Column usage tracking software removes data manipulation that is characteristic of the paper-based system by automating and digitizing the whole process
Flexibility of design
- The application can be designed according to the custom needs of the organization since the AmpleLogic HPLC Column Management software is based on a GMP compliant low code platform. This also helps with adaptability and compliance with changing internal and external regulatory requirements.
TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH electronic record standards will also be met by AmpleLogic HPLC Column Booking Software.
Other industries that can take advantage of HPLC Column Tracking Software
- Medical Devices
- Contract Development and Manufacturing Organization (CDMO)
- Chemical Industry
- Contract Manufacturing
- General Manufacturing
- Contract Research Organization (CRO)
- Food & Beverages
Please get in touch with us if you have any questions about how AmpleLogic HPLC Column Management Software may help your company.