HPLC Column Management Software
Challenges in Manual HPLC Column Booking Management
High Performance Liquid Chromatography (HPLC Column) is widely used in Pharmaceutical, Life Sciences, Chemical and Biotech Laboratories. Columns are expensive consumable items in the QC Lab. Regardless of price it’s one of the most critical components required for analyzing the QC samples. Due to current manual booking and tracking of column usages, a Quality Control analyst is not aware of which solvents are in column the buffers in those columns and which samples went through the system. To avoid contamination this information is crucial.
- Most of the Pharmaceutical Companies use manual logbooks to identify and record Column Usage. One of the major challenges in manual column management is to get a detailed summary report on the usage of the column, and the number of cumulative injections.
- There is no track of column mapping and sometimes, the same column is mapped twice with two different products. This creates a confusion for lab analysts.
- Columns being costly, their usage tracking is essential to optimize cost in Analytical labs. There are instances when a column is retired without even using it as there is no proper track of the columns and sometimes analysts end up using a column which is too old. It is very difficult to track the columns accurately with the manual column usage logbooks.
- An even greater expense is the amount of time lost in carrying out sample runs because of random column failures and unnecessary re-equilibration of the columns.
The above challenges can be well explained by this Scenario.
“Returning from a long weekend to start analyzing going to the Column Drawer, reaching for a column having no idea about”
- What solvents are currently in the column?
- What buffers are there in the column?
- What samples went through the system?
- If the sample is contaminated?
To address this problem the analyst should flush the column and then equilibrate the column again, before the test.
This takes a lot of valuable time of the Analyst Managing HPLC columns
- Managing the inventory of columns and monitoring them to identify the solvents in an HPLC column can be a time-consuming process. Many healthcare and life sciences organizations find it to be extremely challenging.
Analysts within the research and quality control departments must be aware of the packaging material and dimensions of their columns so they can prevent cross contamination and avoid any carry over by preparing the columns before an analytical procedure is carried out.
AmpleLogic HPLC Column Management Software helps for tracking and managing usage of all HPLC and GC columns and their activities within an organization’s laboratory environment.
AmpleLogic Analytical HPLC Column Management Software has three initial screens
- Product Details
- Column Master
- Column Usage
Features of AmpleLogic HPLC Column Management and Usage Tracking Software
- Each Chromatography Column is listed in the inventory with a Unique ID (Bar Code). The typical details captured are Column ID, Type of column, Column length, Part number of column, make of the column, Serial number, Stationary Phase, Length, Diameter, Particle size, Allowed number of Injections.
- It creates an Inventory of all HPLC Column Management
- Barcode Feature helps the user in avoiding manual mistakes, users can use a bar code scanner to read the details of the column.
Column to Product Mapping
- Columns are mapped with specific Product code. While testing a product sample the Quality Control lab analyst can use specific columns. AmpleLogic digital column management software offers organizations the flexibility of configuring the system according to their Quality Control Lab SOP..
HPLC Column Booking
- AmpleLogic unique Column Management Software enables the Quality Control analyst/Lab Technician to book a column for specific product, date, and time
- The dynamic software will identify individual column booking for the product and never allow or display expired columns for booking therefore eliminating non-conformance.
- AmpleLogic’s Intelligent Column Management Software automates the entry of data in its respective records, provides details of column care and information related to storage conditions and validation tests. It also informs users of the location and packing material for each column along with performance and restrictions related to the usage of the columns. This helps the user in optimum usage of Columns.
- As the entire process is automated and there is a definite validation system, it eliminates duplicate Column bookings at the same time.
- When a column is in use, the same column cannot be used or initiated for booking, because the system will show an error if a user tries to book the same column.
Column Usage Logs
- It is easier for users to track and monitor each HPLC column performance along with details regarding cumulative injections. The software also tracks the status of the column along with its history.
- Column usage log provides controlled access for data, based on user roles.
- Columns are bar-coded with the software for auto-generation of column usage time which helps in optimizing the column life.
- AmpleLogic HPLC Column Tracking software program is designed to auto-generate notifications and alerts for washing cycles of the columns according to the assigned intervals.
- Enables users to check the status of the column to find out if a column is allotted or not allotted. Users can also check the columns which are idle and those that are in use. This helps analysts select the right column for analysis.
- A retired column will be displayed on the system under the status of ‘retired’ and the column will no longer be available for booking.
- AmpleLogic Electronic HPLC Software also keeps a track of the solvents and buffers which were in a column during previous analysis.
- AmpleLogic Column Usage Management Software generate dashboards, and graphs on column performance over the time
- HPLC Column Software allows users to generate and print Inventory report, Column Usage report and Audit Trail for reference on column history.
- Graphical reports like Department wise columns, status wise columns are readily available.
- AmpleLogic HPLC Column Management Solution is developed on LOW CODE PLATFORM in order to minimize the cost of validation and dynamic change if required.
It complies with 21 CFR Part 11 requirements, US FDA and EU Annex 11 and other standards. AmpleLogic’s HPLC Column Management Software helps in managing the Columns Manager as per the Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP)
Advantages of using the AmpleLogic HPLC Column Management Software
Column usage tracking
- Tracks the history of HPLC Column Usage for the entire Column Life cycle from column registration till retiring the column.
- Notification, reminders and escalation alerts on washing cycles to prolong the life of the column.
- HPLC Column Usage Tracking Software records all necessary information required for verification of history of the column usage along with location details of the products. This enhances visibility and security in column management and most importantly, avoids non-compliance.
- Streamlining the process of HPLC Column booking and management
- Avoids Duplicate Column bookings at the same time.
- AmpleLogic Electronic HPLC Column Tracking software allows user to find exactly where the column is located. It also automated reminders and warnings related to the column’s usage.
- System auto-generates a Column ID and Bar Code
- The system offers ease of reporting and summarizing, for stock and inventory control.
- It generate dashboards, and graphs on column performance over the time
- High Performance Liquid Chromatography Usage Management Software reduces the time spent by an analyst for selection, preparation and booking of the column by automating the entire process.
Track of cumulative injections
- The HPLC Column Organizer Management Software has a feature to record the number of injections for each use of column, cumulative injections are auto calculated by the software and are always tracked.
- AmpleLogic Column Management Software is 21 CFR Part 11, EU Annex 11, WHO, cGMP, MHRA, and GLP compliant. It generates e-signature and audit trails.
- As the entire process is automated and digital, AmpleLogic Column usage tracking software eliminates the manipulation of data which occurs in paper-based system.
Flexibility of design
- As AmpleLogic HPLC Column Management software is built on GMP compliant low code platform., We have the flexibility to design the application according to requirements of the company., This also increases compliance with changing policies from internal and external regulatory authorities.
AmpleLogic HPLC Column Booking Software will also comply 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 take advantage of HPLC Column Tracking Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages
If you would like to discuss how your business can benefit from AmpleLogic HPLC Column Management Software, please contact us.