What is Vendor Validation in LIMS?

Vendor validation is the process of assessing, qualifying, and continuously monitoring suppliers to ensure they meet the lab’s operational and regulatory requirements. When integrated into a LIMS, this process becomes centralized, traceable, and far more efficient reducing the risks associated with non-compliant or unreliable vendors.

Why is Vendor Validation Important?

Vendor validation isn’t just a quality best practice—it’s often a regulatory requirement. Standards like GxP, ISO 17025, and 21 CFR Part 11demand that labs demonstrate full traceability and control over their supply chain.

Here’s why vendor validation is critical:

• Regulatory compliance: Ensures suppliers meet industry standards
• Risk reduction: Minimizes contamination, downtime, or testing errors
• Audit readiness: Provides complete documentation during inspections
• Cost control: Helps identify high-performing, cost-effective suppliers
• Operational efficiency: Reduces rework, wastage, and vendor-related delays.

How LIMS Supports Vendor Validation

A modern LIMS includes built-in vendor management modules or integrates with procurement systems to help laboratories:

• Maintain a validated vendor list:     With complete profiles, approval status, and contact info.
• Track documentation:     Certificates of Analysis (COA), ISO certifications, MSDS, and more.
• Set validation workflows:     Automate vendor approval, qualification, and revalidation steps.
• Monitor performance: Record and rate vendor issues, delays, or non-conformances.
• Enable alerts: Get reminders before certificate expiry or scheduled audits.
• Ensure audit trail: Maintain full history of vendor interactions, document changes, and decisions.

Key Benefits of LIMS-Based Vendor Validation

• Centralized Control: No more scattered spreadsheets or manual logs.
• Proactive Compliance: Alerts for missing or expired certifications.
• Improved Supplier Quality:     Performance tracking leads to better vendor decisions.
• Reduced Audit Stress:     Documentation is organized, up-to-date, and easily retrievable.
• Integrated Workflows: Seamless connection with inventory, procurement, and quality control.

Conclusion

Vendor validation is not just a compliance checkbox—it’s a strategic tool for maintaining lab quality, reducing risk, and improving operational performance. By managing this process through LIMS, laboratories can automate workflows, ensure data integrity, and stay prepared for audits at any time.

Across automotive supply chain, validating the physical behaviour and performance of automotive components is key to safety of customers and will also improve driving experience.

Measuring various parameters like compression, resistance, lamps, pedal se sensors, tension, strength etc. on individual components and sub assemblies in accordance to international standards is necessary before automobiles can be released to outlets for sale.

Why is it necessary?

Quality control is an important factor for Original Equipment Manufacturers (OEMs) of Automobiles require the best in quality components through the supply chain. High quality is needed to meet customer requirements and also to avoid costly recalls. Each and every automotive material and component should be going through extremely thorough and careful testing to meet industry and legal requirements. Usually automotive component manufacturers are ISO 17025 accredited.

How LIMS helps during automotive testing?

1. Sample Test Specifications

• Parameters that need to be tested
• Characteristics of parametric values
• Instruments needed for testing

2. Standard Operating Procedures

• Skills needed for testing
• Process involved
• Make SOP available during testing

3. Training Needs

• Training matrix of Test Analysts
• Compliance with industry Standards
• Evaluate training needs regularly

4. Sample Receipting

• Receive Samples from various teams
• Assign Sample ID and automate barcode generation
• Alert appropriate Managers of the receipt

5. Sample Scheduling

• Calendar display of Sample analyses
• Allow priority based changes

6. Instrument Scheduling

• Calendar display of instrument usage
• Avoids conflicts

6a. Instrument Calibrations

• Maintains complete calibration records
• Alerts on pending calibrations
• Make available only calibrated instruments

7. Sample Analysis

• Collect data from analysis based on specifications
• Provide immediate alerts if parameter values are OutOfSpecification
• Alert management for approval samples analyzed

8. Reporting & Certificate of Analysis

• Immediate access to management reports
• CoA for all samples
• Historical records availability for future

Takeaways

• Improved 360 degree view of sample flows - receipting to analysis to results
• Compliance with regulations
• Streamlined flow of processes
• Objective data for management
• Objective data for customers on sample analysis - Internal or External

Please reach out to support@codonlims.com for any specific questions on how CodonLIMS can become a valuable cog in automotive component quality analysis flow.

Air quality can affect every individual and could manifest in either short term or/and long term illnesses. This topic garners more significance in and around industrial neighbourhoods to monitor particulate matter that is part of air.

Because of the health concerns there are effective compliance regulations defined by local environmental government bodies for maintaining air quality.  It is very important to understand air quality standards and objectives to manage key air pollutants and how they could affect health of humans and as well as the environment. The compliance requirements should be followed by industrial establishment to make sure the pollutants are actively monitored and are within limits.

How should it be implemented?

Monitoring of air within industrial premises becomes important based on the processes and the manufactured goods. The air sampling needs to be monitored across the organisation - inside and outside to make sure there are enough samples collected to make it effective. As we all know air quality is not same everywhere ... it gets bad within enclosed spaces based on the manufacturing processes and the emissions. It is very important to monitor 24x7 to be able to understand and mitigate the effects if certain hours of the day the quality goes down.

Monitoring and Sample Collection

There are multiple ways of collecting air samples:

• Automated Systems
• Passive Diffusion systems

We will focus on passive diffusive systems because of couple of reasons - they are inexpensive and can be placed across wide area. They are placed in areas where there is good sample of air passes through the material. Typical sample collection happens with high volume samplers and respirable dust samplers. The filter paper that is used as part of sampling can be used to determine metals, sulphate and nitrate levels.

Specifications

This is very important aspect of implementing effective air quality monitoring within industrial premises. The QA teams actively interact with governmental agencies to specify the limits and the processes that need to be followed while performing analysis. These specifications can be reviewed yearly or other timelines based on internal policies or governmental regulations.

LIMS helps in maintaining the specifications and Standard Operating Procedures on a central server and facilitates the access during analysis and is available for review across organisation.  These specifications also would contain details on Out Of Specification (OOS) and Out Of Trend (OOT).

Typical pollutants to look for:

• Sulfur Dioxide
• Carbon Monoxide
• Nitrogen Dioxide
• Metal traces
• Others

Analysis

The collected samples are then passed to Quality Control labs either On-Premise or 3rd party for determine the particulates of air to pro-actively come up with plans to combat the particulate matter that could be hazardous.

Sample Analysis WorkFlow:

1. Filter cassette samples are retrieved
2. Filter paper is removed from Filter Cassette
3. Filter paper is digested with acid to prepare liquid samples
4. Sample Request is raised on LIMS for analysis
5. QC team transfers the samples to AAS for getting the particulate matter quantities
6. Data from AAS is retrieved into LIMS
7. LIMS automates calculations and provides final results of the analysis to the teams

LIMS forms an integral part of analysis in alerting analysts of the samples that are waiting to be analysed and the required tests that need to be performed based on the defined specifications. Provides the list of consumables/reagents with the quantities needed while performing analysis. There could be a need to use AAS (Atomic Absorption Spectrophotometer) to collect details of particulate matter that are part of air sample. LIMS will make sure the instrument has proper calibration records and automate the data transfer from AAS to minimize data entry errors.

There are few calculations that need to be performed as part of final reporting for internal and external agencies. From sample receipt to report generation can be automated with LIMS deployment.

Usually the government agencies would require analysis reports that explain trends of air sample particulates. These reports need to be constantly monitored by organizations to implement proper mechanisms to improve air quality within and outside organization premises.

What can be done to improve Air Quality?

Actively monitoring air quality with proper analysis and making pro-active efforts is need of the hour. Within industrial establishments:

• by continually bringing down affecting effluents or any other pollutants that could decrease air quality
• By increasing green cover by planting trees which would be very useful in curbing harmful effects of offending pollutants
• Investing in newer technologies as part of production processes and cutting down on fossil fuel consumption

This system provides options to track availability, expiration, usage and their respective work performance records in a secure and convenient package. With the help of this information, the management can reach the annual goal with low-cost efficiency and an effective outcome.

Why

By using the Consumable Management System, the management can track and prevent issues at the time of Research and development (R&D) or Manufacturing as mentioned below:

Availability and Expiration

Inventory related issues such as shortage of samples, non-availability of certain inventory items or the items in stock having reached their date of expiry, could cause huge losses to the production house in terms of both money and time along with a delay in the product delivery. Through CodonLIMS the availability and expiration of items can be tracked by the user through dashboard and email alerts as shown in the images below:

Usage

The management can track the inventory usage, making their availability visible. This information can help the management reduce wastage of their dead stock or overstock inventory which in turn will reduce the wastage of money. Usage tracking can also be done in the form of auditing. Through the usage tracking facility provided by the CodonLIMS application, the user can easily track the usage of inventory. They can find out or track the usage quantity and whereabouts of the inventory item at a given stage or test in production or R&D as shown in the image below:

Data Security

Authentication and authorization play a prominent role here. Only authorized users will be able to access the data related to inventory and consumables. They can also book or approve requests based on the role and permission accorded to the particular user. All important data like Purchase order (PO), validation reports and Certificate Of Analysis (COA) of suppliers can be stored safely and can be used for future reference.

Reference Records

Reference records are maintained for historical reasons. These records are approved by conducting tests or R&D of previous batches and should be stored in the system for reference in the future as required. Typical reference records include test results, Standard Operating Procedure (SOP), Standard Test Procedure (STP), COA reports or Analytical Test Data Sheet (ATDS) reports. These records help the user to validate the future lots or batches that get supplied to their organization.

CodonLIMS provides a platform that helps store and organize the data of inventory and alerting the management accordingly across different locations of the plant, based on the requests and approvals given by the users based on their roles.

It is important to conduct Measurement of Uncertainty for Labs that is engaged in Pharma Industry to ensure the lifesaving products are produced to highest quality with Zero Defects.

Considering the importance for reliable measurement, ISO released ISO/IEC 17025 standard that talks about General requirements for the competence of Testing, & Calibration Laboratories that includes Evaluation of Measurement Uncertainty (Clause 7.6).

And ISO 21748 standard provides Guidance for the use of Repeatability, Reproducibility and Trueness estimates in measurement of uncertainty evaluation.

3 factors viz. Trueness, Repeatability and Reproducibility play major role in the evaluation of Measurement of Uncertainty. Let us understand how these 3 can affect the quality of results.

Trueness

Trueness is the measurement of known standard reference sample and how close is the measured result. If the difference is beyond the allowable limits (published data), it is not advisable to use that instrument/equipment for testing or calibration. While the error can be addressed thru calibration, it is not recommended to use the ones with correction factors for calibration purpose.

Repeatability

Repeatability is the measurement under same test conditions that includes same operator, same instrument, same test conditions and studying the variations among the measured results.

Reproducibility

Reproducibility is the measurement using the same instrument but can be different operators and different location/test lab. Sometimes, the samples are measured in the process line instead of lab.

With high Repeatability, one can achieve high Reproducibility by ensuring robust test procedures & operators competencies.

Using the above data for an instrument/test equipment, the measurement of uncertainty can be arrived by comparing with published standards.

Once the uncertainty levels are arrived, one need to multiply with Coverage Factor (k) as per Industry requirement to report expanded measurement uncertainty for higher confidence of quality results. The Coverage Factors used for 95% confidence level is 2 and for 99% is 2.58.

CodonLIMS provides platform to capture the measurement of uncertainty data for each instrument / test equipment along with final uncertainty range. This data is made available when using instrument for any measurement and the results can be shown along with the uncertainty range.

Good Manufacturing Practices (GMP) is a system that ensures manufacturing products such as food, cosmetics, and pharmaceutical goods which are consistently produced and controlled according to set quality standards. GMPs examine and cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling. Implementing GMP can help cut down on losses and waste, and protects both the company and consumer from negative food safety events.

What are GMP Guidelines?

GMP guidelines are a set of principles that help manufacturers implement an effective manufacturing process and ensure that quality is built into the organization and the processes involved. GMP guidelines are customarily flexible, with countries having their own legislation to comply with local GMP guidelines and principles. But almost all regulations are derived from the basic concept and guidelines which are explained as Good Manufacturing Practices (GMP) .

12 G's of GMP

1. Good SOP:

Standard Operating Procedures are issued to instruct employees in areas of responsibility, work instructions, appropriate specifications and required records. A Good SOPs are the documents which helps the employees to work efficiently on the task which were allocated to them with having minimal errors.

2. Good Methods:

Good methods are very useful for the manufacturers where they can use them at the time of manufacturing the product without any defects are faults. Basically, in pharmaceuticals, methods are nothing but tests which are used to test the product at the time of manufacturing.

3. Good Hygiene:

Your personal hygiene is very important. All personnel working in the production area are expected to maintain a high degree of personal cleanliness. The following things that a manufacturer has to make sure that are Personal hygiene, cleanliness, handling of the products, illness and injuries, Cross-contamination etc.

4. Good Records:

These records are the only real source of information on a batch after it has been released or the time of production for inspection purpose too, so they must be accurate and complete. They provide legal evidence that the company followed GMP.

5. Good Vigilance:

Keeping an eye on the each and every operation done by the employee or the results of the operation makes us to eliminate the errors of the products mostly. All these operational vigilance can be done by the superiors, in the form of approvals.

6. Validation:

Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. It may be either Vendor Validation or Performance Validation etc.

7. Good Training:

Effective training programs always impart responsibility in all employees to perform their tasks with utmost care and commitment. In the healthcare manufacturing industry each employee needs job specific training in technical skills, SOPs, and awareness of the GMP. To satisfy this requirement, companies must adopt a systematic approach to training design, development, and implementation. Training helps the pharmaceutical industry to meet the compliance, consumer safety, product quality and to their development.

8. Updates:

As in the part of vigilance, each operation can be given as update to the superiors, which helps us to eliminate the errors at the very first stage itself. Those should be done by getting time to time alerts in the form of emails, or dash board alerts are sending for approvals will do.

9. Good Machines:

The quality of the manufactured product depends on the suitability, and level of the technology of the equipment used. Since, it is major requirement in the manufacture of the pharmaceutical products. The Efficiency of the equipment can be maintained by giving time to time services, calibrations and doing performance validations of the equipments.

10. Good Materials:

All the materials which are used in the pharmaceutical industries should pass the QA. On second hand all the materials should be monitored time to time to avoid using of the expired materials at the time of production and also maintain a good stock, which avoids the situations of running out of stocks which delays the production.

11. Good Facility:

To provide a good manufactured product, the facility also plays a prominent role. As the organization should built the facility which is suitable for the production like, labs, culturing rooms, equipment rooms and also should maintain the premises clean and tide, which avoid cross-contaminations etc.

12. Good People:

The GMPs for a manufacturing facility must be strictly adhered to and this cannot be done without proper GMP training for personnel. All people involved in making a drug must have clear roles and responsibilities. Employees must know how to follow procedure and their performances must be assessed. This also means that the training methods must be reviewed, so that manufacturer knows how it can ensure their employees are properly trained and competent.

CodonLIMS has all the above mentioned 12 G's of GMP seamlessly and maintains the data for GMP compliant facilities.

Environmental Monitoring is defined as the observation of the presence of harmful factors such as toxins, bacteria, chemicals and other pollutants in a specific location.

In other words Environmental monitoring describes the processes and activities that need to take place, to characterize and monitor the quality of the environment. Environmental Monitoring is a surveillance system for microbiological control of clean rooms and other controlled environments. It is a process which provides monitoring, testing and feedback to the microbiological quality levels in aseptic environments.

Environmental monitoring in microbiological testing plays a critical role in ensuring the safety of patients and the efficacy of drugs and biologics by preventing their contamination with microbes. Microbiological testing alone does not provide complete or absolute assurance of absence of microbial contamination but helps to ease the process of investigation of microbes which are present in laboratories or manufacturing units.

Basic Environmental Monitoring Tests in pharmaceuticals

Active sampling - Air sampling is a method used to find out what airborne contaminants are present in your environment. Air is collected by using various methods and then, it is tested for the presence and concentration of hazardous substances and microorganisms.

Passive Sampling - Passive air sampling basically involves leaving settle plates or contact plates exposed to the air for a certain period of time to collect microbes that may settle onto the surfaces of the plates.

Surface monitoring - Surface Monitoring is a method used to find out what airborne contaminants are present in your environment. The samples are collected from the surface of the lids, which are placed for some period of time at a certain environment and those lids will be taken for testing.

Personnel Monitoring - Personnel Monitoring is a method used to find out the microbes from the person who exposed or worked any radioactive conditions for a certain period of time.

Workflow of Environmental Monitoring

Where: Environmental Monitoring will be carried in manufacturing areas, like pharmaceuticals, Cosmetics, Researching Laboratories and desired locations.

When: Environmental Monitoring will be done based on the manufacturing areas rules and regulations. For example, if it is a Battery manufacturing unit, then every week twice the EM will be done to check the Lead levels of the environment. Likewise the EM will vary from Location to location and Weather Conditions too.

Personnel monitoring will be held when the operator leaves the process area. This type of monitoring will be done very frequently.

What: In Environmental Monitoring, the environmental properties like, soil, air, water will be tested for their environmental conditions, getting the accuracy of the particular area will help to provide sterile and suitable conditions for running the production smoothly.

Who: The Well trained Microbiologist trainers will perform the End to End Environmental monitoring tests. These trainers must and should get trained on the instruments which are going to be used in performing the environmental monitoring tests because, the results are very crucial for production.

How: As per the current practices, there are SOPs and ISO documents which will guide and define the procedure to follow and perform the Environmental Monitoring. The trained Microbiologist will perform the Monitoring process accordingly.

Some of the Guidelines are listed below for reference

• The U.S. General Service Administration's standards (known as FS209E) Global clean room classifications and standards were adopted by the International Standards Organization (ISO).
• ISO-14644 The first Federal Standard 209 published in 1963 Revised in 1966 (209A), 1973 (B), 1987 (C), 1988 (D) and 1992 (E), and withdrawn in 2001.
• By law, Federal Standard 209E can be superseded by new international standards. It is expected that 209E will be used in some industries over the next few years, but that eventually it will be replaced internationally by ISO 14644.

CodonLIMS provides platform to capture the data of Environmental Monitoring parameters across multiple locations of a plant. By using the data collected based on predefined tests, CodonLIMS can generate reports to help understand on-ground situation and take precautions accordingly for smooth functioning of production facilities. Two typical report are enclosed for reference.