- Due to increased regulatory compliance in the pharma manufacturing industry, Clinical laboratories are feeling the pressure to ensure GMP compliance while balancing the productivity demand on the other side.
- Handling large sample sets successfully and automating the workflows of complex multi-step processes will significantly increase productivity.
- It will also help us to introduce advanced innovative technologies on stream for molecular diagnostics.
- It is challenging to find a flexible liquid handling automation solution which satisfies all the present and future needs of the industry. It should be fast and can be integrated easily into the existing system.
Let us look into the key considerations for implementing the automation platform in the GMP regulated environment.
Flexibility should not compromise quality and accuracy
New assays and novel strategies that rely on a combination of diagnostic methods and innovative techniques and technologies are challenging the traditional methods of clinical labs.
Labs have developed their own test methods specific to some patients and applications such as immuno-oncology etc.,
A flexible open GMP Compliant System offers several advantages including the abilities below.
- Run no of assays at the same time and get integrated test results across multiple tests to reach a diagnosis and relate the results from upstream to downstream assays.
- Introducing new technologies into clinical tests with complex workflows and sample preparation procedures.
- Conducting rare assays and one-time laboratory-derived tests(LDTs) under a compliant environment
With the increase in flexibility of the automation system, there is a possibility of a broad range of assay types and configurations. Qualification and process validation become more and more difficult. There is also a risk of human error at every stage of design and setup of assay and through to results interpretation and documentation.
Keeping all the above risks associated with the flexible automation system, still, the potential benefits of automation outweigh the risks. The ideal thing to do is to select the platform which offers the best practice of GMP under the regulated clinical environment.
It is very important to select the right automation platform before implementing it in the GMP regulated laboratory as there is too much at stake. There are a few factors which needs to be considered while making this important decision
- Compliant Check – While bringing the new system or instrument into the lab for clinical diagnostics, non-compliance issues during the validation process will become costly and cause unnecessary delays in the process. Compliance should be at the top position of your checklist. Choose the manufacturer with sufficient knowledge and understanding of the clinical environment and can offer automated solutions which can be readily used in the GMP labs. Ensure that the system is fully compliant with global regulatory requirements.
- Audits – Hassle-free and a smooth audit trail is one of the important requirement of the clinical laboratories. A good Automation system should automatically capture and document all the relevant and important data related to system access, user management and electronic records ensuring data quality and security.
- User management – Many different people will handle the test samples in the lab. It is essential to track the timings and users using the system. The user management system should enable multi-level user authentication by defining administrator roles and users. It should prevent unauthorized access by enabling password protection depending on ageing and complexity.
- Sample ID & tracking – Efficient sample identification is one of the key factors in regulatory labs to avoid the mix up of previous samples. Barcoding of each sample is the best way to track the samples from sample preparation to reporting of assay results. A solution which has built-in barcoding system and tracking system will help you to manage samples, processing and data handling.
- eSignatures and records – This software should automatically detect and prevent alteration of records with the help of passwords and enabling additional user authentication steps. User must be made to provide an appropriate description whenever he is making a change to an electronic record.
- Minimizing human error – Due to the frequent changes or modifications in the protocols, the introduction of new assays and workforce turnover, system handling will not be easy unless it is user-friendly as much as possible. Such user-friendly interface with visual feedback lets people of different technical capabilities run the system without much difficulty. A new user can quickly learn and become skilled operator on user-friendly systems.
- Interfacing with LIMS – A new automation solution in your lab should be able to interface with your existing LIMS system. It should be able to cope up with the Changes in your LIMS solution. Ensure that the database containing sample tracking data and results can interface directly with the common commercial LIMS.
- Accurate & reliable – In Clinical environment, you cannot afford to compromise on quality, Being flexible you should also be fully compliant. Your automation solution should be able to deliver accurate test results, precise liquid dispensing consistent performance across different assay panels.
- Compliance-ready solution – Clinical laboratories can get a competitive edge with an Automation solution offering advanced technologies in diagnostic testing. Meet the demands of the existing market without taking unnecessary risks by opting to a Compliance-ready solution with the following features
- Process more samples faster and cost-effective
- Expand the introduction of new complex assays and testing methods
- Manage the changes in the regulatory environment.
An experienced vendor of automated gmp compliant systems can provide you with the appropriate compliance-ready automated solution and can also offer additional support to meet your present and future market needs.