Express Pharma

The monster in your laboratory

6

Sekhar Surabhi, CEO and President at Caliber Technologies, insists on paperless automation and recommends a shift to a completely automated, paperless laboratory

It is eating up your time and effort. It is resulting in a compromise on your efficiency. It is taking up all your space. It is putting you under huge risk of data loss and non-compliance. It is putting you under huge risks. To add to all this, it is making you falter in front of your auditor. There is a monster in your laboratory. Paper!

Though environment is one of the lesser considered factors while addressing pharma challenges, a simple web search will tell you how paper is affecting the environment. Collectively known as paper pollution, it is causing deforestation, air pollution, water pollution and to some extent, damaging the planet. Due to the increased usage of paper, paper mills have begun to contribute all the more to the world’s pollution. The production of paper itself contributes to most of this pollution, leave aside the over-usage and consequent wastage of resources after said production. An interesting fact I came across recently is that the pulp and paper industry is fifth in the list of worldwide largest consumers of energy, thus taking up four per cent of the world’s energy usage. As the worldwide consumption increases year after year, this paper pollution continues to be a threat to the environment. To sum up, paper usage is hurting the greenness of the planet. Laboratories that use piles and piles of paper are ending up wasting the opportunity to make a difference to the planet by continuing to use paper even while superior paperless automation options are readily available in the
market.

Having said that, my case is not just about the environment. It is for your laboratory. Paper is not doing any good for your laboratory either. It is affecting your time, efforts, efficiency, quality, data security, data sanctity and unarguably, regulatory compliance.

Time and effort

Constant dependence on paper for recording analytical testing and associated tasks is resulting in a laboratory that is unable to function at its highest capacity. 26 per cent of the precious time of lab personnel is getting wasted in writing and re-writing transcriptions. Having to fill in the same details manually over and over again, and physically passing around sheets of paper for approvals seems archaic. With transcription of the data from lab books or instruments, manual calculation verification, data review and approval, most of the supervisor’s time is wasted in verification, which has no value addition from him/ her to the system. This results in a sheer wastage of efforts and time.

Efficiency

In a world that changes every second, compromising on efficiency is not a negotiation. The law of ‘Survival of the Fittest’ applies to everybody and is a well-known fact known. Being your best comes from using the best resources and applying the best efforts into making a truly excellent product. Upgrading to technology and building more opportunities to do better is an endeavor every business must envision. With paper, your processes continue to eat up the efficiency of your laboratory. Re-works and re-checks caused by manual errors become a hindrance to productivity and in turn, your laboratory’s efficiency gets affected. In an automated world, efficiency is a natural outcome, not an effort.

Quality

The foundation for quality in GMP has been the 4M Rule – Man, Machine, Method and Material. It is the fundamental rule of GLP (Good Laboratory Practices) that if these four resources are controlled and used in the way they need to be used, quality of the analytical testing is assured, thereby assuring the end quality/safety of the medicine supplied. Controlled resources are a direct result of a mixture of many processes done right – qualified analyst to perform specific tests assigned to him/her, calibrated status maintained instruments, testing method for the analysis being performed and all associated material like chemicals, volumetric solutions, standards, columns, micro cultures, etc. More than 29 per cent of the non-compliances found in quality control laboratories are due to improper controls or such controls being circumvented. These issues generally happen in paper-based quality management and many of such issues are consequentially solved
and enforced in the automated systems.

Data security and sanctity

Data security and sanctity is also one of the major concerns with paper. Storage of crucial laboratory information on paper, which is open to the risks of damage and loss, is a burden that a laboratory must carry in the absence of technological intervention. Data archival, preservation and retrieval is least optimum with paper. Also, with humans at the other end of this piece of paper, errors and even frauds, are a risk that an organisation must be willing to take. Manipulation or error could thereafter result in multiple issues which may affect the quality of the product, regulatory compliance, and even your profitability. How much can all this cost you is a calculation that I know you can make better. With an automated system, all information is stored in a system at one place and can be retrieved whenever needed. Only authorised persons can access data and every movement in your data can be easily tracked. A smooth audit trail is made which makes it effortless to point out an error or manipulation. An automated system can provide
the kind of security that paper just cannot.

Regulatory compliance

Risk of non-compliance could be one of the biggest risks in pharma. Even if you are willing to ignore the effects of paper as argued above, regulatory compliance is an aspect a laboratory can absolutely not afford to compromise on.

ALCOA – recent guidelines for data reliability and integrity, issued by UK MHRA and US FDA is one of the prime drivers for automation in order to achieve compliance. Every piece of lab information/action recorded should comply to ‘Assignable, Legible, Contemporaneous, Original, Attested copy.’ Also, with FDA insisting on electronic filings and audits, it is imperative that your laboratory shifts to an automated setting.

It must also be noted that amongst the 483s published, 69 per cent are due to non-compliance from QC. A further drill down shows that these pertain to procedures, controls, transcription errors, etc. A paperless system is a much easier way to control these issues. Automating procedures, workflows and documentation will result in significantly lesser need for review and supervision. This will also drastically bring down audit comments with respect to errors and procedural irregularities.

With stringent rules from different regulatory bodies, it is crucial that your entire working system is robust. Systems must be designed in a way that these regulations are met by default, hence ruling out the need to revisit each procedure to ascertain if they meet the conditions put forward the by these regulatory bodies. A completely automated, 100 per cent paperless laboratory.

Quite perceptibly, taking the leap to completely get rid of paper is intimidating to a laboratory of any size. However, a company envisioned this and approached us in 2014 asking for a completely paperless laboratory. While most of our counterparts offer only partial automation, this client asked us for a 100 per cent paperless laboratory. We took up the challenge. The solution was a scalable, hosted and integrated solution ensuring high data integrity and data sanctity. Hence, we implemented our LIMS (CaliberLIMS) – Laboratory Information Management System in their laboratories across India.

The result was a 100 per cent paperless laboratory (first of its kind) with complete automation of every task, minimum scope for human intervention and zero dependence on paper. All processes were made completely automated. For example, this system facilitated sample logins and sample registrations with complete automation and controls; sample results approval and certificates could be generated online; label printing and barcoding was programmed within the system; online review process by multiple levels of supervisors was made possible; etc. This solution was designed in a way that the laboratory adhered to international quality standards like GLP, GMP, 21 CFR Part 11, and 17025. All systems and instruments were integrated with our software to ensure smooth flow of processes. In addition to this, our solution came with a built-in ELN – Electronic Lab Notebook. As a result, the audit observations drastically came down, and it improved the efficiency manifold, also creating a secure database for all laboratory decisions and processes. All this was possible by making a definitive resolve to go paperless.

Automation is not just a trend to follow, it is indeed a real need – and it is undoubtedly achievable. So, get rid of that monster in your laboratory.

I urge you, not just for the sake of the planet, but for the sake of your own time, efforts, efficiency, data, risks, and compliance, make the shift to a completely automated, paperless laboratory.

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