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Paper Today, Glass Tomorrow

Recent years have seen a set of clear trends in the pharmaceutical industry, many of which are the result of an increasingly strict regulatory compliance framework for pharma manufacturers. Two of these trends in particular – industrial automation and the move from paper to glass – have allowed manufacturers to gather, monitor and analyse data, while also achieving better transparency and regulatory convergence than ever before.

In terms of R&D, the pharma industry leads the way because of its use of new, innovative technology. However, when it comes to business management, many companies still find themselves buried under mountains of paper. While regulation and compliance requirements historically drove these companies to work with paper, advancements in digital tools mean this is no longer the case. Unfortunately, once paper-based systems are in place, they can be difficult to eradicate. Companies become stuck in their ways, which leads to them ignoring the significant cost savings, efficiencies and competitive advantages electronic systems can provide.

Accuracy and Productivity

An automated electronic batch record or document compliance system is able to complete programmed tasks the same way every time. Unfortunately, humans are much more susceptible to errors than machines, which could affect performance when entering records. Bad handwriting, sleep deprivation and attention lapses are all human issues that automated systems are free of.

The most important driving force for a company's success consists of its employees. Providing them with a familiar interface that quickly connects them across the organisation allows staff to work faster and smarter, therefore increasing productivity. Electronic records also eliminate time-consuming and error-prone data entries that are necessary with paper-based systems.

Save Resources

A typical pharma cycle time falls somewhere between 30 and 90 days, with batch releases alone taking up to 60 days (1). Typically, these cycle times double in non-conformance scenarios. Digital records enforce the consistent execution of each step in the manufacturing process, while providing an accurate, real-time view of process data. Electronic systems also help eliminate the wasted time associated with detecting, tracing, correcting and documenting deviations in the manufacturing process.

The biggest cost of manual processes comes from people. It costs companies both time and money to perform tasks that could be automated and streamlined using technology. Human errors that occur during manual processes can result in redundant actions, rework and audits too. Electronic records also eliminate the costs associated with printing, reviewing and retrieving paper documents.

As pharma companies grow, they have to cope with increasing volumes passing through their business processes. In addition, they have to adapt to the process or procedure variations that come with different types of customers, orders, products and suppliers. If the business is still using paper-based records, this complicates the filing system and can cause a huge increase in records.

Manual and paper-based processes store data in a disconnected and difficult-toaccess manner. Paper documents can be difficult or even impossible to find. This can delay processes such as decision-making, as companies end up spending a lot of time getting data into a consistent, usable format. Due to the costs associated with gathering data, many companies choose to forego it. Unfortunately, this decision can lead to companies making uninformed and often incorrect choices further down the line.

Taking the Leap

Considering the benefits, it is hard to believe that some pharma manufacturers are still operating using paper documents to manage business processes. Companies may be hesitant to switch because detailed planning is necessary for a smooth transition. The initial change can also be costly for a facility – as both paper-based and electronic records have to be kept for a while. It is also important to consider the costs of designing and integrating interfaces, including staff training and product development. Having a detailed plan in place allows facilities to manage their time effectively.

Regulatory Compliance

Not only do electronic records simplify companies’ processes, they also help businesses comply with regulations. The FDA 21 CFR Part 11 regulation defines the criteria under which electronic records and signatures are considered trustworthy, reliable and superior to paper records. Although the procedure can seem overcomplicated to drug manufacturers, the regulation is easy to embrace by using the correct software.

The collection of electronic data must adhere to strict guidelines. To comply, organisations should link electronic signatures to the records and record all activity in an audit trail. Security measures must also be in place to restrict access to systems in the regulated environment.

Software products themselves cannot be certified; only the products, processes or projects of a company can be validated. Using electronic records allows companies to document each operation and event. In the pharma industry, when a mistake does happen, manufacturers must be able to reconstruct the complete history of events and processes using the audit trail.

In the case of paper batch records, mistakes can usually be traced back to missing entries or incorrect records. Industrial automation software and hardware can simplify the process of logging, archiving and reporting on information from a variety of sources including mobile devices, especially where the audit trail is concerned. Companies should automatically log any modifications and events during the production process, which ensures secure traceability of all system and operator actions.

Process flexibility and validation efficiency cannot be achieved without accurate audit trails, alarm management, user administration, structured query language and reporting. User administration regulates who can have access to this closed system, restricting usage to authorised personnel with usernames and password verification. To comply with this regulation, good software automatically records unsuccessful login attempts and applies system lockouts to all information when unauthorised access is requested.

Technological Advances

The move from paper to glass has not yet happened across the pharma industry, despite the increasing availability of smart industrial computers and control systems. Technological advances such as mobile devices, usability and big data all contribute to the move towards digital in the pharma industry.

Mobile and tablet usage is paramount for paper to glass applications. Paper is portable, so the medium that replaces it must also be transportable. Companies should use server infrastructure to safeguard process information. If the tablet is lost or broken, the data needs to remain secure.

Usability is also of significant importance, since mobile tablets generally do not have large screens and a pharma system contains a lot of information. Intuitive presentation and multi-touch functions are essential in linking users to a known interface common to tablets and smartphones.

Similar to other major industries, the pharma sector is learning how to use big data to become more effective. In healthcare, electronic medical record data is being combined with genomic and genetic data, financial data and patient-reported data to deliver insight into which treatment provides the highest overall value to patients and healthcare systems at the lowest cost.

Pharma companies will need to collaborate on this front, as well as use targeted data to improve areas such as drug development, meet the needs of insurers and provide compelling evidence of a drug’s benefits.

Within the industry, there is a continuous movement towards cloud computing within R&D. To date, the cloud market has mainly served as a tool for sales and marketing teams within most pharma businesses. However, the cloud is now adapting to meet the needs of all areas within life sciences and can be particularly helpful in overcoming intellectual property and security issues. It has also allowed many companies to cut down on operational costs.

In Progress

It is fair to say that some pharma companies have already started the transition from paper to glass, but it might not be a full implementation. The benefits associated with using digital platforms to manage business processes are extensive. Not only does the transition save money, increase productivity and strengthen accuracy, it also helps companies comply with the latest regulations, making the storage of documents easier and more secure.

While the switch from paper to digital is a big commitment, having a detailed plan in place ensures a smooth transition. Getting the team involved at every level of the company also means that, once implementation is complete, staff will be more willing to partake in training and make full use of the new digital tools.

Reference
1. Jacobson S, Fending off the FDA – Adopt an integrated, enterprise-wise cure for your quality managementailments. Visit: www.qualitydigest.com/mar08/article/02_article.shtml

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Darren Halford is Global Sales Director of Obsolete Components Supplier at European Automation. Previously, he worked as a Recruitment Consultant, recommending new employment opportunities to senior construction professionals. Darren oversees all sales and service operations and has been with the company since its inception in May 2009.
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