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mapp FDA 21 CFR Part 11

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PHARMACEUTICAL AUTOMATION Addressing regulations in the pharmaceutical industry

Dec 13, 2018

With stringent laws being set by the US FDA, it is increasingly important for the pharmaceutical sector to be compliant with standards designed to enhance product quality. This article explores the regulations and the ways they can be implemented within a pharmaceutical enterprise.

Everyone in the pharmaceutical industry is well aware of the stringent laws and standards being set by the US Food and Drug Administration (FDA). The US FDA is responsible for the safety and efficacy of medicines and food products. It has comprehensive laws and regulations for the pharmaceutical manufacturing practices to ensure quality, purity and safety for individuals. Sometimes, the smallest deviation from standards can result in entire batches being rejected or recalled after they are out in the market. In grave circumstances, a company’s license could be at stake.

Compliance with standards allows pharmaceutical companies to enhance product quality and meet standards. All these stringent requirements require pharmaceutical companies across the globe to examine data at every stage of the manufacturing process, right from the time raw material arrives until the final product is packed and shipped for distribution.

In many ways, data quality is extra important for pharmaceutical companies. After all, mistakes in this industry can literally be fatal. In traditional pharmaceutical facilities, the references and information about drug formulation, production, equipment and data of QA-QC were manually entered in data sheets, which were prone to human errors or could stand a chance of manipulation. The pharmaceutical industry needs accurate and reliable data to ensure safety, efficacy and quality of products. FDA has answered these challenges with 21 CFR Part 11 regulations.

Benefits of 21 CFR Part 11

The 21 CFR Part 11 regulations allow pharmaceutical companies to use electronic records and signatures in lieu of paper records and handwritten signatures for documentation. Several benefits of compliance were identified by the pharma industry in terms of data authenticity, increased speed of information exchange, cost savings from reducing storage space, reduced errors and data mishandlings, product improvement, streamlining manufacturing process, improved process control and reduced vulnerability of electronic signatures to fraud and abuse.

The execution of 21 CFR Part 11 might look costly as well as might require a lot of work but this has definitely standardised the process for electronic records. The early adoption of this regulation can lead to more efficiencies and productivity within organisations. Eventually, this regulation can also reduce products’ time-to-market and increase traceability, which is better for manufacturers, distributors and consumers.

Making audit trails easy

As the use of automated processes has become more prevalent in the pharma industry, so has the use of electronic records with the introduction of 21 CFR Part 11. B&R’s automated solutions directly addresses all regulations prescribed by 21 CFR Part 11. The company satisfies FDA requirements by its range of hardware and software that are fully compliant with FDA 21 CFR Part 11 regulations.

With mapp Technology, B&R provides customers an addon package of technology libraries that support all FDA criteria for electronic records and signatures. Data security, data integrity, traceability and electronic signatures are a few basic requirements of this regulation. It thoroughly addresses these requirements of security by restrictive access to data through mapp Technology. It allows different levels for access control, so that users can only access data that is at their assigned level.

Applications subject to FDA’s 21 CFR Part 11 requirements can be developed faster and with less investment risk using mapp audit. All user actions are logged with a timestamp and username. The data can be exported as an encrypted PDF. It has the ability to re-trace actions performed on a machine, which can also be of great service to its manufacturers in the event of warranty claims. Pharma companies demand the ability to log operations performed by users seamlessly without the risk of being tampered with. B&R’s mapp audit component serves as a quick & easy way to implement and customise necessary audit trail functionality.

Automatic data exchange made possible

Designing audit trails can be difficult and time consuming. However, with mapp Technology, there is no need to write programs for audit trail function; all that is needed is to configure the machine-specific parameters. Thus, mapp technology enables users to configure more and program less, with mapp audit eliminating the need for writing lengthy programs for audit functions. Machine builders only need to configure the machine-specific parameters. The data can be output in an encrypted file or viewed on the HMI screen, using the integrated mapp audit visualisation. The audit automatically retrieves information it needs about operators from mapp user component, using the client-server principle.

Audit trail data is then stored in memory with a mechanism for tamper resistance. It enables pharma machine builders to review operator activity in order to determine whether a system has been used appropriately. It is equally possible to determine whether equipment has been used outside the specified operating times – an indication that employees are engaging in unauthorised production for their own profit.Audit trail data is then stored in memory with a mechanism for tamper resistance. It enables pharma machine builders to review operator activity in order to determine whether a system has been used appropriately. It is equally possible to determine whether equipment has been used outside the specified operating times – an indication that employees are engaging in unauthorised production for their own profit.

Revolution in automation software

The advances in software offers integrated approach to pharma machine builders to achieve operational excellence, increase effectiveness, comply with ever-increasing regulations, improve time-to-market and meet business goals. With mapp technology, B&R offers modular software components that handle the basic functions of any pharma machinery and equipment.

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