In Pharmaceutical industry main focus is producing qualitative and efficient products that are benefiting patients. While many companies are competing with each other with products, innovative technology, ways of manufacturing and supply chain management business processes, one thing unites them all. In one step or another all companies are performing paper “write-ups”.
For many years company’s each product success “formula” was recorded and maintained on paper, yet innovative technology is driving major advancement in paperless world seeking improvements and benefits. While in compliance with regulatory requirements, many organizations are still working with paper-based systems, others have taken new innovation challenge and are successfully (or not so much) operating with paperless system.
What is this success “formula” of the company that can be maintained on paper or electronically? This is traditionally used paper (hard copy) to maintain production/manufacturing batch record (MBR), where all activities are documented according GMP and regulatory requirements and/for compliance. Electronic batch record (EBR) is its prototype that is maintained by software system which came with changes of 21CFR Part 11 in 1997 when FDA began to accept electronic batch record systems.
Let’s take a look on how different two systems are:
It’s obvious that paper-based process takes time, effort and space to manage and to be maintained. It involves risk of human errors with regards of entries on multiple forms and signatures which indicate compliance with many steps needed within manufacturing and process area. This data typically undergo a “first review” on site and then a quality review when batch is completed. Raw materials and finished goods...
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...s used independently providing staff with necessary experience and knowledge through the transition until the electronic batch records is fully employed. Now electronic batch record manufacturing system is operational and the benefits of productivity enhancement, quality improvement and cost reduction can begin to be optimized.
Transition to paperless manufacturing can be challenging. Employee pushback, inadequate or incomplete identification of requirements and system validation can put systems and processes at a higher risk of failure. However, the competitive advantages and benefits offered by the use of Electronic Batch Records in pharmaceutical manufacturing are real, significant, and too well designed to be ignored. When properly implemented and integrated, Electronic Batch Records can help companies increase profitability and maintain a competitive advantage.
The American Red Cross, a non-profit organization is implementing a new industry standard system called BioArch to track and process its blood products. The new infrastructure will improve the quality of its blood products since employees will be able utilize products based on inventory and age. The system also improves the product tracking process currently in place and it promises to improve customer relations since most competitors are already using the BioArch system. Currently, systems regionally are different and therefore inventory is kept separate. This creates challenges in meeting customer demands and it increases manufacturing manual processes.
The drug manufacturing industry is concerned with the development, production and marketing of drugs which are to be used as medication. This is one of the oldest industries in the world. The first drug stores date back to the middle Ages. Some of today’s pharmaceutical companies have been founded in the beginning of the previous century. Important discoveries have been made in the early 20th century such as insulin and penicillin who became mass produced. More drugs were developed during the 1950s-1960s such as contraceptives and heart drugs. During that time numerous organizations and declarations were established in order to regulate the industry. Until the 1970s the drug manufacturing industry remained relatively small, and then it began expanding quickly. With the development of technologies and the internet research, manufacturing, marketing and sales of drugs became a lot easier.
...ll help the company in selling generic drugs and provide affordable medications to its customer base.
Accuracy: All Purchases are authorized at the appropriate level. All invoices prices and quantities are compared with purchase orders and receiving reports. Journal entries are review at the appropriate level. All the Financial statements are review and approved by the senior level.
Technologically speaking every country seeks to be at the top of the list for advancement. The electronic medical record (EMR) is also an upcoming technology that allows physicians to) practice more powerful quality improve programs with paper-based records (Miller, & Sim, 2009). Adopting EMR’s is not a low cost venture, or an easy task. According to Miller, and Sim, (2009), “Quality improvement depends heavily on a phys...
Scherer, A. (2012) ‘M&A in Big Pharma: Holy Grail or Buying Time’, Contract Pharma, 21 Mar [Online]. Available at: http://www.contractpharma.com/contents/view_experts-opinion/2012-03-21/ma-in-big-pharma/#sthash.NnrBSo3O.dpuf (Accessed at: 15 December 2013)
10. Collis, David, and Troy Smith. "Strategy in the Twenty-First Century Pharmaceutical Industry:Merck&Co. and Pfizer Inc." Harvard Business School, 2007: 8-12.
Business’ such as Cadburys have the opportunity to use a range of different manufacturing processes when manufacturing their products, one of the methods that is “more commonly found in practice is the batch process” (Krajewski et al, 2010 p. 118-119). The batch method is the manufacturing process in which “each time it produces more than one item at a time.” (Slack et al, 2016 p. 191) This means that the batch method allows the business to produce a small amount of their product at
Presently in Pakistan many pharmaceutical firms are making several medicines with quite a few different titles on it on a large scales keeping in mind international hygienic standards. Most of the times much different type of medicines got merged with one another and it’ll consume lots of time if we separate it manually plus it also affects it sanitary.
the key impacts on how staff and teams are organized are similar. The most important questioned to address may not be how are staff currently being reorganized in the wake of new technologies, but rather how should staff best be deployed to take full advantages of the potential available. Other than that, to manage electronic records, we need records manager who had skills and information on how to handle the tools to manage those records. Before these recent years, all the records are being managed in form of paper based, so it must be difficult for the records managers who are more familiar with records in paper based to become expert in managing electronic records. They need to be train well on how to manage the electronic records to make them expert on it. It must be take long time to trained the especially if the record managers or staff are older. In addition, consider differences among generations in technology usage during their respective formative, pre-working years, the technological skills and expectation they ultimately bring to the workplace and their influence on work practices and recordkeeping, in particular as their members reach senior professional and managerial positions. Today technological issues offer fewer insurmountable barriers to implementation of sound recordkeeping solutions than do organizational and cultural factors, while technological innovations plays large role in recordkeeping issues and opportunities to deal with them. Because of the lack of skill of the staff, the organization would execute and budgeting staff are accustomed to funding technology projects by trading labor as human for capital as the technology investments, when in fact the necessity to maintain some records in paper form requ...
In this day and age where technology seems to be moving faster than the human mind at times, there is a constant need to keep up with the ever-changing technology innovations and just technology in general. We live in a world where we rely on technology to do a lot of things that makes our lives so much easier to get through. Over the past 20 years digital records have been an invaluable tool for doing research and managing massive amounts of data. Banks and airline companies have managed to completely go electronic and now healthcare institutions are moving in the same direction with Electronic Health record (EHR) systems. In healthcare, EHR systems have transformed a predominantly paper-based industry to one that utilizes technology on many
So it’s important to research the product and the vendor to make certain that you select the right system for your business. You’ve got to have a system that fully integrates all aspects of running your manufacturing business, offers advanced features and options but is intuitive and easy to use so employees can grasp hold quickly, and adapts to the way you do business rather than forcing you to adapt to the software.
The chapter we will be looking at today will be discussing electronic and image records. We will focus are time on key terms and key idea throughout of the chapter. The first part of this paper we are going to be look at electronic media; the second part will be record security and safety; and the final part will be image media. Electronic media will be addressing the key ideas; such as relationship between “electronic and image records; magnetic and optical media; removable data storage devices; data input; storage and retrieval procedures.”(342-348) The second part we will look at records safety and security. This section will discuss “record safety, protective measures, conversion and backup; protection against computer viruses; record security; policies and checks; security measures; data protection; security for faxed documents; and e-mail retention policies.”(350-360) The last set of ideas will confront image media.
The system should records all information of raw material, including the name, purchase date, opened date and expire date, to lower the turn over rate and the unnecessary waste of raw material.
Plex talks about how much easier this can be done with a cloud ERP System. Instead of having paperwork that must be filtered through, an employee can easily access information in the system. With the system, there is a trail in the production process that can ensure these quality checks are being completed. Industry recalls can be handled easier with a cloud ERP system. Since, all processes and quality checks are documented in the system, if there was a quality issue the business could know about it before the recall. The ERP system also helps with the auditing process that does follow an industry recall. Information is easily obtainable for these audits. Lastly, the ERP system would help with keeping up with compliance documentation. When auditors or customers need compliance documentation for a certain product, the could ERP system would have it stored in its database. This makes it easily accessible for the business owner to pull the information from anywhere that they are, instead of having to dig through paper documents filed