#proofreading software for pharma

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Proofreading software for pharmacy

What is Proofreading?

Proofreading, at its core, is the art of meticulously examining content to catch errors, ensuring it's polished and error-free. It's like being the vigilant guardian of written documents, preventing embarrassing typos, and ensuring clarity.

The role of pharmaceutical artwork proofreading is pivotal in maintaining the integrity of pharmaceutical products. Whether through the meticulous eyes of a human proofreader or the efficiency of automated systems, the goal remains the same  precision that safeguards both regulatory compliance and patient well-being. As we navigate the future, the synergy of human and machine capabilities promises a new era of accuracy in pharma artwork proofreading.

1. Pre-press Proofreading: Pre-press proofreading is a crucial step in the production of printed materials in the pharmaceutical industry. It involves a thorough review of content, graphics, and layout before mass production to ensure accuracy and prevent errors.

2. FDA Guidelines: The FDA, or U.S. Food and Drug Administration, establishes guidelines and standards for the pharmaceutical industry. Companies must adhere to these guidelines to ensure the safety, efficacy, and quality of drugs and medical products throughout their development and manufacturing processes.

3. Incoming Material Inspection: Incoming material inspection is a quality control process where raw materials or components for pharmaceutical manufacturing are carefully examined upon arrival. This step ensures that materials meet specified quality standards and are suitable for use in the production process, preventing the use of substandard or contaminated materials.

4. Manufacturing Practices in Pharma: Good Manufacturing Practices (GMP) are regulations and standards that ensure consistent production and quality of pharmaceutical products. Adhering to GMP is essential for manufacturers to meet regulatory requirements and produce safe and effective drugs. GMP covers aspects such as facility cleanliness, equipment calibration, process validation, and personnel training.

What is Manual Proofreading?

In the not-so-distant past, proofreading was a manual affair. Manual proofreading involved eagle-eyed individuals poring over documents, hunting for elusive mistakes. It was a labour-intensive process, akin to searching for a needle in a haystack.

Manual proofreading has been the backbone of quality assurance in the pharmaceutical industry. However, it comes with its own set of challenges, including time-consuming processes and resource-intensive workflows.

What is Automated Proofreading?

Fast forward to today, and we have the marvel of the automatic proofreader or electronic proofreader. Imagine a digital assistant with a magnifying glass scanning documents at lightning speed. The role of automation in pharma artwork proofreading has revolutionised the game, bringing efficiency and accuracy to new heights. Automation has emerged as a game-changer in pharma artwork proofreading. 

Automatic proofreader refers to the use of technology, such as software and algorithms, to identify and correct errors in written content. This method relies on computer programmes that are designed to analyse and do global vision print inspection.

Automation introduces speed into the pharma artwork proofreading process, enabling the swift analysis of large volumes of artwork. An automated proofreading machine will ensure that every piece of artwork is evaluated with the same level of scrutiny, eliminating the variability inherent in manual processes.

ipvProofCheck is a cutting-edge solution that revolutionises the identification process through pixel-to-pixel comparison for carton, leaflet, and label analysis. The system sorts deviations using advanced algorithms that give an unmatched level of accuracy and make it clear whether a deviation is accepted, not accepted, or still needs to be handled. This system stands out as a 21CFR Part 11-compliant solution, adhering to stringent regulatory standards. 

Embedded within ipvProofCheck is an in-built algorithm designed for efficient proofreading of documents. It is capable of identifying nuanced issues such as character shifts, colour changes, and the absence or presence of characters. The system's pixel-to-pixel comparison methodology enables it to capture even minute discrepancies. 

Similarly, ipvPSA ensures quality control in labs. It is microscopic particle size analyser with a wide range of benefits. 

Stock Keeping Unit (SKU)

Stock-keeping Keeping Unit refers to a unique identifier assigned to each distinct product or variant in inventory management. In the pharmaceutical industry, SKUs are assigned to different drug formulations, strengths, and packaging configurations. Automation aids in SKU management during artwork proofreading by ensuring that the correct SKU information is accurately reflected in the artwork. This helps prevent packaging errors and ensures that the right product information is associated with the corresponding SKU. Automated systems can cross-verify SKU details, reducing the likelihood of discrepancies.

AstraZeneca

AstraZeneca is a multinational pharmaceutical company known for developing and manufacturing a wide range of pharmaceutical products, including vaccines such as those for COVID-19. In the context of AstraZeneca and pharmaceutical artwork proofreading, automation can enhance efficiency and accuracy. 

Automated proofreading tools can assist in reviewing and validating the content of packaging materials, ensuring that they align with AstraZeneca's branding guidelines, regulatory requirements, and specific product information.

Good Manufacturing Practices (GMP)

Good Manufacturing Practices are essential in the pharmaceutical industry to ensure the quality, safety, and efficacy of medicinal products. GMP guidelines provide a framework for manufacturing processes, including artwork creation and proofreading. Automation can play a crucial role in adhering to GMP standards during artwork proofreading. 

Automated systems can help in maintaining consistency, accuracy, and compliance with regulatory requirements. They can streamline the proofreading process, reducing the risk of errors and ensuring that the final artwork aligns with GMP standards.

Manual vs. Automated Proofreading

Let's pit the old against the new in a friendly face-off: manual vs. automated proofreading. While manual proofreading relies on human scrutiny and intuition, automated proofreading is all about algorithms and artificial intelligence. It's not a battle of superiority but a collaboration for perfection.

Manual Proofreading

Manual proofreading has been the stalwart guardian of written content for generations. It involves the meticulous scrutiny of documents by human eyes and intellect. The process is akin to a skilled artisan crafting a masterpiece, with each word and punctuation mark receiving personal attention.

Advantages of Manual Proofreading

1. Personalised Attention: The human touch adds a level of understanding and nuance that machines may struggle to grasp. Manual proofreaders can interpret context, ensuring that the intended meaning is preserved.

2. Contextual Awareness: Humans bring a wealth of contextual understanding to the table. This is particularly crucial in pharmaceutical artwork, where precision and clarity are paramount.

3. Emotional Intelligence: Understanding the emotion behind the words is uniquely human. Manual proofreading can discern the tone and intent, ensuring that the content resonates appropriately.

Challenges of Manual Proofreading

1. Time-Consuming: Manual proofreading is a time-intensive process. In industries like pharma, where time is often of the essence, this can be a limiting factor.

2. Prone to Human Error: Despite the best efforts, humans are fallible. Fatigue or distractions can lead to oversights, and the margin for error exists.

Automated Proofreading

Enter the era of automated proofreading, where algorithms and artificial intelligence take centre stage. Automation brings speed, efficiency, and a different kind of accuracy to the proofreading process.

Advantages of Automated Proofreading

1. Speed and Efficiency: Automation can scan through large volumes of content at a speed that humans can't match. This is a significant advantage in industries like pharma, where time is often critical.

2. Consistency: Machines are consistent in their approach. They don't get tired, ensuring that every instance of proofreading is approached with the same level of scrutiny.

3. Scalability: Automated systems can handle vast amounts of data simultaneously, making them scalable for the demands of the pharmaceutical industry.

Challenges of Automated Proofreading

1. Lack of Contextual Understanding: While algorithms excel in pattern recognition, they might struggle with the nuanced understanding of context that a human brain possesses.

2. Inability to Detect Certain Errors: Some errors, especially those related to context or subtle language nuances, may elude automated systems.

[manageartworks]

Why Proofreading Pharma Packaging Artwork is a Complex Challenge - And How to Solve It

Overview

In the world of pharma packaging and labeling, efficiency, consistency, and speed to market are critical priorities. Yet, given the highly volatile nature of the packaging market, pharma companies face several challenges in getting their designs right the first time. Frequent regulatory changes, the emergence of new packaging trends, and a highly complex supply chain make proofreading pharma packaging artwork an uphill battle. 

Understanding the Complexity of Pharma LabelProofing ‍

Pharma companies face several obstacles in streamlining submission and commercial artwork workflows and ensuring seamless coordination and efficiency throughout the entire artwork lifecycle. Let’s look at the top challenges that impact pharma artwork management: 

Frequent labeling changes: Pharma products are subject to several drug safety-related labeling changes. Companies must stay ahead of the latest requirements, update safety information in labeling, and get necessary pre-market approval. They also need to submit artwork to regulatory bodies before launch while ensuring every change suggested by the regulatory body is approved within the stipulated time to avoid penalty. Without the right proofing systems or processes in place, checking and verifying if changes adhere to necessary labeling requirements is difficult.  

Presence of multiple stakeholders: The packaging supply chain comprises various stakeholders, from designers to QA, marketing, legal, finance, regulatory, and more, each with a unique set of roles and responsibilities. With so many people involved, designing, developing, testing, validating, and proofreading different packaging components according to required specifications and requirements is tough. It demands regular communication and seamless project management between all parties and a common centralized platform where all packaging artwork can be stored, verified, and checked for accuracy and compliance.

Numerous regulations: Pharma packaging is driven by compliance. Any drug, whether in the market or in the launch process, goes through numerous changes driven by regulatory needs. Adapting to frequent changes arising from regulatory updates and constantly proofreading them to ensure accuracy and compliance is a Herculean task. In the absence of the right proofing software in place, pharma companies often face several hurdles in ensuring regulatory submissions, approving artwork, and catering to varied print & packaging specifications.

Various packaging formats: In the pharmaceutical industry, various packaging formats add an extra layer of complexity to the proofreading process. From cartons to foils, vials, sachets, ampoules, leaflets, etc., proofing and submitting correct artwork for different formats and strengths and addressing changes in a matter of a few hours is crucial to accelerate time-to-market Complex supply chain: Getting the packaging right the first time is never easy for pharma companies. Despite drugs being ready, companies are unable to bring them to the market because of the complexity of the supply chain. With 70-80% of drugs being generic, ensuring the right fonts, colors, design, image placement etc. for each drug is crucial to increase sales and drive revenue.

The Benefits of a Packaging Artwork Solution ‍

Given the criticality of getting pharma packaging right, companies must consider investing in a modern packaging artwork solution. The right solution acts as a centralized hub for managing all aspects of the artwork, from initial design and regulatory approvals to commercial deployment and eventual obsolescence. This accelerates time-to-market, ensures compliance with regulatory standards, reduces errors, and enhances collaboration across teams. Here’s how a modern packaging artwork solution helps overcome proofreading challenges: 

Seamless artwork lifecycle management: A packaging artwork solution paves the way for seamless artwork lifecycle management. Offering a single, centralized platform, it allows all internal department users like regulatory, packaging, QA, marketing, R&D, medical affairs, legal, etc., and external stakeholders like print vendors, artwork studios, LLPs, 3rd party, CMOs, and CPOs to design, review, approve, and manage pharma artwork quickly and seamlessly. ‍

Robust change management: A packaging artwork solution standardizes typical workflows across regulatory submissions, artwork approval, and print and packaging specs. Integrating seamlessly with regulatory and quality management systems, the solution automatically routes changes to respective departments for artwork design, proofing, and approval. This allows companies to adapt easily to frequent label changes and regulatory updates, accelerating time to market and ensuring compliance with regulatory standards. 

Automated audit logs: Modern artwork management solutions offer automated audit logs that make it easy for pharma companies to track and manage artwork copies. These logs give stakeholders much-needed visibility and insight into who has made the latest artwork change, why, and how. The solution allows users to monitor progress and update artwork status accordingly by assigning various statuses to the artwork throughout its lifecycle. 

AI proofing across artworks: Regardless of the type of artwork format, pharma packaging artwork solutions enable AI artwork proofing for graphics, text, barcodes, and Braille. Pharma companies can inspect and compare text, design, and compliance across artworks and networks. They can also ensure accurate measurement of lengths and areas and leverage annotation tools to markup changes on the artwork. 

Access control: Modern pharma packaging artwork systems also take security very seriously, offering robust access control measures. With built-in features that help enhance your Part 11 compliance, these systems encourage strong password policies, strict user and role-based security settings, audit trails with timestamps, electronic signatures with authentication and logging, and SSL-based communication. 

Digital asset management: Since pharma packaging artwork solutions centralize all assets in one place, they allow stakeholders to work and collaborate on the most recent versions of artwork files. Advanced digital asset management allows companies to easily handle various file formats using this solution, including PDF, image, document, audio, and video formats. They can also manage a diverse range of files connected to artwork, such as product briefs, specification documents, font files, source files, images, pack shots, promotional videos, and more – and use the solution as a central hub for all their digital asset requirements.

The FDA requires pharmaceutical packaging labels to display specific data, including how to use the medication and exact dosages, usage warnings, and a complete list of ingredients. Any error, misprint, or design inconsistency can lead to high penalties, causing companies to witness a dip in revenue and customer satisfaction. 

If you want to get your pharma packaging right the first time and simplify the proofreading process, you must adopt a robust packaging artwork solution. The right solution can help you stay ahead of the latest trends and ensure compliance with regulatory changes.

[secret-agent-mermaid]

As a pharmacy tech I had GoodRx downloaded to my phone because it loaded faster than the website and every new tech I trained was told to get it and use it whenever possible. No insurance? Find a discount card. Insurance says it’s a Tier 4 med so it’s $500 a month? Find a discount card. Insurance will pay full price but is making them get a Prior Auth and their doctor is too lazy to fill out forms even though they’re the one who got paid by a drug rep to prescribe brand name? Discount card.

The saddest days were always the ones where I couldn’t help someone. Their doctor had prescribed a brand name without trying any other options first, so their insurance needed paperwork showing why they did that. Doctor wouldn’t do the paperwork, and wouldn’t respond to us when we asked to at least have a different medication called in so the patient had something they could use. And it’s some brand that’s still new enough that no discount card brings it under $300. And they have Medicare or Medicaid or Tricare so they aren’t allowed to use the manufacturer’s coupon the doctor so kindly gave them and assured them would make it $25 without checking if the card said “with insurance” “$100 without insurance” or “not to be used be those with federal insurance.”

No one fights for patients. It was bad enough when I realized the pharmacists literally kept doctors from killing patients because they write scripts like idiots. Even as a tech I once caught a script that told them to take an injectable drug by mouth because they just pressed buttons on their software and didn’t proofread before sending it. I’ve also had issues typing something because they sent over that a child should be taking the equivalent of 6 teaspoons of a med per dose because they calculated by milligrams but prescribed by milliliters, and typed out the milligram amount in milliliters.

Once I realized that doctors (especially in the city) didn’t care how much something cost, they were getting paid to prescribe it instead of a tried and true generic, I lost all faith in it.

Moving to a smaller town honestly saved my mental health. Everyone I worked with had been worn down by years of skepticism and anger at the way things have become. At least here the doctors have less patients, so even if they have the same mindset they have more time that we can actually talk to them or a nurse instead of an answering machine that will never be listened to. The pharmacists have time and energy to help find discounts, are less stressed that they’ll be so overworked and tired that they’ll miss something and someone will die. We still have corporate breathing down our necks about numbers, but we have time to find ways to meet those without sacrificing care.

Find a pharmacy you trust. Find a doctor you like but realize they’re still not these perfect gods who are always right. They’re humans, and they’re not always on your side as a human even if they are as a patient. Realize that just because the face behind the counter is the one explaining a shitty thing to you, doesn’t mean it’s their fault. It’s probably a Pharma or insurance thing, they’re just the messenger. Be nice to them, try to understand what they’re telling you, even if you don’t, still understand that they don’t want it to be like this. They’ll be even more likely to help you if you treat them like humans.

Shared on the “spoon shortage” Facebook page

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The Evolving Landscape of Pharma Artwork Proofreading: A Harmony of Precision, Automation, and Cutting-Edge Proofreading Software for Pharmacy

In the intricate realm of pharmaceuticals, where precision is non-negotiable, the role of automation in artwork proofreading, supported by cutting-edge proofreading software tailored for pharmacy, is nothing short of phenomenal. Whether undertaken by vigilant human eyes or the efficiency of automated systems and dedicated proofreading software, proofreading stands as the stalwart guardian ensuring the accuracy of pharmaceutical labels.

Proofreading Unveiled:

At its core, proofreading is the meticulous art of examining content, a vigilant guardian preventing embarrassing typos and ensuring clarity in the visual representation of pharmaceutical information. In the digital age, the debate between manual and automated proofreading processes, augmented by specialized proofreading software for pharmacy, has gained momentum, challenging the traditional methods of the past.

Pivotal Steps in Pharma Proofreading:

Pre-press Proofreading: A crucial step in ensuring accuracy before mass production.

FDA Guidelines: Adherence to standards for safety, efficacy, and quality set by the U.S. Food and Drug Administration.

Incoming Material Inspection: Quality control for raw materials to prevent the use of substandard or contaminated materials.

Manufacturing Practices in Pharma: Good Manufacturing Practices (GMP) ensure consistent production and quality of pharmaceutical products.

Manual Proofreading - The Stalwart Guardian:

In the not-so-distant past, manual proofreading involved eagle-eyed individuals meticulously scrutinizing documents. While it has been the backbone of quality assurance, it comes with challenges of time-consuming processes and resource-intensive workflows.

Automated Proofreading - A Technological Marvel Supported by Pharmacy-Specific Software:

Today, automated proofreading tools, such as ipvProofCheck, revolutionize the identification process through pixel-to-pixel comparison. These tools, integrated with cutting-edge proofreading software specifically designed for pharmacy needs, ensure an unmatched level of accuracy, adherence to regulatory standards, and efficient proofreading of documents.

SKU Management and Automation:

In inventory management, Stock Keeping Units (SKUs) are crucial. Automation, alongside dedicated proofreading software for pharmacy, aids in SKU management during artwork proofreading, preventing packaging errors and ensuring accurate product information.

AstraZeneca's Leap into Automation with Proofreading Software for Pharmacy:

A multinational pharmaceutical company like AstraZeneca benefits from automated proofreading tools integrated with advanced proofreading software tailored for pharmacy to enhance efficiency and accuracy. These tools, equipped with intelligent algorithms, help in reviewing and validating packaging materials, ensuring alignment with branding guidelines and regulatory requirements.

GMP and Automation - A Perfect Blend with Software Integration:

Adhering to Good Manufacturing Practices (GMP) is essential in the pharmaceutical industry. Automation, coupled with sophisticated proofreading software designed for pharmacy applications, plays a crucial role in maintaining consistency, accuracy, and compliance with these standards during artwork proofreading.

Manual vs. Automated Proofreading - A Collaboration for Perfection Enhanced by Pharmacy-Specific Software:

While manual proofreading offers personalized attention and contextual awareness, automated proofreading, supported by cutting-edge proofreading software tailored for pharmacy, brings speed, consistency, and scalability. The future lies in a harmonious partnership, leveraging the strengths of both human intellect and machine efficiency, enhanced by specialized proofreading software for pharmacy.

Conclusion: A Symphony of Precision, Automation, and Pharmacy-Specific Software:

As technology advances, the landscape of pharmaceutical artwork proofreading evolves. The partnership between manual and automated proofreading, complemented by dedicated proofreading software designed for pharmacy, ensures a dynamic blend of precision and speed. In this ever-evolving landscape, accuracy and the reduction of human errors remain paramount. The future promises a harmonious symphony in the world of proofreading, refining and perfecting with each technological leap, propelled by advanced proofreading software tailored for the unique needs of pharmacy.