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A Beginner's guide to Online Proofing for Regulated Industries
by Carrie Wilson on June 12, 2024 8:30:53 AM EDT
With our busy working lives and a hectic digital world, our daily workflows are also becoming more time-consuming. Many industries today, particularly highly regulated sectors, encounter challenges when it comes to their marketing, what with cumbersome review and approval processes for documents and designs. Adding the traditional hassle of manual paper review or physical assets to this process only makes things even more complicated.
High-volume print runs, state variances, and strict legal compliance lead to a lot of plate spinning, with many projects running in parallel. Published mistakes come at a high price, with legal and financial ramifications.
With regulations and compliance to adhere to, as well as accuracy and confidentiality being particularly stringent in regulated industries such as pharmaceuticals, finance, healthcare, legal services, and others, online proofing is a go-to solution that can transform these industries’ marketing workflows.
Online proofing software are a means of reviewing and approving documents and designs during the creative process by applying feedback and any requested changes between users. Besides offering huge benefits, it has also opened doors to potential challenges, especially for professionals new to the process. However, these tools also empower you to overcome these challenges and master the process.
In this guide about proofing tools by the Aproove team, regulated industries will no longer be hindered by outdated paper-based processes. This comprehensive guide provides a thorough presentation of online proofing in regulated sectors, its immense benefits, pitfalls, and how it can be maximized through a few pragmatic tips.
Understanding Online Proofing
In the context of this guide, proofing tools refers to reviewing, editing, and approving documents or creative work on an online platform. Traditional practices include printing a physical copy for others to edit or delivering a Creative Cloud copy in an email attachment, for example. Instead, online proofing tools allow stakeholders to review documents in a centralized digital platform, add annotations, suggest and review changes, and track versions.
Benefits of Online Proofing in Regulated Industries
Enhanced Collaboration and Efficiency:
Platforms for online proofing help improve team collaboration by enabling multiple specialists from multiple locations – individuals in a regulated industry who have to review specific documents – to work in real-time and ensure faster approvals.
Improved Accuracy and Compliance:
Such standards are designed to ensure that industries are maintained in a regulated manner. Online proofing software will include version control, audit trails, and an approval workflow so that nothing can occur without being recorded and traced.
Cost Savings:
Proofing tools offer significant cost savings by eliminating the need for physical proofs and reducing reliance on email attachments. This not only saves on printing and shipping costs but also accelerates time to market through increased speed and efficiency, making it a financially sound investment.
Challenges of Online Proofing software in Regulated Industries
Data Security and Privacy:
Alongside legal issues, protecting and securing private information is one of the biggest worries in regulated industries. To meet data protection regulations (e.g., CCPA, GDPR, HIPAA, SOC 2), your proofing tool will need to have appropriate and secure data processes, such as encryption and secure access controls.
Regulatory Compliance:
It's crucial to recognize that each vertical industry has its unique set of compliance requirements. For instance, the pharmaceutical industry adheres to FDA regulations, while the financial sector must comply with SEC regulations. Your online proofing software should be flexible enough to cater to these diverse needs.
User Adoption and Training:
The transition to online proofing tools can be a significant change for teams accustomed to traditional methods. The success of this transition hinges on the team's adoption of the new system, which can only be achieved through adequate training and support. This might necessitate investing in a more user-friendly platform and comprehensive onboarding resources to ensure the team's comfort and proficiency with the new system.
Integration with Existing Systems:
A given product category is often characterized by being part of a broader regulatory landscape of software tools in a regulated industry. Depending on the specific application area, the product must easily integrate or communicate with existing processes that are managed via, for example, document management systems (DMS), enterprise resource planning (ERP) software, or customer relationship management (CRM) systems.
Best Practices for Implementing Online Proofing
Choose the Right Platform:
Find online proofing software with features and security measures to meet your industry’s needs. Featured items include real-time collaboration, version history, audit trails, and customizable workflows. Aproove offers all these features (and more!) for regulated industries.
Establish Clear Protocols:
Clearly define proofing protocols, such as who needs to approve what, at what stage, by when, by whom, and what those tasks/activities are.
Train Your Team:
Comprehensive training is key to ensuring your team is prepared and capable of using the online proofing software. This includes providing access to instructional modules on the platform, guidance on feedback provision, and advice on cybersecurity and compliance controls. By investing in this training, you can instill a sense of readiness and capability in your team.
Maintain Regular Audits:
Audit typical proof steps on a schedule to confirm adherence to industry standards; review audit trails, make sure you have all required approvals, that your security measures are current.
Monitor and Optimize:
Monitor the proofing process and get feedback from the users to improve it and its iterations. Try to update the platform periodically as regulations shift and technologies evolve.
Case Study: Online Proofing in the Pharmaceutical Industry
For example, online proofing tools might work in an industry with strict regulatory requirements, such as a pharma company. New drugs are developed through a series of research reports, regulatory submissions, marketing materials, and packaging designs, all of which must be reviewed and approved before being submitted to the FDA to secure approval.
Implementation Steps:
Platform Selection:
A pharmaceutical company will choose an online proofing software that is fit for purpose and FDA compliant. The software will also use agile data storage, versioning, and audit trails.
Protocol Establishment:
The company has meticulously established a set of strict protocols to review and approve documentation, clearly outlining the responsibilities of each stage (eg, researchers, regulatory colleagues, legal experts, and marketing teams) for proofing, providing a robust and reliable process.
Training:
Extensive training sessions are organized in which all stakeholders learn how to annotate and track changes on the proofing platform and approve the final versions.
Regular Audits:
The company performs periodic audits to ensure that the proofing process of tasks has complied with the FDA requirements: reviewing audit trails and verifying that all the required approvals, including dated and logged time by standard operators, have been made.
Monitoring and Optimization:
User feedback is collected to learn how to support those using the CDS. The platform and protocols can be updated to reflect new regulatory requirements and new technological developments.
We also have a great example of a case study from within the Insurance Industry and a client of ours who has successfully implemented Aproove within a regulated environment – which you can read here {link to AAA case study}
The benefits of using online proofing software are well-known to regulated industries. There are also constraints that industries need to consider in this digital world. Those include data security, regulatory compliance, user adoption, and process integration. Having a best-practice approach, including selecting the best platform, defining the workflow, training the organizations using the system, auditing it regularly, and optimizing it, can help regulated clients leverage proofing tool to optimize their workflows and become compliant.
The digital revolution is sweeping across all sectors, and regulated industries are no exception. The need to incorporate online proofing tools into their workflows is becoming increasingly urgent. These tools are not just a luxury but a necessity, offering a way to increase efficiency, accuracy, and most importantly, regulatory compliance.
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