The pharmaceutical field is one of the most heavily regulated areas of business. Strict laws are in place to ensure the safety of consumers and their information.
Pharma compliance solutions can help your business stay up to date with the vast regulations in place in the pharmaceutical industry.
Learn what pharma compliance solutions do, why they are necessary, and the best solutions available in the article. Your business can benefit greatly from staying informed and utilizing a pharma compliance solution to adhere to the many regulations.
Let’s get started.
What are Pharma Compliance Solutions?
With the many laws regulating the pharmaceutical industry, managing and establishing effective compliance programs can take time. A pharma compliance solution is software your business can use to simplify the compliance process.
Pharma compliance solutions will make it easier for your business to ensure continued corporate compliance with strict data, supply chain, and product management regulations.
The software can offer increased visibility for monitoring and quality control of your products, allowing you to allocate your attention to other parts of your business.
What do Pharma Compliance Solutions do?
Pharma compliance solutions are great options for businesses seeking an all-in-one compliance service. These solutions offer updated technology to automate and streamline your business’s compliance needs. Some specific uses of pharma compliance solutions:
Regulatory Framework Adherence
A pharma compliance solution will ensure your business complies with all regulatory frameworks that affect your business. A pharma compliance solution will handle changing regulations for you by staying up to date with regulations and laws in place.
Quality Management Systems
Pharmaceutical businesses must comply with strict product regulations to ensure quality and safety for consumers. Pharma compliance solutions can gather necessary information from suppliers for the source of materials and compliance certificates.
To ensure quality products, pharma compliance services offer a management system where your business can assess suppliers’ compliance, the safety of products in transit, clinical trials, and raw materials.
Training & Competency Management
Along with the quality of products, healthcare compliance programs must include adequate employee training. A pharma compliance solution can help your business create effective training programs.
The compliance training should inform employees of regulatory standards regarding equipment, data security, and safety protocols.
Regular Audits
To continuously monitor and evaluate your business’s compliance, a pharma compliance solution can offer regular audits. In a compliance audit, the compliance service will assess your business’s compliance program to identify any non-compliance risks and weaknesses.
Healthcare businesses are subject to regulations such as the Health Insurance Portability and Accountability Act (HIPAA) which regulates how businesses handle consumers’ health information. A pharma compliance solution will offer HIPAA and other regulatory audits to evaluate a business’s data security practices.
Corrective & Preventative Action
After completing an audit or initial evaluation of your business’s compliance program, pharma compliance solutions will identify non-compliance risk areas.
Upon identifying these risks, the solutions can provide preventative and corrective actions for your business to adjust to better meet regulations.
Pharma compliance solutions can offer your business corrective measures for products, suppliers, and consumer response programs.
Why Does Your Business Need Pharma Compliance Solutions
Seeking the help of a healthcare compliance solution will help your business navigate the heavily regulated environment of the healthcare industry.
Your business can allocate time and resources to other areas, knowing your compliance is assured. Pharma compliance solutions create a net of security by providing:
Risk Mitigation
Pharma compliance solutions can help mitigate the risk of mishandling data, unsafe practices, and counterfeit products. By identifying risk areas in your business’s programs and practices, pharma compliance solutions can provide and initiate preventative actions.
Consumer Safety
Pharma compliance solutions provide technology to track and monitor production from start to finish to ensure the safety and quality of your products.
Your business can utilize pharma compliance software to upgrade supply chain visibility. By doing so, your business can ensure quality and patient safety. Your business can monitor the process from production and sourcing materials to labeling and tracking shipments.
Data Integrity
Another heavily regulated area of the pharmaceutical industry is consumers’ sensitive personal information. Regulations like HIPAA dictate how a business must securely collect and store all consumers’ health information.
A pharma compliance solution can provide data integrity assessments and assist in implementing information safety protocols to navigate these requirements.
Reputation & Trust
By utilizing a pharma compliance solution, your business will show its commitment to compliance with all healthcare regulations. You will gain consumers’ trust by using the software to increase supply chain visibility and implement dedicated data security protocols.
You can gain a competitive advantage over other businesses that do not have as much emphasis on compliance. You will have a reputation for safety and security by adhering to all pharmaceutical regulations.
Best Pharma Compliance Solutions
Pharma compliance solutions will simplify your business’s compliance program and ensure all aspects remain compliant with industry regulations. Researching and finding the best compliance solution for your business is crucial.
The best pharma compliance solution will offer the best coverage, adaptations, training, and risk assessment. We have compiled a list of some of the best solutions available that go above and beyond in ensuring your business’s compliance needs are met.
1. Captain Compliance
Captain compliance is the first choice for a compliance service for any business in the healthcare industry.
With extensive features such as risk assessment, HIPAA audits, training program materials, and HITRUST certification assistance, our service covers all aspects of compliance for your business in one simple solution.
Captain Compliance features a user-friendly interface and a team of experienced compliance professionals to help confidently upgrade your business’s compliance program.
2. First Pharma Consultants
First Pharma Consultants is a consulting business for the pharmaceutical industry. They offer a comprehensive and affordable set of compliance solutions to meet the regulations set in place by the governing bodies of the pharmaceutical industry.
3. Compliance Insight
Compliance Insight is an international compliance solution company. Its focus is to provide customized and uniquely-tailored solutions that fit your business’s specific compliance needs.
4. Intagras
Intagras is a pharmaceutical compliance software solution backed by experienced professionals and prioritizes the success of its software and client compliance.
5. Cutting Edge Information
Cutting Edge Information utilizes data analytics from a global database to inform businesses about potential non-compliance risks. Your business can be better informed of these risks and take appropriate preventative measures.
What to Look for in a Pharma Compliance Solution?
Deciding what pharma compliance solution is right for your business is an important decision. Your business’s compliance is essential, so you want to know what qualities to look for when choosing the right compliance solution.
Use these qualifications and aspects of pharma compliance solutions to compare and evaluate what each can bring to your business:
Regulatory Coverage
The most important part of any compliance solution is the complete and utmost coverage of all pharmaceutical industry regulations. Ensuring your business stays up to date and adheres to all regulations should be the top priority for any solution.
Experienced professionals and licensed specialists will know the ins and outs of pharma compliance requirements and will be able to integrate them into your business effectively.
Customization
No two businesses are the same; yours will have specific needs and requirements. An ideal compliance solution will be able to adapt to your business’s needs to provide you with the systems and information you need.
At small and large scales, for any department, you want your pharma compliance solution to assist in creating the necessary policies or relay information and reports effectively.
Data Security
To ensure compliance with regulations such as HIPAA and HITRUST, you want to look for a compliance solution that offers the most comprehensive data security software and protocols. Data security is important not only for consumers’ information but also for your business’s information.
The best pharma compliance solutions will offer firewalls, encryption, and regular access updates in their security.
Employee Training
To successfully implement new or improved compliance programs, good pharma compliance solutions will assist in creating training protocols for your business. Employees at every level must be trained effectively in compliance procedures to reduce risk and create a business-wide standard for compliance.
Comprehensive & Regular Audits
Pharma compliance solutions should always offer audits to evaluate and provide suggestions for your business’s compliance program. Regular audits are a great way to identify weaknesses in your program and provide solutions to mitigate any risks.
Continuous, regular audits are necessary for any business in the heavily regulated pharmaceutical industry.
FAQs
What is compliance in the pharma industry?
Compliance in the pharmaceutical industry means a business follows all guidelines set in place by government bodies. Businesses are responsible for complying with distribution, manufacturing, clinical trials, and consumer information security regulations.
What are compliance tools?
Compliance tools are software businesses can utilize to simplify or automate the creation and maintenance of their compliance program under industry regulations.
What are the regulatory challenges of the pharma industry?
The pharma industry’s regulatory challenges are ensuring compliance in every aspect of a business’s operations under heavy regulation. A business must comply with distribution, testing, processing, trial, and data regulations.
Who regulates the pharma industry in the U.S.?
The Foods & Drug Administration (FDA) is the government agency responsible for approving pharmaceutical drugs sold in the U.S. Among this agency are several other agencies that play a smaller role in regulations.
What are regulatory approvals in the pharma industry?
Regulatory approval in the pharma industry describes the process of testing and reporting the effects of drugs to evaluate their effectiveness and safety before being released into the market.
Closing
With countless regulations in place in the pharmaceutical industry, a pharma compliance solution can make all the difference in your business’s compliance practices.
Captain Compliance is an all-in-one solution that can ensure your business’s compliance with pharma regulations at every step of the way.
By automating and allocating your business’s compliance to professional software and compliance experts, you won’t have any doubt of your complete, continued compliance. Get in touch today!