What is an Adverse Event Reporting System (AERS)?
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the life sciences, healthcare, biotechnology & FDA agency post-marketing safety surveillance program for all approved drug and therapeutic biologic products. Regulatory authorities and agencies use AERS to monitor new adverse events and medication errors that might occur with these marketed products. Reporting of adverse events from the point of care is voluntary. FDA receives some adverse event and medication error reports directly from health care professionals such as physicians, pharmacists, nurses, and consumers (such as patients, family members, lawyers and others).
Organizations operating in the healthcare domain must have processes and procedures in place to meet the AERS regulations set by authorities
Why is an AERS important?
Adverse Events Reporting System is crucial for detecting, processing & reporting adverse drug & supplement-associated events. Thus, reporting via an AERS is fundamental to detecting subject safety issues and mitigate the relevant risks with planning. This is the reason healthcare and life sciences companies are required to clearly state the method by which the adverse events will be monitored & reported. This also includes stating the provisions to ensure safety, care and medical support for those experiencing unfavourable signs & symptoms during a clinical trial.
How does AERS work?
A safety database is used to manage safety reports incoming from multiple research & study centres where the clinical trials are conducted. This database or repository of all the adverse cases can be analyzed together to flag potential trends amongst the cases. The review and analysis of the safety of a given healthcare product is given by the safety committee, which is composed of a group of experts in the field.
Recording Adverse Events
To efficiently evaluate safety information pertaining to a clinical trial, the safety reports of an organization must satisfy the reporting threshold set by regulatory agencies like the FDA. In the case of a large volume of independent adverse event reports that lack context and clarity, evaluating the safety information becomes impossible.
Thus, to maintain the integrity of the safety process and protect human counterparts, the following things must be considered while recording an adverse clinical trial event;
- Severity or intensity (mild, moderate or severe)
- Study intervention relationship
- Action taking as per the study intervention
- Outcome of the adverse event
- Whether the adverse event is serious or non-serious
The above AERS compliance requirements determine the reporting procedures that must be followed.
Need adverse event reporting system planning?
PSC Biotech will assist you in creating a strategic roadmap for determining what data should be collected and what processes need to be in place to ensure compliance with regulations, including definitions and approaches to define the roles, responsibilities, processes, forms, the communication of adverse events and the follow-up activities to ensure that complete information is obtained.
Get in touch with PSC Biotech today!
Accurate record management is a crucial operation for the organizations in Biotechnology, Life sciences, Pharmaceutical and Medical Equipment domains. The document content is growing enormously and manual sorting of the records makes it tedious & prone to errors. This is where Electronic Document Management Systems comes into the picture. Organizations in the life science industry utilize cloud-based document management software to create, modify, and maintain documents to ensure accuracy, fast retrieval and audit.
What are the challenges posed by manual document management?
Manual document management has become obsolete in the life sciences industry due to multiple challenges and inefficiencies. Some of them are;
Tedious Team Collaboration
Manual preparation of the documents is a time-intensive process that requires collaborative work. If the workflow is not streamlined, errors and delays often occur. This makes the records less reliable than automated records.
Inherent Risks of Manual Document Management
The manual process of document management leaves it prone to many human errors. This might include losing a critical document, wrong filing, erroneous labelling and misinterpretation of information. This also points to poor revision and update procedures as there are no reminders for the human users to do so.
Tracking Changes is Difficult
Keeping a track of all the versions and the relevant changes in them is a big challenge for life science companies that are using manual document management systems. This sometimes poses regulatory challenges due to the unavailability of the latest version of the document. A document might be required beforehand before its revision date has arrived and that becomes a challenge!
Physical documents require dedicated and secure storage space which maintain optimum environmental parameters. Crucial records are often stored in fire-proof and waterproof cabinets that require more space. Moreover, access to the storage has to be monitored for security & integrity of the data.
How does an Electronic Document System mitigate the above challenges?
A cloud-based Electronic Records Management system is fast, reliable, secure and efficient. Following are its benefits in the life sciences industry.
Cloud Storage and Automation
An Electronic Document Management system eliminates the need for physical document processes. Automated uploads, scanning & recognition save tonnes of labour and mistakes in maintaining crucial data about the patients.
Seamless Information Retrieval
Most advanced EDM systems come with advanced search and record retrieval features. From simple string search for the document title to page controls and tags, EDMs allow access to the latest version of any given document at any time.
Version Tracking & Security
Electronic Document Management Systems keep a track of all the versions of a document with time stamps. Moreover, watermarks can be placed on the documents as per their usage. For. e.g. Confidential, For Training, Controlled Copy, Uncontrolled Copy, etc. This also makes the process of updating documents much easier.
State-of-art Electronic Document Management systems come enabled with all the regulatory mandates. For instance, PSC Biotech’s EDM software is compliant with EU Annex 11, ISO, MHRA & WHO. The teams can access features like audit trails, e-signatures and 2-level authentication for every document.
Need a Reliable EDM Software for Your Life Science Company?
For over ten years PSC Software™ has provided cloud-based document management software for life science companies around the globe. If you would like to know how we can help your company optimize record management and streamline your business, get in touch with us today!
Computer System Validation (CSV) is the validation process used in regulated industries throughout the world to verify that a computerized system performs as it is designed to and that it maintains the integrity of its data to ensure the safety and effectiveness of the product. In the United States, the Food and Drug Administration requires regulated companies to perform validation of computerized systems that operate or support the production of the regulated products, including Pharmaceuticals, Biologicals, Medical Devices, Infant Formulas, Blood and Blood Components, Human cell and tissue products, etc.
Perform CSV when implementing a new computerized system or when you make a change to a validated computerized system. CSV processes are validation processes, based on applicable regulations and guidance documents, industry best practices, and the intended use of the computerized system being validated. In this post we are going to discuss a few best practice recommendations for effective, risk-based CSV.
Computer System Validation 101
FDA defines software validation as “Confirmation by examination and provision of impartial evidence that software specifications follow user needs as well as proposed uses, and that the precise requirements implemented through software can be consistently achieved.” In the FDA regulated world, a “computer system” is not just the computer hardware and software, but the entire system, including any equipment or instruments connected to the system, as well as the actions of the users that operate the system, and the Standard Operating Procedures, manuals, and documentation.
CSV ensures that both new and existing computer systems are suitable for their intended use(s), produce correct and trustworthy results that enable regulatory compliance, meet the User Requirements Specifications, maintain required audit trails, and provide the ability to detect invalid or altered records.
The CSV process uses a variety of static and dynamic testing activities that you should conduct throughout your entire software development lifecycle, from system conception to retirement. You should plan to validate that your system will work in all the situations that you want the system to work in. Write a CSV Master Plan. Document your CSV processes. If you didn’t document your CSV, your CSV didn’t happen.
Plan your CSV activities using some or all of these elements based on your particular computerized system and its intended use(s).
System inventory and assessments determine which systems need to be validated.
System boundary documents determine where your computerized system starts and ends.
Validation plans define the purpose, scope, and plan for the validation study.
User requirement specifications explain what the system should do. For example, “I want to drive 6 people from Reno to Las Vegas (438 miles) in not more than 7 hours”.
Functional need specifications explain how the system will look and function for the user to be able to achieve the user requirements. For example, “The vehicle speed has to be at least 80 miles per hour.”
Validation Risk assessments analyze the failure scenarios in order to determine the scope of validation efforts. For example, “Speeding ticket, flat tire, etc.”
Validation Traceability Matrix references each specification to one or more specific validation tests in the Installation, Operational, and Performance Qualifications.
Network and Infrastructure qualification verifies that the infrastructure, hardware, and software supporting the application system being validated have been installed properly and are working correctly.
Installation Qualification Protocols, Test Scripts, and Final Reports demonstrate that the system has been installed correctly in the user environment. For example, “What kind of car did I buy?”
Operational Qualification Protocols, Tests Scripts, and Final Reports demonstrate that the various functions of the system do what they are intended to do in the user environment. For example, “Do the tail lights work? Do the brakes work?, Can I do at least 80 miles per hour?, etc.”
Performance Qualification Protocols, Test Scripts, and Final Reports determine that system does what it is intended to do along with qualified people following SOPs in the production environment even under the worst case. For example, “I drive me and 5 ‘people’ from Reno to Las Vegas. Did I make the trip in less than 7 hours?”
Validation Reports include reported results, deviation resolutions, and conclusions of all activities in the validation study.
System Release Documentation documents that validation activities are completed, that the system was released by the authorized quality function, and the system is available to use.
What Is Computerized System Validation (CSV)?
Computerized System Validation (CSV) is defined by the FDA as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” – General Principles of Software Validation: Final Guidance for Industry and FDA Staff.”
In layman’s terms, CSV is the line of work where regulated companies validate their software applications by executing different validation projects in order to prove their software is working properly.
Why Is Computerized System Validation Important to My Business?
There are many reasons as to why Computerized System Validation is important, especially if you work in a highly regulated industry. If your business does fall into that category, it is likely you’re familiar with the validation of methods, processes, equipment or instruments to ensure your science is of high quality. CSV is no different. CSV is integral to ensuring the quality and integrity of the data that supports the science. If the FDA or any other regulatory body inspects your company, you can guarantee they will check on this.
Common Computerized System Validation Mistakes
The whole goal of CSV is to prove that computers and software will work accurately on a consistent basis in any situation as it complies with relevant regulatory bodies.
The timeline of CSV testing activities is never ending. CSV happens throughout the whole software development lifecycle (SDLC) – from system implementation to retirement.
With that being said, this leaves ample opportunity for error. Some of the more common ones in the industry include:
- Poor Planning – We run into poor planning issues when there are insufficient resources and inaccurate timelines.
- Inadequate Requirements – Typically, we see too few, too many, too detailed, or too vague.
- Test Script Issues – This is commonly seen with execution errors, inadequate testing, poor test incident resolution, over reliance on vendor testing.
- Project Team Issues – Associated issues include poor buy-in from all stakeholders, unavailability of key personnel at key times.
- Inadequate Focus on the Project – Resources often are pulled off to their day jobs, insufficient managerial support.
- Wasting Time on Low Value Testing Activities – There are typically inadequate risks and critical assessments.