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!
What is Gap Analysis?
Gap Analyses is the systematic, documented review of an organization’s current state to identify gaps or opportunities for continuous improvement in “whatever”, be it quality systems, corporate governance, process optimization, operational efficiency, internal audit, or financial reporting. Biotechnology, Life Sciences and Healthcare organizations conduct gap analyses as a part of their continuous improvement programs.
What do Gap Analyses tell us?
Gap analyses tells you what you are doing now, how it compares to the current state-of-the-art, and what you need to do to bring your practices up to the current Good Practice used in your industry. You and your team work to close these ‘gaps’ and improve your systems and efficiency.
How is Gap Analysis conducted?
Audit companies conduct gap analyses in five phases;
Phase 1 – Planning and Preparation
This is the phase where the scope of analysis, problems, goals, and tasks are planned out. A gap analysis questionnaire is formulated along with the content, format, and schedule to conduct the gap analysis.
Phase 2 – Reviewing Background Information
In this phase, we review documents, reports, and evidence.
Phase 3 – Interviews with Stakeholders
Managers, process owners, service managers, and management personnel are interviewed in this phase. The interviews are based on the questionnaire prepared in Phase-1 of the analysis planning. This is crucial to identify and establish problems, inefficiencies and a common consensus about the goals that need to be achieved post the gap analysis, and possible solutions.
Phase 4 – Review of Draft Gap Analysis
In this phase, the stakeholders, teams and other personnel can review the result of the analyses from previous phases. It is the final step whereby the stakeholders can ensure that all the gaps have been included and nothing is missing in the draft Gap Analysis.
Phase 5 – Delivery of Final Formal Report
The final formal report contains the findings within the processes, systems and patterns of operation of the organization. Here, the stakeholders can add notes in the formal report to include the recommendations for short, medium, and long-term goals to make your gaps “disappear”.
Need a gap analyses audit expert? Contact PSC Biotech for cutting-edge quality engineer gap analysis expertise.
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!
Thermal Mapping or Thermal Validation is the method of validating or qualifying equipment and storage facilities, e.g., warehouses, storage facilities, refrigerators, freezers, incubators, cryo-apparatus, autoclaves, depyrogenation ovens and tunnels, lyophilizers, photostability chambers, SIP systems, etc., that you claim will maintain a defined temperature range or profile during their intended use and operation. Thermal mapping determines if the facility or equipment will maintain the temperature range you claim under your actual conditions of use.
If you are in the pharmaceutical, biotechnology, or healthcare industries, you need to have properly maintained, calibrated, and validated equipment and facilities, not just for regulatory compliance but for reliable and profitable operations. You need to do thermal mapping of your temperature controlled equipment.
What are the tests performed during thermal mapping?
You want to do a risk assessment before you do the thermal mapping so you can identify all of the tests you need to do based on your risks. You identify the required tests for your thermal validation study based on your risk assessment.
Common tests for refrigerators, freezers, and incubators include
- Temperature Distribution Test (Empty Chamber)
- Temperature Distribution Test (Loaded Chamber)
- Pull-down Tests
- Door Open Tests
- Power Loss Tests
- Alarm Tests
- Recovery Time Tests
Common tests for Autoclaves, Dry Heat Ovens, Depyrogenation Lines, Pasteurizers, etc., include
- Temperature Distribution Test (Partial Load)
- Temperature Penetration Test (Loaded)
- Pull Down Tests
- Accumulated Lethality (Fo and FH) Tests
Other tests to consider based on your risk assessment include
- Compressor Switch Over Tests
- Compressor Failure Tests
- Fan Failure Tests
- Emergency Generator Cutover Tests
- Routine Use Tests
How is Thermal Mapping done?
Thermal mapping involves the placement of an array of pre-calibrated temperature, temperature and humidity, or temperature and other parameter data-logging sensors in pre-defined locations within the enclosed space or the equipment. You start the data-logging sensors and run the tests specified in your approved thermal validation study protocol. You want to run the thermal validation study long enough to go through the planned defrost cycles for your equipment. If you are mapping warehouses or facilities, you may want to consider mapping studies in both a hot, dry summer month and in a cold, wet winter month to show that no matter what the weather conditions your facility meets your specifications. After the thermal mapping study, the sensors are post-calibrated to assure that the sensors are still operating as you expect.
How long does thermal mapping take?
A thermal mapping study takes one to two weeks, including the time to prepare and approve the protocol, pre-calibrate the sensors, the actual testing, and the post-calibration of the sensors. Typical thermal mapping study execution times are in these ranges.
- Temperature-controlled units (run duration or 24-72 Hours)
- Warehouse/Dry Storage Facility (1 Week)
- Cold Storage (24 Hours to 1 Week)
The thermal mapping output is temperature (and other parameters) versus time report at each location. The thermal map is a temperature (and other parameter) data plot for each location over time. The final study report demonstrates that your equipment or facility can meet your specifications when you operate it as you intend to operate it.
PSC Biotech is the right thermal mapping service
If you need thermal mapping services, calibration services, and state-of-the-art wireless or wired equipment to do thermal mapping validation of your equipment and/or facility, contact PSC Biotech. Our thermal mapping experience and supply of calibrated state-of-the-art wireless and wired sensors can meet all your needs for thermal mapping.
DATA SCIENCE IN THE LIFE SCIENCE INDUSTRY
Life sciences companies have only in recent years begun the switch from information technology to data science to fully embrace the opportunities to organize and apply their data in a systematic way to a range of drug development and patient care challenges.
The opportunities to analyze and use data continues to grow. Given the accelerating rate of learning about human biology and disease processes, the life science industry has begun to actively and use data science to achieve notable progress in drug conception, research and development.
The opportunity to take decisions based on data will help the industry to advance drug development, genomic research and clinical trials, and provide tools to answers the high-value questions in this increasingly competitive and evolving life science market environment.
BENEFITS OF INCORPORATING DATA SCIENCE INTO THE LIFE SCIENCE INDUSTRY
Incorporating data science and artificial intelligence in the life science industry will give valuable information on drug conception, drug development, risk assessment, and the effectiveness of the drug in clinical trials that will help you to improve the performance of R&D, and maintain the continuous improvement of your products and services. You are already seeing the use of data science in the current pandemic to predict virus spread and help in understanding the complex, data driven decisions to control the outbreak.
PROTECTION OF DATA AND RESULTS
You need to protect your valuable data and analysis from those who want to use your data. Data Protection is of paramount importance as the value of data increases. Training your staff is a key factor for the security of your data, as is working with a technical partner who understands the market and can withstand all the potential attacks.
Whatever the coming year holds, one thing is beyond doubt: Exciting new ways to create value are there for you, if you are willing to use the data, the tools and the techniques. Let PSC help you establish your secure data science program. Call us today.