Written by: Shauna Clizbe, Business Development Manager
The biomanufacturing industry is currently undergoing a revolution in how it develops products. This paradigm shift is known as Industry 4.0. Industry 4.0 focuses on how to apply predictive modeling, data, analytics, artificial intelligence, and automation technology for the Digital Transformation of biomanufacturing manufacturing.
Companies are investing in improved analytics, process control, and more of the elements of Industry 4.0. Examples include using data and analytics from raw materials and bioproduction operations to improve the process with the goals of improving efficiency, lowering costs, and getting products to market faster. Quality Assurance (QA) and Quality Control (QC) are of utmost importance in the production of API’s, pharmaceuticals, and biopharmaceutical products, not just to meet Good Manufacturing Practices (cGMP) standards and regulatory requirements, but as a major tool in the Digital Transformation. Processes and controls must be effective and enforced throughout your facility and process, from clean room operations to calibration of instruments and preventative maintenance in utilities systems.
While investing in better automation and analytics, biopharma manufacturers can take advantage of modular, pre-validated, and pre-tested single-use equipment, bioreactors, and chromatography systems that include built in electronic batch record (EBR) and manufacturing execution system (MES) functionality. Integration of these complex systems with a QC and QA team can be a complex and sometimes difficult task. Quality Control and Quality Assurance play inter-related and essential roles. Creating successful QC and QA programs
within the organizations can be streamlined by following some best practices;
- Train your staff;
- Documentation is key, especially in the age of Industry 4.0;
- Perform at least an annual review of SOPs, policies, and programs;
- QA and QC must enable your efforts, not disable them;
Be independent of the rest of the organization;
Creating QC and QA programs in any regulated industry is essential for success; contact PSC Biotech
to learn about our Quality Services and Programs today
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!
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.
The life sciences industry is evolving rapidly and so are the challenges associated with it. The business strategy ahead is to be proactive, time-bound results and the staff trained to be able to communicate and execute all documentation requests rapidly and flawlessly. The life sciences regulatory outlook for companies in these times should be to incorporate technology-driven, an experienced team to support global agency requirements including scientific, manufacturing, compliance, and legal.
UPDATED REGULATORS REQUIREMENTS FROM THE LIFE SCIENCE INDUSTRY
Regulators now require life sciences compliance programs to operate at a higher level. Due to the current pandemic, new pricing and privacy provisions continue to become law as drugs are taking center stage in the political debates around health reform. The stakes have gone higher and regulators have made it clear that “paper compliance” is not enough and that companies are expected to maintain a comprehensive, real-time view of their compliance programs’ effectiveness. The Life sciences companies have to be more aware and ready as they are responsible for helping to improve the lives of millions of individuals and maintain a high standard of public trust.
HOW DOES A REGULATORY CONSULTANT HELP
Regulatory consultants are responsible for pre-market and post-market activities for global life science submissions. Roles further include developing and implementing regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents. Regulatory Affairs Consultants have aids in the timely approval of multiple global submissions.
With so many complex issues in play, Regulatory Consultant will play a vital role in strategic conversations on product development and also try to make sense of a constantly changing life sciences regulatory environment.
VALUE ADDITION OF A REGULATORY CONSULTANT
A regulatory consultant will add value to your company by sharing valuable insights, helping you develop strategies that you can easily incorporate in your business model and match the requirements with current changing times. With compliance top of mind for all involved when a new product nears launch, a new system is brought online, or a new business relationship is explored, companies can be better equipped to do more than comply with life sciences regulations. Active compliance can also be a force to support the needs of your teams, and the process and technological tools we use, to be better integrated and aligned in your company’s mission.