Drug Accountability of the Investigation Medication begins from the selection of location for its storage. Issues with drug accountability are major and the majority of warning letters from regulators are a result of this.

Labeling process prominence has increased over the years and manufacturers are trying to manage product labeling & artwork at the same time while maintaining end-to-end life cycle changes of product labeling.

Integrity of data is ensured only when initial remains valid throughout the product life cycle. If the accuracy comes under question at any point in time then data integrity would collapse.

Current situation has led the world to remain secluded and engage more into remote activities. In such situations, like most other industries, healthcare industry too has been forced to think out of the box.

Companies who did large implementations (like RIM, EDMS, Change Management, ERP, others) have all noticed their costs and timelines doubled than what is budgeted initially.

The COVID-19 pandemic has taken a toll on the entire world affecting various sectors including the pharmaceutical industry. Unlike the other industries, the pharmaceutical industry has not come to a halt because of its need in such difficult times.

FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19. In this regard FDA has implemented few guidance documents immediately without prior public comment, because this is not feasible or appropriate at this pandemic time...

There are several suggestions, recommendations from different health authorities for sponsors to handle clinical trial aspects during this very challenging time of COVID. Most of them recommended not starting any new studies for time being.

That’s 40 hours time saved per year. The more per day time saving, obviously means more time saved in addition. Use this time that you’ll save for your strategic planning, process optimizations, improvement planning, or more coffee indulging breaks or relaxing yoga time …

In the process of implementation of QMS standard ISO 13485, many companies face common struggles; however their mistakes can be avoided when you look and analyze these things more closely. The more closer you look at the QMS requirements.

With EU MDR changing the plain field of med devices to a whole a new level, other countries are following similar path of increasing demands in product safety, traceability, performance areas. Companies not organized on information management with a system.

Drug development is becoming a complex process with each passing year. Expenses and time are not at per. Even success rates are dwindling over time and hence new drug development too loses the charm. To cater to such situations, adaptive designs are implemented.

Labels of pharmaceutical products act as an “instruction manual” to the end-users hence need to be standardized. This standardization process is often met and overcome multiple obligations like compliance issues, failure to timely update labels, non-compliance risks and so on.

Content management is becoming a burden for the life science industry when it comes to labeling. The interdependency of all the phases has a negative impact on the revenue, the rate of sales, market entrance and often leading to rejection of registrations.

The Medical Device Industry is undergoing a rapid change with an increase in the volume of regulations. Regulatory change management is an amalgamation of quality, compliance and risk management.

The market scenario of drug and device labeling is evolving rapidly and is evident with the FDA’s mandate PLR, PLLR drug labeling guidance, 21 CFR PART 801 general device labeling guidance.

Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be from business needs or local demands or regulatory compliance that needs to be maintained for those countries.

IRT’s main function lies in Supplies Distribution throughout the study and acts as a Medication Assigning Tool during Randomization/Enrollment. IRT is designed in such a way that it captures only the minimum required data fields that are useful to carry out its functions.

Clinical study and technology are two such genres that are progressing at a rapid rate. The implementation of age old practices does not suffice in any of the scenarios. Clinical trials are common in pharmaceutical industries and they occupy a major part in the approval of a drug.

If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits. This concept of Kits can be generously used to distribute and assign blinded Kits, like Open-label Rescue medication, Run in Kits.

The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other UDI-type of regulations is causing more and more medical device companies to revisit their labeling processes.

The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing significance of D to S which inspired us the build this features into our system. Our D to S is build to overcome unique challenges that come with this model.

To account all the supplies of Clinical Trial is a regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and error prone. DDi has built a robust and plug and play Supplies Accountability module into its mIRT.

EU MDR is turning digitization on its head. This new regulation, which goes into effect May 26, 2020, is inducing digitization back to the forefront. EU MDR aim to enhance medical device safety and effectiveness and to realize this, the new regulation requires the use of eIFU.

If you know your risks, I’m sure you or your teams manage them well (with KRIs or thresholds or logs or trackers). Question is what are you doing about the remaining 80% of risks. Most companies leave this key part to either untrained teams or vendors (and some of vendors doesn’t know risk management except to update a risk log before audits).

Unfortunately, most sponsors and CROs use multiple applications to manage their clinical studies. Integrating multiple applications may be challenging for example reporting through multiple apps, managing data & content across systems, limited collaboration, ease of use, Compliance with standards and the list goes on.

Clinical trials are more complex than ever and a robust, reliable & cost efficient clinical supply strategy is vital more than ever before. The number and complexity of issues affecting supply chains have also grown to include costly comparative drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials

To enter into a market, biopharmaceutical companies should have information of local regulations irrespective of the type of drug. Tracking the local regulations of semi and non-regulated markets are the biggest challenges for an affiliate as there would be certain changes expected frequently in regulatory world.

Companies who did large implementations have all noticed their costs and timelines doubled than what is budgeted initially. Yet, PwC's 2017 effectiveness benchmark report found that users spend half their time focused on mundane, repetitive tasks of gathering data from various systems. This led to many of the systems reaching the point of diminishing returns.

Is your team still using Excel sheets, or other functional teams tools (such as registration trackers or ERP) to manage your global regulatory Health Authority / Notified Body compliance activities? Learn why these tools pose either compliance or business risks if you manage your regulatory activities.