DocuSign 21 CFR Part 11 White Paper

| January 2, 2017

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Paperless. It is the nirvana that Life Sciences organizations have been chasing for the past 30 years. The time is finally now. A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. All parts of the product development cycle — clinical data management, regulatory affairs, commercialization, and everywhere in between — have invested in technologies to support operational efficiencies and productivity gains. But there has always been a gap in these technologies: the inability to effectively manage the transaction within an organization and extend beyond its four walls to collaborative partners such as CROs, customers, and other suppliers.

Spotlight

Leader Healthcare

Leader Healthcare is your trusted partner for surgical and diagnostic equipment supply in the GCC, Middle East and India. Our headquarters are based in Dubai, an ever-growing commercial hub that sets the standard for the latest world-class developments in healthcare. We pride ourselves on being part of this standard; striving towards establishing ourselves as the pioneers of healthcare equipment supply and education development in the GCC region and beyond.

OTHER ARTICLES

Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM

Article | April 6, 2020

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API). These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch. The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient. Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19. This drug is manufactured by using API, however, the Potency of this API material vary from batch to batch. To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

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WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | February 11, 2020

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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The Future of Pharma Beyond Blockbusters

Article | March 17, 2020

We’ve all heard the saying “treat the patient, not the disease”, and this couldn’t be truer in today’s ever-changing pharmaceutical landscape. We are living in a time of revolution – advancements in genomics and technology are improving our ability to develop precise drugs and targeted therapies, rather than focusing on a one size fits all approach. Each individual’s genetic makeup is slightly different from everyone else’s,

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Decentralized Clinical Trials: Imperative for Pharma Sector to fight COVID19

Article | April 3, 2020

These are unprecedented times. The world is mobbed by a contagion virus, putting people’s health at risk, threatening to destabilize economies. It has already put global healthcare systems under tremendous pressures, and managed to resist efforts to contain it. Even though coronaviruses are not new, this COVID-19 strain has created panic and forced us to be locked down in our homes sans any movement for weeks, if not months. Organizations are fighting an intense battle to keep their workforce safe, minimize risk, and ensure business continuity. For the Life Sciences industry, however, the challenge is even more significant. The whole world is looking at them to come up with a vaccine and a cure. But that is easier said than done. Bringing a new drug to market is an uphill battle and requires rigorous clinical trials. This process already has regulatory challenges. With the current lockdown situation, the Pharma community is grappled with the challenge of continuing some of the critical and time-sensitive in-flight trials so that their regulatory submission, registration, and market entry are not impacted. But all may not be lost. With the right technology solution, it is possible to turn the situation around rapidly.

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Spotlight

Leader Healthcare

Leader Healthcare is your trusted partner for surgical and diagnostic equipment supply in the GCC, Middle East and India. Our headquarters are based in Dubai, an ever-growing commercial hub that sets the standard for the latest world-class developments in healthcare. We pride ourselves on being part of this standard; striving towards establishing ourselves as the pioneers of healthcare equipment supply and education development in the GCC region and beyond.

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