National promotion of electronic signature for pharmaceutical GSP first business information, sharing of common application scenarios for contract locking in pharmaceutical companies
Recently, the National Medical Products Administration (NMPA) issued a notice on further improving the supervision and management of drug operations (No. 48 of 2024), encouraging drug companies to carry out electronic exchange and management of their first business information. Qualification documents such as first-time operating enterprises, first-time operating varieties, purchasing units, inspection reports, etc. stamped with electronic signatures or electronic seals that comply with legal requirements have the same legal effect as paper documents. The so-called '; First Camp Information Exchange; That is, when pharmaceutical companies conduct business transactions for the first time when purchasing goods, they must exchange; First Camp Information; This includes nearly 20 documents such as the business license of the enterprise legal representative, drug production license, GMP certificate, product inspection report, etc. During the exchange of initial business information, the supplier's seal must be affixed and the purchaser must verify the accuracy before proceeding with drug procurement. span data-style-apply-id="font-family-f94f6
433" style="font-family: Microsoft YaHei, STXihei, Simhei, BASE; As early as the beginning of this year, the State Administration for Market Regulation's Order No. 84- "Measures for the Supervision and Administration of the Quality of Drug Operation and Use" officially came into effect. It has been clarified that the information exchanged between drug marketing authorization holders and drug wholesale enterprises when selling drugs should be stamped with the official seal of the enterprise, and the electronic version confirmed through online verification, electronic signature and other methods has the same legal effect. At the same time, the Supervision Department of the State Administration for Market Regulation has comprehensively launched pilot projects for the electronicization of first business information in 13 provinces (cities) including Jiangxi, Guangxi, Gansu, Anhui, Liaoning, Yunnan, Shanxi, Shaanxi, Jiangsu, Tianjin, Henan, Heilongjiang and Inner Mongolia. Many drug regulatory bureaus in Shanghai, Xinjiang, Shandong, Sichuan, Hainan, Jilin, Guangdong, and other places have issued documents to support and encourage the electronicization of initial business information. Since then, with the promotion and driving force of the State Administration for Market Regulation, the State Administration for Market Regulation, and the drug regulatory bureaus of various provinces and cities, electronic printing and online exchange of first-hand information have become the trend. The contract lock electronic signature and seal control platform can be integrated with pharmaceutical companies' marketing business systems and various first business information exchange platforms, providing legal and effective electronic seals, as well as identity authentication and data storage support for the first business information exchange of pharmaceutical companies, drug distribution companies, and purchasing enterprises. Nearly 20 types of first business information required by the country can be stamped with electronic seals by simply uploading them to the business system, promoting the digitization of the entire process of first business information stamping, exchange, drug release, and ordering and purchasing. img src=" https://dl.qiyuesuo.com/image/5b26d52e8b0c498985d8b5e5d19315b0.
png" style="width: 300px; First sale information real name stamping and online encrypted transmission
1. Receive real name stamping information from drug purchasers
Identity verification and integrated transmission of information stamping to ensure compliance
In the process of receiving drug purchaser information, Contract Lock helps pharmaceutical companies connect their internal marketing systems, external marketing malls, and electronic signature platforms. Pharmaceutical companies upload the collected drug purchaser information to their business systems and use the Contract Lock
Pharmaceutical companies can send their own stamped materials online, synchronize the release of drug information, and quickly place orders to purchase drugs. In the process of sending our own materials, the company can directly borrow the contract lock interface in the internal business system to automatically complete the material stamping, synchronize the release of the first drug information in the marketing mall, and the purchaser can place an order and purchase drugs with their real name, making the entire process compliant and convenient.
Rich functions to assist in online compliance exchange of first business information
① Provide electronic signature services that comply with FDA 21 CFR Part 11 regulations
According to regulations, if domestic drugs and biopharmaceutical related products need to be sold to relevant units and personnel in the United States, they should comply with 21 CFR Part 11
[an FDA (Food and Drug Administration) regulation issued by the United States in 1997] regarding electronic signatures: the signed electronic records should include; Write the name of the signer, the effective date and time of the signature, and the meaning related to the signature (such as approval, consent, etc.) in printed form;. The contract lock platform can assist pharmaceutical companies in customizing and developing electronic signature functions in accordance with FDA 21 CFR Part 11 regulations; Signature style, FDA signature activation switch, Chinese English switching, etc; Function. On the basis of handwritten electronic signatures, present pharmaceutical companies with signature printing, signature time, signature meaning, and other content required by regulations, while also implementing signatures in both Chinese and English
Bilingual, meeting the FDA electronic signature requirements for first-time drug import and export documentation.
② Implement data and functional interaction with business systems
Contract locks can be integrated with internal marketing business systems and marketing malls of pharmaceutical companies. The stamping process of each initial business document initiated for signing automatically synchronizes the signing progress, documents, and authentication status with the business system, and can be checked at any time.
(You can view the signing progress of first business information and customer authentication progress in the business system)
③ Diversified signing scenarios, optional on demand
Contract locks can be provided according to the signing needs of pharmaceutical companies and buyers; Automatic stamping” 、 “ Manually drag and drop stamp” Waiting for multiple functional options makes signing more flexible.
img src=" https://dl.qiyuesuo.com/image/0d43840d0c804714b7253ee1931f8f5f. png" style="width: 300px; " class="fr-fic fr-dib">
④ Trusted identity authentication support, ensuring real name stamping
Contract lock can embed identity authentication function into the process of exchanging first business information stamps, helping pharmaceutical companies intelligently authenticate the true identity of drug buyers and reduce cooperation risks.
⑤ Data exchange, full process data storage, and preservation of complete evidence chain
Contract locks can also provide effective data storage support for both parties' initial business information stamping, exchange, etc. Approval, stamping, downloading, authentication results, and other data are automatically saved, generating storage reports that can provide judicial evidence at any time.
⑥ Xinchuang adaptation support meets the electronic signature needs of pharmaceutical state-owned enterprises
The contract lock has been implemented in the operating system, middleware CPU、 The full stack adaptation of software and hardware, such as databases and converters, can provide electronic signature transformation for state-owned pharmaceutical organizations at any time.
> More electronic signature venues in the pharmaceutical industryScenery
· Drug testing report[Click to view details];
The contract lock can be integrated with the LIMS inspection and testing business system within pharmaceutical companies, providing online signing and verification services for PDF electronic testing reports for drug quality inspection. The quality inspector can open the business system to submit quality inspection data, initiate quality inspection stamping, and then call the contract lock function interface through the business process to create electronic files online, sign online, automatically stamp and generate electronic detection reports, and prevent tampering throughout the process.
· Drug accompanying shipment form[Click to view details]
“ Accompanying the goods and accompanying documents; It is a proof document of drug supply, which must be jointly signed and effective by the drug manufacturer and the distributor receiving the goods.
In order to improve signing efficiency, the contract lock can be integrated with the existing customer service system within the pharmaceutical company. During the shipment and transportation of drugs, an online synchronous creation of accompanying documents can be made and internal automatic stamping can be achieved. After the distributor confirms receipt, they will automatically receive the SMS signing message, authenticate their identity in real time, and electronically sign and stamp the document. The document will be signed as soon as the goods arrive.
· Doctor Speaker Service Agreement
Pharmaceutical companies participating in various medical summits and events need to collaborate with doctors, sign speaker agreements, and organize drug usage sharing. Such agreements require a large number of signatures and high timeliness requirements.
For the convenience of promoting cooperation, Contract Lock can integrate the internal business system of pharmaceutical companies to create an electronic signing platform for doctors in various regions.Medical representatives can log in to the business system at any time and draft and initiate the contract signing process with just one click through the template. Collaborating doctors can sign contracts with their real names by opening SMS messages on their mobile phones, which is fast and secure.
· Drug admission information
Drugs sold to hospitals must be provided with an official seal of the pharmaceutical company; Admission Information; This includes company qualification certificates, medical insurance bureau approvals, inspection reports, documentation, and award qualification levels. In order to simplify the mechanical stamping work, the contract lock can be integrated with the internal OA office platform of pharmaceutical companies. Through the process of batch uploading of materials, centralized approval, and one-time stamping, it can be downloaded and used at any time.
· Drug distribution channel files[Click to view details]
Contract lock can be integrated with the internal distributor management system of pharmaceutical companies, meeting the online signing needs of internal and channel partners. Distributor cooperation agreements, agent sales authorization letters, order agreements, purchase orders, sales contracts, etc. can be initiated and signed through business processes at any time. Both parties sign online and mobile contracts, and signed documents are automatically returned for archiving, making the entire process paperless and more efficient.
· Drug supply chain document file[Click to view details];
For the procurement of medicinal herbs, equipment, instruments, and materials, contract locks can be integrated with existing SRM and warehousing software of pharmaceutical companies to provide a solution; Purchase contract, packing list, delivery note, coordination note, etc; Common supply chain documents provide electronic templates, mobile signatures, bulk procurement and other services, making it more convenient for pharmaceutical companies to sign contracts with suppliers from various regions.
· Drug storage document file[Click to view details] In order to make drug delivery, shipment, and storage more convenient, Contract Lock can be integrated with pharmaceutical companies' warehouse management software to create an electronic document signing platform for warehouse managers, consignees, drivers, and other participants. The platform allows for the filling and creation of inbound and outbound orders, delivery orders, and transfer lines, as well as mobile signatures anytime and anywhere, to accelerate drug circulation.
[Click to view]: More electronic signature application solutions for the pharmaceutical industry.
>Application of Contract Lock in Pharmaceutical Related Organizations
Note: The above are some customers of Contract Lock in the pharmaceutical related industry, ranked in no particular order.
Summary
Thanks to the policy support from multiple departments of the country, the electronic exchange of medical first business information has formed a trend nationwide, which is legal and effective
a href=“ https://ww w.qiyuesuo.com/? Source=12&keyword=gw-GSP240529 "rel=" noopener noreferer "target=" -blank ">Electronic signatureThe application will undoubtedly become an important part of the first batch of electronic data.
The electronic signature and printing control platform for contract locks can be easily integrated through open integration capabilities at any time, enabling diversified services< span data-style-apply-id="font-family-570f4bc1" style="font-family: Microsoft YaHei, STXihei, Simhei, BASE;">Electronic signature, digital identity, data storage and other functions are embedded in the business process for the exchange of first-time business information, helping to complete the key online stamping ability of first-time business information, assisting in the online approval and verification of identity, online stamping and exchange of information, real name ordering and transaction of first-time business, compliance, convenience, and full digitalization!
Quick Overview of Electronic Application Policies for First Drug Sales Data Across the Country:
· Shanghai Food and Drug Administration: Several Opinions on Promoting the Healthy Development of Shanghai's Drug Retail Industry (Revised Draft for Comments)
· Xinjiang Drug Administration: Guiding Opinions on Promoting High Quality Development of Drug Trading Enterprises in Xinjiang Uygur Autonomous Region
· Sichuan Medical Products Administration: Implementation Measures for License Management of Drug Retail Chain Enterprises in Sichuan Province (Draft for Comments)
· Hainan Drug Administration: Notice on Issuing Implementation Opinions on Stimulating Market Activities and Promoting High Quality Development of Drug Distribution Enterprises
· Jilin Medical Products Administration: Opinions on Promoting Innovative Development of Drug June 1st Enterprises (Trial)
· Shanxi Medical Products Administration: Several Measures to Fully Promote the Doubling of Market Entities and Boost the High Quality Development of the Pharmaceutical Industry
· Guangdong Medical Products Administration: Notice on Improving the Modern Drug Circulation System and Promoting the High Quality Development of the Drug Circulation Industry
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