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In pharmaceutical and life sciences companies, many of the starting/intermediate materials consumed in manufacturing are procured from different vendors. Even some of the services like calibration and qualifications are also taken from third parties as vendor. Quality of the finished product directly or indirectly depends upon the quality of these procured materials and supporting services taken from the vendors. So, it is very necessary to ensure that the quality of material / service provided by vendor is up to the mark and serve the requirement. Hence, vendors are qualified before usage of their material in commercial manufacturing and to make this easy, electronic vendor qualification management is used by a lot of organisations
Vendor qualification is a quality management system, which assures that materials procured are produced, packaged, and shipped under a controlled process that results in consistent quality conformance and meets regulatory expectations.
VQM is required to determine vendor’s suitability for scope of work. It establishes joint agreement on specification and performance standards for subjected material(s). Vendor qualification is a requirement of regulatory bodies like US-FDA, EU-GMP, MHRA, etc.
It is very complex to manage a large number of vendors and their huge amount of data including their certificates, qualification documents, audit reports, etc. So, to simplify the vendor qualification activity and handle this data smartly we have digitalized this process and crafted a web-based application called vendor management system.
The first and foremost step of qualification in vendor management is onboarding a new vendor. During onboarding, vendor information is required and various documents like certificates, specifications are verified to start with. Along with these certificates, some questionaries are shared with the vendor to gather vendor information. These questionaries need to be answered by the vendor and submitted to the purchaser. In manual process the documents are exchanged on emails and prints are stored as per filing system of the company.
In VMS we have developed a mechanism where user gets vendor’s initial information and, certificates in electronic form for his review. Vendor registration and approval is managed electronically in this system. All the information is stored in electronic format with data privacy and security. The information can be reviewed as and when required by user. Moreover, based on review, additional information can also be asked from vendor within the system.
Various types of records/data come in picture during qualification in vendor management, like certificates, specifications, sample test results, audit reports, etc. These records are auditable, hence need to be arranged and archived properly for future reference. Any of these documents can be asked during audit and shall be instantaneously presented to the auditor as per demand. Manual management of the documents becomes more difficult and complex with increase in number of vendors. It is very tedious to find out the documents from the stack and again placing them back at right place. Using paper-based system or excel spreadsheets, it becomes time-consuming and prone to errors. By use of VMS, any document can be presented to the auditor within minutes. All the records are stored at one place in electronic form and can be viewed or printed as and when required. In VMS, vendors can be categorized as per requirement and multiple materials can be managed under one vendor. It helps to minimise the duplication of data for different materials from same vendor. Collectively, this saves the time, manpower and storage space of the document.
Different tasks need to be tracked in vendor qualification activity, like vendor audits, test results, vendor response, certificate expiry, etc. Manual tracking of the task always has some loopholes and pitfalls. If any task is skipped from tracking, it can impact on the supply of material and can hamper the productivity. Hence, to overcome this problem, VMS keeps track of every task and reminds users as well as vendors automatically for upcoming tasks. This makes user free from tracking and helps to manage the activities as per priority and eliminates the overdue activities.
Vendor audit is the important part of vendor qualification activity. Vendor audit is carried out initially during vendor qualification, there after periodic audit is scheduled. This responsibility of maintaining schedule is also taken by VMS and reminders for audits and other schedules are generated.
Further, the audit observations are also managed in the system and regular automatic follow up are taken from the vendor until compliance report is obtained.
All said and done, in pharmaceutical industries, data integrity and compliance are of utmost importance. Manual system and handwritten documents will always be unreliable and has the scope of non-compliance and data integrity issues due to missing signatures, skipped documents, GDP errors, etc. Being an electronic system, it provides reliability and brings compliance to the vendor qualification activity. It offers clear, concise, and accurate documents with all the meta data stored in the system. VMS is validated as per the regulatory requirements and comes with audit trail and electronic signatures with user authentication. VMS is compliant to 21 CFR part 11, EU annex 11 and ISO 9001:2015.