Challenges with Current Batch Issuance Process
Life science companies’ manufacturing processes ought to be assets not liabilities. Although it is surely unintentional, too many firms treat batch records like liabilities by using manual systems that are cumbersome, slow and often archaic. Specifically organizations in Pharma industry have been traditionally using paper to maintain Batch Records like Batch Manufacturing Records, Batch Packing Records, process and equipment templates etc. in order to comply with the requirements of regulatory standards.
Errors and omissions in batch operations are inevitable and requires constant recheck while executing the process, however this manual operations wastes money and slows time to market. Manual data entry from form to form creates lag time between departments and hinders general production processes.
Few of the common problems that frequently delay manual batch operations include:
- Inappropriate data entry
- Photocopy Access leads to misuse
- Difficult to maintain 24X7 IP QA Team
- Missing signatures
- Filling out incorrect forms
- Sending the wrong form to the erroneous person
- Forms left incomplete etc.
AmpleLogic introduces Batch Records Issuance Management System (BIMS) platform to emanage the Batch Records in the most efficient and effective manner.
AmpleLogic Batch Manufacturing Record Issuance Process
AmpleLogic’s automated process Batch Record Issuance Management System (BIMS) – A 21 CFR Part 11 Compliant solution with a blend of Document Management and an Issuance Management helping Pharma Organizations in achieving good manufacturing practices (GMPs) at production facilities.
AmpleLogic Pharmaceutical BIMS software – a valuable information technology tool for organizing, automating and controlling of BRs in an industry where Batch Manufacturing takes place and meticulous records are to be maintained, under strict compliance to regulations. The system provides an innovative automation solution right from systematic and structured organization of documents to fully automated on-line product documentation.
- Only player in the market with full-fledged Batch Issuance Software Implemented at 7 FDA approved Plants
- 18 of the World’s Leading Pharma companies Batch #’s Pre-exists in our solution
- Separate Solutions Formulations and API’s (Chemicals) to simplify Business User’s Job
Batch Issuance Software automates batch and continuous process administration, making standard operating procedures available, where there is no need for paper printouts, logbooks, or binders. With validated procedure built within the system, manual calculations and other manual tasks are eliminated. Few of the distinctive features of BIMS are-
- Auto Batch # issuance with defined workflows
- Prints control with privileged access restrictions
- Audit Trail for document superseding or obsolescence
- Owns proprietary PDF component that allows workflow based prints
- Complete batch process is predefined with all possible negative Scenarios
- Not limited to Master Copy, also supports the issuance of raw data sheets, analytical sheets and check lists
By leveraging Batch Manufacturing and Packing Issuance software, pharmaceutical companies shall gain integrated compliant control of Batch Record process on a single platform. The solution helps to auto generate the Batch Nos. and printing them in all the Batch Manufacturing Record and Check list. While the platform not only generates the Batch numbers automatically but also tracks the applicants who requested for BMR/BPR and who has approved the issuance of document.
Key Features of Batch Record Issuance Management System
With hands-on experience in Batch Record Issuance, AmpleLogic continuous to be completely aware of Pharma specific compliance, security, internal processes, tools, and dynamics that plays a critical role in successfully leveraging the capabilities of a strategic partner.
Advantages with Batch Auto Issuance Process
- Eliminates costly paperwork errors, speeds up information distribution and collaboration, and enables strategies for improving quality and efficiency
- Reduced inventories
- Improves product release quality
- Automation at no cost of Process Change
- Realizes over 50% time savings in data capture, document preparation, and QA data review
- Makes it easier for Life Science companies to access and track batch records, model and change complex processes, and speed time-to-market.
- Customer Satisfaction with Process Transparency and Regulatory Compliance, results in more business
- Facilitates organizing and controlling the individual template of processes, equipment operating