CIOTechOutlook >> Magazine >> June - 2016 issue

AMPLELOGIC: An Integrated Approach to Quality and Compliance Management


As global pharmaceutical and life sciences industry constantly pushes the boundaries of innovation to develop new products, the Indian pharmaceuticals market also witnessed an increase at a CAGR of 17.46 per cent in 2015 from USD 6 billion in 2005 and is expected to expand at a CAGR of 15.92 percent to USD 55 billion by 2020. However, in this era of enhanced consumer awareness, increased competition and strict FDA initiatives, it is critical that companies focus on product quality throughout the product lifecycle to reduce operational and reputational impacts. But given the stringent regulatory environment, life sciences are regularly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. The Veeva 2015 European Life Sciences Industry Survey on Customer Data also reveals that 86 percent of businesses regard improving the quality of customer data as a major challenge and all companies (100 percent) accept lacking actionable business intelligence and are looking out for solutions to deliver personalized interactions.

With regulatory requirements such as FDA GXPs, reporting mandates, international quality and safety standards and other compliance issues evolving from isolated departmental initiatives to an enterprise level challenge; leading Life Sciences companies are taking an integrated approach to quality and compliance management. Resolute to fulfill the quest of Life Sciences is AmpleLogic, headquartered in Hyderabad, Telangana, with offices in Singapore and USA that furnishes a pre-configured Smart Quality Management System to provide assurance and control on quality consistently; along with powerful automation and intelligent tracking.

An ISO 9001-2000 certified organization, AmpleLogic is a believer of Innovation and R&D that leverages its Microsoft Partnership to engage strong business relationships with the leading Pharma companies like Dr. Reddy’s, Hetero, Natco, Bharat Biotech and Granules India. Besides, on Global front, the firm serves a huge clientele from Retail, BPO, Insurance& Finance, IT& BPO and Manufacturing sectors; and makes strong impact with semiconductor companies like ASE and ISE for their MES and Enterprise Automation Needs. “We serve clients with client-focused, technology driven solutions which mark the right balance of Quality, Reliability, Delivery and Pricing.” states Venkanna Chowdary Manne, Managing Director, AmpleLogic.

Assured Data Integrity Compliance for Pharmas
Data integrity is a mandatory aspect of the regulated healthcare industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported. Being a pharma focused automation solution provider, AmpleLogic addresses the data integrity issues by mitigating the risk of data manipulation with solutions for Pharma Business Process Automation. The solutions enable workflow based print control option with Active Directory integration that prevents printing or recording of critical information on personal computers. Besides, the biometric based authentication eradicating the cases of information breaches.

Further, in its attempt to enact data integrity, AmpleLogic builds 14 ready to use apps that exclusively support QMS Automation, Batch Record Insurance Management, QC Automation, Artwork Management, Calibration Schedules Tracking Software, Training Management and Electronic Batch Recording. In addition to it, the firm also furnishes 21 CFR part 11 compliance software to maintain the data records within their original context, for accurate, complete and intact data records. “Our compliance solution is in use at 8 FDA approved and 2 WHO approved Units across the globe.” affirms Mr. Manne

Transparency across Quality Systems
Identity theft, scams, forgeries and corporate espionage have elevated document security to a pressing issue for every organization. Pharma companies are thus leveraging technology for automating key business processes to improve operational efficiencies, lower the cost of regulatory compliance and create a transparent environment for proactively identifying and resolving quality and compliance issues. Determined to empower organizations in automating their paper-based business processes and integrating them across a single platform, AmpleLogic offers Pharma QMS software and CGMP Quality Management Solution that bring an exceptional transparency across Quality Systems and resolve quality issues down their roots.

Moreover, as CAPA management and analysis is core to the effectiveness of all other quality management systems and critical for GMP compliance or regulated environments; AmpleLogic propounds CAPA Management and Tracking Software, designed to fully integrate with other critical quality systems, such as but not limited to Audits and Deviations; and manage corrective action/ preventive action from initiation to CAPA closure. CAPA software streamlines operations of Root Cause Analysis, CAPA proposal, CAPA Approval, CAPA Implementation, CAPA Effectiveness Review and CAPA Closure by automating with best practices of the industry, providing traceability across quality systems, status tracking and overdue controls.

An Initiative for Good Manufacturing Practices
GMP compliance is as important as regulatory compliance for an organization, as it ensures that the high quality standards concerning manufacture and control are met. AmpleLogic enables achievement of good manufacturing practices (GMPs) at production facilities with Batch Record Issuance Management System (BIMS), a 21 CFR Part 11 Compliant solution with a blend of Document Management and an Issuance Management. The 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. Besides, with validated procedure built within the system, manual calculations and other manual tasks are wiped out.

Further, to assist the FDA Current Good Manufacturing Practice (CGMP) regulated companies to demonstrate the process transparency of every production step, AmpleLogic enables easy integration with quality systems like CAPA, Incident and Deviations to enrich the process performance and traceability across the manufacturing process. A valuable information technology tool for organizing, automating and controlling of BRs in an industry where Batch Manufacturing takes place, under strict compliance to regulations; AmpleLogic’s eBMR software proves to be an innovative automation solution right from systematic and structured organization of documents to fully automated on-line product documentation. But as implementing eBMR requires lot of cultural changes in the organization, AmpleLogic extends a stepwise approach for a successful eBMR implementation. “To start with, organizations can initiate the Batch record Issuance Process, and post success of which companies can conduct the batch process recoding online, followed by integrating the same with equipment to auto record the equipment’s data.” affirms Mr. Manne.

AmpleLogic discerns the challenges related to track keeping of available quantity and expiry dates with the current manual log books. The firm therefore puts forth a Standards Management software designed to enable companies to manage and track the working Standards. The software ameliorates the process of track recording by providing field level details such as name of the standard, batch number, storage conditions, date and time of standard entry, quantity of standard used for analysis and analyst name; followed by sending auto alerts once quantity goes below certain limit.

Retaining Customers via Effective Closure of Complaints
Giving sole attention to quality achievement and management, the firms often overlook the importance of customer satisfaction. Though these companies have Complaint Management systems and procedures in place, but there is a need for robust solution to be responsive to customer and regulatory authorities. To allow organizations to attain and retain customers through positive customers experience, AmpleLogic renders a Market Complaints Record, Management and Tracking Software that automates the handling of complaints from initial complaint, acknowledgement, regulatory reporting, and investigation through root cause analysis, assessments and closure with any
associated CAPA.

Yielding24 x 7 global web accessibility to intake the complaints and respond immediately, the software has a centralized repository to track complaints across multiple sites and conduct fast paced investigations with robust root cause analysis tools. The system also has automated alerts & notifications facility that certifies users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions and notified directly through follow-up e-mails that are sent automatically to the user e-mail account.

Groundwork for the Future
Pharmaceutical companies are running hard to keep pace with changes brought about by digital technologies like mobile communications, cloud, advanced analytics, and IoT and therefore to play central role in the digital revolution of healthcare, the industry is looking forward to identify the right initiatives. Foreseeing rapid digitalization of pharma companies these days; AmpleLogic envisions great scope for the industry in upcoming years and thus plans at utilizing its strengths in QMS/QC automations and proven capabilities in manufacturing process areas to empower pharma clients to embrace the opportunities. Moreover, as the stringent regulations and surprise audits are the biggest concern of organizations; AmpleLogic aims to enable compliance by making migration from traditional manual systems to automated systems quick and easier. Being a front runner in the Pharma QMS Automations, AmpleLogic outlines the roadmap to multifold company’s growth in upcoming years and become a prominent solutions provider at global level for Pharma and Life Science industries.