COMPLIANCE AND SAFETY

Part 11 Document Management. Merit Solutions has extended the capabilities of Microsoft SharePoint for document management and quality control solutions for life sciences companies. The Merit Solutions MAXLife Solution extends Microsoft Dynamics AX and Microsoft SharePoint to help address the regulatory requirements of FDA 21 CFR Part 11, as well as SOP management, clinical document management and a range of quality functions including CAPA, audits management, non-conformance and complaint management.

ePedigree Tracking. Every drug manufacturer is required to serialize drug products at the item, case, and pallet level to support the ability to generate a electronic pedigree (ePedigree) document to track, trace and authenticate the product from the time it is initially sold to a distributor all the way through the supply chain to the point of distribution. MAXLife simplifies and accelerates the ePedigree process from receiving through shipment, simplifying compliance with government regulations. Read More

CAPA Resolution / Incident Tracking. Life Sciences companies are required to detect and react to problems and to ensure that appropriate actions are taken. MAXLife's Correction Action Preventative Action (CAPA) capabilities enables you to increase control and assuredness for how your organization operates. With MAXLife, you can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This Corrective Action tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems.

Product Quality Management. Quality control lies at the heart of every Life Sciences company. Designed to automate, simplify, and enforce your specific compliance processes, MAXLIfe prevents the use of lots which are in Quarantine, Expired, or are too close to Expiry to be shipped. Test at every stage of the Supply Chain: Receipt of raw materials, in-process testing while making, on finished goods after filling, sales (pre-dispatch) and field stability testing. With MAXLife, you can facilitate a full product recall within minutes or hours, not days or weeks.

Electronic Signatures. For Life Sciences companies who require increased control over system changes, MAXLife enforces dual signature authorization and the capture of reason codes and comments on your critical business documents. You decide where you need to apply a pop-up window that requires people to enter a signature, password, reason code, and note related to the change being made. Eliminate paperwork by electronically storing changes to significant documents, and enable compliance with FDA 21 CFR Part 11 and the Sarbanes-Oxley Act.

Cost of Quality Management. The central theme of quality improvement is that larger investments in prevention drive even larger savings in quality-related failures and appraisal efforts. Yet, costs related to quality processes can represent 30% or more of the total product cost. With MAXLife, Life Sciences manufacturers can focus on quality management initiatives as a source of competitive advantages while responding to the market pressures to both reduce the cost of quality and improve finished product quality.

Lot Track and Trace Management. MAXLife supports GMP requirements including electronic quarantines, quarantine release by user and material type, printed material control/obsolete components, lot control/segregation, lot tracking, and drug and hazardous reconciliation. The solution documents standard processes, and tracks and logs operations and results to support your detailed reporting requirements. With lot tracking and traceability features, Life Sciences companies can have the control and predictability needed to detect and address exceptions early, and consistently produce the highest quality products. By tracking items from cradle to grave, your company can implement effective recall procedures with complete forward and backward traceability of any material.

Complaint Resolution / Management. MAXLife manages the receiving, qualifying, recording, tracking, analysis, assignment, and validation of customer complaints. You can track any Corrective Actions or Preventative Actions that are used to satisfy the customer. With MAXLife, you can effectively manage and resolve all complaints, so you can keep your customers happy.

Access Control. Merit Solutions has developed access control functionality to meet the strict security procedures required by internal corporate policies, as well as those mandated by governing bodies such as FDA 21 CFR Part 11. With security access control, Life Sciences companies can define and enforce security policies on password management, and provide log-in access control and access restrictions to certain functions.

Process Control. To reduce the impact of new regulations, many companies are looking for ways to easily establish new controls, continuously monitor controls, and automate workflows and notifications. This allows for less reliance on resource-intensive, expensive manual oversight and greater confidence in reporting and overall operations. MAXLife provides continuous control monitoring across policies and regulatory requirements. The application delivers unified visibility for efficient management of multiple initiatives and increased confidence in decision making.

Risk Management. MAXLife risk management can help Life Sciences organizations avoid hazards and shocks throughout the supply chain. It entails more than balancing risk and reward, and it goes beyond regulatory compliance. It’s about embedding risk management into everyday processes at all levels of the organization in order to truly drive business evolution.