Element

How Makromed/InfoAudit Addresses It

A. Vendor Qualification

Quality Commitment & Reputation

• Makromed adheres to the quality standards of ISO 9001 & ISO 13485.
• Makromed has been providing software solutions for quality and regulatory compliance to the healthcare industry since 1990.

Quality Performance

• Makromed welcomes its customers to audit our operations.
• We maintain a formal Software Development Life Cycle (SDLC) system.
• All software documents, including software validation plan and report, are open for audits.

B. Basic Features

Up-to-date with Underlying Regulations

• InfoAudit has ready-to-use audit checklists for several quality and regulatory standards: FDA’s GMP, QSR, GTP, and Part 11 regulations; ISO 9000 and ISO 13485 standards; EU’s MDD regulation; and FDA’s Software Validation guidance.
• InfoAudit allows unlimited user-maintainable audit checklists.
• InfoAudit provides for a central master schedule of all audits.
• InfoAudit tracks and alerts for upcoming and overdue audits.
• InfoAudit integrates the audit findings with the corresponding corrective actions.
• InfoAudit generates valuable audit and management feedback reports.
• InfoAudit has the audit template for AATB/Star Tissue Banking standard.
• InfoAudit has enhanced security and audit trail features that comply with the electronic signature and records requirements of the 21 CFR Part 11 regulation.

Auditing from Beginning to End

Click here to see the Workflow diagram of InfoAudit

• InfoAudit organizes auditing process in a series of phases:

• Set-up audit checklists and questions.
• Set-up audit master schedule.
• Plan, schedule and scope a specific audit.
• Notify the auditee and request documents for pre-audit review.
• Hold the opening meeting.
• Conduct the audit and gather objective evidence.
• Hold the closing meeting.
• Prepare and discuss the non-conformance report with the auditee.
• Undertake and implement the necessary corrective actions.
• Schedule a follow-up audit, if needed.
• Close out the audit.

Audit Management

• InfoAudit allows you to schedule audits and track the upcoming and overdue audits.
• InfoAudit presents the history of audit findings at a specific site or vendor.
• InfoAudit tracks the current status of all audits initiated.

Reports and Trends

• InfoAudit has built-in audit templates and audit finding reports.
• InfoAudit has several built-in management reports on audit status and history.
• InfoAudit has a built-in performance statistic report.

Corrective Actions

• InfoAudit has a central corrective action module that can be used for all corrective actions, including the ones associated with audits.

C. Support Features

System Configuration

• InfoAudit’s configuration module provides the following features:

• User control of audit numbering format and protocol.
• User control of business rules to enforce in the auditing process.

Access Security

• InfoAudit provides an elaborate security system to control user access of security data

• Administrators with full access
• Users with full edit rights
• Users with partial rights (ex: auditees can not edit audit plan)
• ReadOnly users
• Password rules, encrypted passwords

Audit Trail

• InfoAudit maintains a full audit trail of critical data editing activities, using the user name and date/time stamp and showing the details of what was created/added/modified/deleted.

Data Archiving

• InfoAudit provides a full built-in data archiving and retrieval system.

D. System Validation

Validation by Makromed

Click here to see the SDLC flowchart

• Validation performed in accordance with Makromed’s SDLC (Software Development Life Cycle).
• Certificate of Validation is included with the system.
• All validation documents are maintained at Makromed and are open for audits.

On-site Validation

• Work templates for Installation Qualification (IQ) and Operation Qualification (OQ) are included with the system.
• Makromed performs on-site IQ as part of the installation service, and offers on-site OQ.

E. Customer Support & Training

System Customization

• InfoAudit is the only system that includes free customization to your specification.
• All customized features are validated using the same process as on standard system.
• Customized features are carried forward to future upgrades at no additional cost.

Technical Support

• On-site installation on any computing environment is provided.
• Data migration from any existing source is provided.
• 12-months of technical support and warranty is included in the base system.
• Annual maintenance contract for extended support is available.

Training Seminars

• 2-day on-site training seminar for end users and administrators.
• Certificate of Training provided to all attendees.

F. Technical Issues

System Requirements

• Windows 95/98/NT4.0 or higher or 2000 or XP Professional; Pentium 200MHz or higher CPU; 64MB or higher RAM for Win95/98, 128MB or higher RAM for WinNT/2000, 256MB or higher RAM for WinXP; 150MB disk space.

Configurations

• Single-user, network, client/server, and web-enabled (Terminal Services)

Compatible Network Systems

• Novell, Microsoft NT, Microsoft 2000/2003

Database

• InfoAudit supports many popular backend databases such as Oracle, Microsoft SQL Server, Informix, and Paradox

Internet/Intranet

• Data and reports can be easily shared by remote sites via e-mail or publishing in PDF formats on internet/intranet.
• InfoAudit supports all MAPI compliant e-mail systems.