Maintaining compliance is critical in the highly regulated life sciences industry. At Harvard Maintenance, we understand the importance of ensuring your facility is always prepared for the unannounced visits that regulatory agencies like the FDA conduct. Failing to pass a surprise inspection can have severe consequences, including operational shutdowns that disrupt production and supply chain, resulting in significant financial losses. Our mission is simple: to help you stay audit-ready, safeguarding your operations and ensuring uninterrupted productivity.

Three researchers in lab coats walking in a modern laboratory space with indoor plants.

Leveraging Technology for Mock Audits

Being prepared for an FDA surprise inspection demands a proactive and systematic approach. Harvard Maintenance has developed an innovative solution using our proprietary HarvardSmart Technology. This cutting-edge tool enables us to conduct mock audits, simulating FDA inspections to identify potential gaps and ensure our teams and your facility are well-prepared.

The Pre-Audit/Inspection Checklist

At the core of our preparation strategy is our Pre-Audit/Inspection Checklist. Designed to ensure compliance across all aspects of facility maintenance, this checklist is integrated with HarvardSmart Technology, allowing tasks to be assigned, tracked, and completed efficiently. The checklist includes:

  1. Customer Training/SOPs: All Harvard staff members are trained and current on customer-specific Standard Operating Procedures (SOPs).
  2. Custodial Closets: Ensure all chemicals are approved for site usage and include the required documentation.
  3. Personal Protective Equipment (PPE): PPE is always readily available and appropriately used for all job tasks.
  4. Safety Data Sheets (SDS): Maintain up-to-date SDS sheets for all chemicals used on site, which are accessible for review.
  5. Notification Protocols: During shift meetings, notify staff of regulatory visits, including reasons and expected focus areas.
  6. Logbooks: Ensure logbooks adhere to Good Documentation Practices (GDP) and are complete and compliant.
  7. Collaboration: Work closely with clients to participate in pre-inspection meetings and planning.
  8. Audit Route Awareness: Prepare teams by identifying likely inspection routes and ensuring these areas meet or exceed expectations.
  9. Professional Conduct & Appearance: Staff exhibit professionalism in demeanor and appearance during inspections.
  10. Self-Inspections: Review past audits to identify areas for improvement and address them proactively.

Training: The Foundation of Compliance

A crucial element of maintaining compliance is ensuring that all team members are trained and equipped with the knowledge to adhere to regulations. At Harvard Maintenance, we prioritize continuous education for our staff, ensuring everyone is aligned with the latest requirements and best practices.

Our Commitment to Remaining Audit-Ready

Harvard Maintenance ensures that your critical environment is prepared for anything through our comprehensive approach—combining advanced technology, a thorough pre-audit process, and ongoing training. Our goal is to provide peace of mind, knowing that your facility will confidently meet regulatory standards even in the face of an unannounced inspection.

Harvard Maintenance is your partner in compliance, helping you maintain excellence and audit readiness every day. Contact us to learn more!