Training & Audit Support

Internal audit readiness-

CAPA implementation-

CAPA (Corrective and Preventive Action) is the most critical subsystem of a Quality Management System (QMS). It is the mechanism used to investigate, solve, and prevent the recurrence of quality issues.

Implementing CAPA is not just about fixing a mistake; it is about finding the systemic reason why the mistake happened and making sure it can never happen again.

1. Patient Safety and Product Quality

Risk Mitigation: By identifying the root cause of a deviation (like a tablet’s weight variation or a syringe’s leak), you ensure that sub-standard products never reach the patient.
Consistency: CAPA forces you to stabilize your processes, leading to higher batch-to batch consistency and reliability.

2. Regulatory Compliance and Audit Readiness

In the eyes of regulators (FDA, CDSCO, EMA), a missing or weak CAPA system is a major “red flag.”

Proof of Control: A healthy CAPA log shows auditors that your company is proactive and transparent about its mistakes.
Avoiding Penaltie s: Effective CAPA prevents “Warning Letters” or “Form 483” observations that can lead to factory shutdowns or heavy fines.
Meets International Standards: Essential for maintaining certifications like ISO 13485 (Medical Devices) and ICH Q10 (Pharmaceutical Quality System).

3. Significant Cost Savings

Many companies view CAPA as a cost, but it is actually a major money-saver in the long run:

Reduced Rework and Scrap: Fixing the problem at its source means you stop producing defective goods that have to be thrown away.
Prevention of Recalls: A single product recall can cost millions of dollars and destroy a brand’s reputation. CAPA is the “early warning system” that prevents this.
Operational Efficiency: Investigating a machine failure might reveal that a simple change in the maintenance schedule can double the machine’s lifespan.

4. Cultural and Strategic Growth

CAPA transforms the “blame culture” into a “quality culture.”

Continuous Improvement: Instead of just putting out fires, the company focuses on getting better every day (the Kaizen approach).
Data-Driven Decisions: CAPA relies on facts, trends, and statistics rather than “gut feelings” or guesswork.
Knowledge Management: Investigating a CAPA creates a “lesson learned” database that prevents new employees from repeating the mistakes of the past.

Management Review-

A Management Review is a high-level, formal evaluation of the Quality Management System (QMS) conducted by Senior Management.

It is a legal requirement under Schedule M (Drugs) and ISO 13485 / Medical Device Rules 2017 (Devices). Regulatory auditors view the Management Review as proof that the company’s leadership is actively “in control” of quality and not just leaving it to the QA department.

The Purpose

The goal is to ensure the QMS remains S.A.E.:

Suitable: Does the system still fit the company’s size and the type of products being made?
Adequate: Does it meet all the current laws (CDSCO, FDA, etc.)?
Effective: Is it actually producing safe, high-quality products, or are there constant
failures?

Post-Certification Maintenance-

Post-Certification Maintenance refers to the continuous activities required to keep your licenses and certifications (like ISO 13485 or CDSCO Manufacturing/Import licenses) valid after they have been initially granted.

Many companies mistakenly view certification as a “finish line.” In reality, the regulator views it as the “starting line” of a perpetual compliance cycle.

1. License Retention (The “Perpetual” License)

Under the Medical Device Rules (2017) in India, licenses for manufacturing (MD-5/9) or importing (MD-15) are now perpetual, provided you maintain them.

Retention Fees: You must pay a retention fee every 5 years.
Timeline: If you miss the deadline, you have a 90-day grace period (with a 2% per month late fee). If you miss that, the license is deemed cancelled.
Reporting: You must submit “No Change” declarations or report minor/major changes to the CDSCO to keep the certificate accurate.

2. Post-Market Surveillance (PMS)

This is the most critical part of maintenance. You must prove the product remains safe while being used by the public.

Vigilance Reporting: In India, this is part of the Materiovigilance Programme of India (MvPI). You must report serious adverse events (SAE) to the CDSCO within 15 days.
PMS Plan: You must have a formal plan to actively collect data (surveys, clinical follow ups, and literature reviews) on your product’s performance.
PSUR (Periodic Safety Update Reports): For high-risk devices (Class C & D), you are often required to submit these reports annually or as specified in your license conditions.

3. Maintaining the QMS (ISO 13485)

If you hold an ISO 13485 certification, post-certification maintenance involves:

Surveillance Audits: Your “Notified Body” or Certification Body will visit you every year (Year 1 and Year 2) to ensure you aren’t deviating from the standards.
Re-Certification: In Year 3, a full audit is conducted to issue a new certificate for the next cycle.
Internal Audits: You must continue your own internal audits and Management Reviews to catch gaps before the external auditors do.

4. Change Management

5. Why Maintenance Fails

The most common reasons companies lose their certification after the first year are:

“Paperwork Fatigue”: Logbooks start having gaps once the initial excitement of
certification wears off.
Unreported Changes: Moving a machine or changing a supplier without updating the
“Site Master File” or “Device Master File.”
Missing Training: New employees are hired but not trained on the specific SOPs required
for the certified process.

Our Services

Liasoning for Medical Devices

Certifications

Training

Validation activities

Product Risk Analysis and Clinical Evaluation

Setup of Clean Room

Integrated Management System

Food Safety Management System

Automobile Sector

Energy Management System

Social Accountability

Information Security Management System