Inspections and Audits: What You Need to Know

Inspections and Audits: What You Need to Know

Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management.

The Importance of First Impressions on Inspection Day

Did you know that the first impression significantly impacts the audit inspector? The Inspector uses first impressions to gauge the confidence and “state of control” of your company. Find out how to make a good impression by reading this blog. Also, learn about what to do when the Inspector visits unannounced.

 

Greeting
Teamwork for inspections and audits

Building an Inspection Team

Inspections of a pharmaceutical or medical device manufacturing company may have more than one Inspector. There is usually a team of company employees managing the requests of each Inspector. Who should be on your inspection team?

This blog outlines who should be on the team and what the team should be doing before inspection day.

Inspection Day: Who to Call 

Although the Quality Assurance Department leads the inspection day, Subject Matter Experts (SMEs) will be asked questions by the FDA inspectors. How to choose which SME to use? Read this blog to find out.

Practice Audits

The internal inspection team should be running audits to practice for surprise inspector visits. Practicing audits provides your Quality Assurance Department with information on gaps in readiness. Plus, practicing audits improves your confidence and gives the inspector assurance that you are in a state of control. Read about internal audits and how to improve your company one department at a time in this blog.

Inspection Management Software

The Inspector will request a multitude of documents. How can you keep track of the requests? On inspection day, you need to monitor who is filling the request, whether Quality Assurance has approved the document, whether the Inspector has received the record, etc. Using a combination of chat, email, excel sheets, etc., is time-consuming. The longer you take to fulfill a request, the more chaotic and not in a state of control you seem. Using an all-in-one inspection management software such as AuditUtopia® or ACE® Inspection can speed up your request fulfillment. Learn more about inspection management software in this blog.

Inspection Management Software PSC
Inspection

Fulfilling Requests on The Inspection Day

This blog covers paper requests, electronic requests, and interview requests. This series of articles was written in collaboration with a former FDA inspector. Don’t miss our top tips! Find out the best practices for fulfilling requests.

Wrapping Up the Inspection

 How you handle the end of an inspection? An audit might last several days. You may have some bad news. Read our blog on how to meet challenges and address concerns.

 

PSC Biotech® and PSC Software® provide support for inspections and audits.

PSC Biotech® experts have extensive knowledge and experience with submitting Global Regulatory Documents. We provide all highly regulated industries with pre-market and post-market activities for global life science submissions. Our teams develop and implement regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents.

PSC Software® options for inspection management include AuditUtopia® and ACE® Inspection. Read our case studies on how AuditUtopia streamlined inspection management for global pharmaceutical companies.

C&Q in Process Validation

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest.

PSC Consultant

Auditing – Quality Systems and Records

The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. PSC Biotech® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team.

Past Projects

Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment Project PSC® Biotech’s professional services group to perform comprehensive Gap Assessment on Cleaning Validation. Area: Toronto, Ontario Project Type: CQV About this Project OBJECTIVE Perform Cleaning Validation Risk Assessment   ...

Regulatory Agency Inspection Preparation & Quality Oversight

Regulatory Agency Inspection Preparation & Quality Oversight

Regulatory Agency Inspection preparation & Quality Oversight GLP lab accreditation and preparation for regulatory agency inspection Testing of Critical Software Activities Area: Canada, Saskatchewan Project Type: QA About this Project OBJECTIVE  Preparation for...

Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

CQV | Qualification of AQUATHERM SWS sterilizer On-site and off-site Pre-calibration and Post-calibration Verification of the Thermocouples or Wireless Data Loggers. Area: Greater Kansas City Area Project Type: CQV About this Project OBJECTIVE CQV – Qualification of...

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PSC Biotech Services provide fast, budget-friendly, high-level expertise.

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Cybersecurity | Keeping your data safe with eQMS

Cybersecurity | Keeping your data safe with eQMS

Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device manufacturing?

cybersecurity and eqms

Medical devices face additional governance from the FDA.

Secure login and device access faces further scrutiny from the FDA. The top concerns for medical devices are:

    • Privileged access
    • Identification of cybersecurity vulnerabilities and incidents
    • Prevention and mitigation of cybersecurity vulnerabilities
    • Product lifecycle challenges and opportunities

Pharmaceutical and medical device manufacturing continues to operate according to general cybersecurity best practices.

  1. Update software – new updates may have additional security measures to protect against new threats and ransomware approaches.
  2. Avoid opening suspicious emails – protect against phishing scams and data breaches.
  3. Keep hardware up to date – Software updates may work better on new machines.
  4. Protect against unauthorized access – use a secure file sharing system, use secure logins, be sure to log out, etc.
  5. Train employees – practice cybersecurity to minimize susceptibility and vulnerability.
  6. Simplify – tracking updates to multiple software platforms and tracking training through various training methods can be complicated. Prevent gaps in training and tracking by simplifying and performing routine gap analyses.

How to protect your electronic quality management system

Your electronic quality management system (eQMS) is your pipeline. The PSC Software® family of eQMS and inspection management software includes the Adaptive Compliance Engine (ACE®) platform and AuditUtopia®.

  1. Update software – ACE® and AuditUtopia® have three updates per year. Every update is ready-to-use, GxP compliant, validated, and qualified.
  2. Secure access – ACE® and AuditUtopia® has configurable options to manage accounts via Single Sign On, Active Directory, OKTA, 2FA (two-factor authentication). Plus, ACE® and AuditUtopia® have tiered administrative access and role-based permissions restrictions.
  3. Secure storage – ACE® and AuditUtopia® are cloud-hosted via Amazon Web Services (AWS). By utilizing cloud-based software from a specialized hosting platform, you benefit from the teams of people working on cybersecurity for data storage and data access. AWS is compliant with many ISO standards for pharmaceutical and medical device industries, such as ISO 9001, ISO 27001, ISO 27017, and ISO 27018. Find out more about AWS cybersecurity here.
  4. Train employees – ACE® provides a structure for internal training documentation and tracking. Reduce the headache of tracing, tracking, and performing gap analysis for training on cybersecurity protocols with ACE®.

PSC Software® Solutions

PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software specializing in pharmaceutical, medical device, and other regulated industries. PSC Software® is dedicated to cybersecurity and GxP compliance with the added goal to develop software that is intuitive to use, easy to learn, and flexible to fit each company’s needs.

 

Join us for a free webinar.

Contact us to find out more!

PSC Biotech® provides quality and compliance professionals for consultation on life science manufacturing. Check out PSC Biotech® for metrology, engineering, quality assurance, CQV services, and more!

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PSC Software Solutions

ACE

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PSC Biotech Services provide fast, budget-friendly, high-level expertise.

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The Pitfalls of Data Migration

The Pitfalls of Data Migration

Did you know that the FDA regulates data integrity? Pharmaceutical and Medical Device industries must operate in accordance with current Good Manufacturing Practices (cGMP) for regulatory industries, such as the FDA and MHRA, to deem a product as safe for consumers. Although the focus of cGMP is often in the material production of the product, the data generated in the testing and tracking of a product also falls under regulatory scrutiny. Some would say that the data and company records are the crux of regulatory inspections.

What is Data Integrity?

According to the FDA, “data integrity refers to the completeness, consistency, and accuracy of data”. Requirements for GMP-compliant data include:

  • Data are exact and complete, secure from alteration, accidental erasures or loss. This extends to backup data.
  • Documentation is generated at the time of performance. In other words, data cannot be initially transcribed on scrap paper then transferred into a lab notebook.
  • Laboratory controls are “scientifically sound” and complete. Complete means all the information derived from all tests. For example, a spectral report must contain the entire read-out and each complete read-out is stored.
  • Electronic signatures and record-keeping are compliant with 21 CFR part 11 regulations.
data migration

Electronic Quality Management Systems (eQMS)

Besides testing and tracking of production, your users, audit documentation, training documentation, and blank forms are regulated under GMP guidance. Since the complete data generated in pharmaceutical and medical device manufacturing is extensive, most companies rely on electronic records. It is possible to use a combination of various documentation software, tracking spreadsheets, paper documents, emails, and chat programs for data management. However, this is inefficient for auditing and often ineffective. An FDA inspector will scrutinize the time it takes to retrieve complete documentation during an audit. The general rule of thumb is to fulfill an audit request in fifteen minutes or less. Frequently, successful companies use an electronic quality management system (eQMS) to manage the data and documentation generated in pharmaceutical and medical device manufacturing.

PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software with specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries. The Adaptive Compliance Engine (ACE®) eQMS is a single platform eQMS that is highly configurable to your company’s quality and manufacturing

ACE® is absolutely the most configurable EMS platform you will find. It is the type of system that becomes your most trusted system of use and record; and which is a force multiplier for efficiency, speed of information, knowledge preservation, document management, SOP development, and countless other activities particular to your industry.”

-- Verified Reviewer on Capterra

Data Migration into an eQMS

At home or in non-regulated businesses environment, getting a new phone or computer is simple and transferring data is only a small headache. Data migration while following GMP regulations requires significantly more testing, sampling, and verifications. We will go through the process of data migration in the case of using PSC Software®.

Pitfall #1: Maintaining GMP compliance during migration.

Solution: Utilize consultants trained in data migration for GMP regulated industries.

PSC Software® provides a data migration service with trained professionals in computerized systems compliance. A data migration is a joint effort between the client and PSC Software®. PSC Software® develops the migration plan, workflow, templates, and protocol. The data comes from you.

Pitfall #2: Poor data quality.

Solution: Perform a gap analysis ahead of time. Make source data quality a priority.

Missing records, duplicates, misspellings, erroneous data, incomplete data and records may exist within a multi-platform quality management system. Perform a gap analysis before migrating your data. The old adage, “Bad Data In = Bad Data Out,” applies to data migration too. PSC Biotech® has consultants experienced in gap analysis for regulatory compliance.

If the import data is not formatted correctly, extra time and resources will need to be spent on “scrubbing” the data. In worst case scenarios, the data import itself will have to be re-executed. Spending time on data quality pre-migration is more efficient than hastily importing data.

Pitfall #3: Deficient documentation of the migration process.

Solution: Develop a migration plan, workflow, templates, and protocol ahead of time.

Avoid failing regulatory guidelines by developing a migration plan, workflow, templates, and protocol ahead of time. PSC Software® professionals provide these services when assisting with data migration. In the planning stage, you can check that data will remain complete, consistent, and accurate while maintaining records according to the ALOCA principle:

    • Attributable – the who, what, when, where, and why
    • Legible
    • Contemporaneously recorded
    • Original or a true copy
    • Accurate

Pitfall #4: Lack of communication and collaboration.

Solution: Define responsibilities, involve concerned parties, and understand the process.

The following is an example of the division of responsibilities in a successful data migration for pharmaceutical and medical device manufacturing.

PSC Software® Responsibilities

    • Authoring of migration plan and protocol
    • Record metadata matrix
    • Provide data import template(s)
    • Test import and check for data errors
    • Migrate into production
    • Sample records to verify successful import
    • Provide data migration summary report

Client Responsibilities

    • Review and approve migration plan and protocol
    • Provide pre-scrubbed data in approved import templates
    • Correct any data issues
    • Provide access to data for migration
    • Review and approve data migration summary report

PSC Software® Solutions

Using an electronic quality management system avoids many pitfalls of quality assurance and regulatory compliance. Data migration is easier with professionals. Ensure your data integrity and regulatory compliance when switching to ACE® with PSC Software® professional assistance.

 

Contact us to find out more!

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PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

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Inspections and Audits: What You Need to Know

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Get Your Cleanroom Ready for Business

Get Your Cleanroom Ready for Business

When you think of a pharmaceutical or medical device company, cleanliness comes to mind when production comes to mind. Cleanrooms are a necessity when it comes to a company’s production area. What is a cleanroom exactly? A cleanroom is a controlled environment used in manufacturing with a low level of pollutants, such as airborne microbes, dust, and aerosol particles. Pharmaceutical and medical device companies follow specific regulatory standards, primarily following the ISO 14644-1:2015 guidelines. Your company must follow different rules and regulations depending on the product being manufactured. Before production can begin, you must determine what type of cleanroom it is and then have the cleanroom qualified for use. For this example, a medical device company has a cleanroom that needs to be put into production. Let’s go through the steps you must take to get your cleanroom ready for business.

How to initiate a cleanroom

First, you need to determine what room classification the cleanroom needs. The classification is a guideline for how many particulates are acceptable for the manufactured product within the room. Once you have determined the cleanroom classification, you can assemble the appropriate documents such as standard operating procedures, room qualification, and testing forms. The SOPs address how the cleanroom will be used, qualified and cleaned. Qualification tests the room’s controlled aspects to ensure it is acting as it should. Finally, you create the forms to report the findings of cleaning and environmental monitoring.

How to test a cleanroom for qualification

Cleanroom testing differs from environmental monitoring because cleanroom testing concentrates on the room performance, not the product contamination risk. When qualifying a cleanroom, you want to test for differential pressure, airflow, temperature mapping, and particle counts in this example for medical devices. Differential pressure measures the pressure within the room and what happens when the main door is open. It will tell you how long it takes for the pressure to go out of range when the door is opened and how long it takes to come back to its range. Airflow will let you know the airflow at each HEPA filter. Particle counts determine the number of particulates in a specific spot in the room. Temperature mapping tests the temperature throughout the room during a 24-hour period. Qualifications can be done in different ways. In this example, testing was done with no one in the room, and when power was shut down in the room to see how long it took for the particle counts to fail and when power was restored. Testing was also conducted with the maximum number of people the room will have during manufacturing.

cleanroom ready

After testing is completed, all data must be reviewed and within passing specifications for the room to be qualified and ready for use. Depending on your companies’ policies, quality assurance should be the last department to review the qualification for final approval. The qualification must be checked for any deviation that may have occurred, which must be investigated and closed out to be approved.

 Get a jump start on cleanroom qualification

Your cleanroom is a vital part of your business and needs to be ready for manufacturing. You want your cleanroom to be prepared and within specification, and if you are not quite sure, let the PSC professional help you along the way. PSC Biotech® can help you in each of these steps – from helping you create documents to performing your qualification and compiling your final report.

Written by Ashley Castro, PSC Biotech® Consultant

Edited by Crystal McClain, PhD

See Also

PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

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Record Keeping and Documentation for GMP compliance

Record Keeping and Documentation for GMP compliance

 A company’s records are a prized possession and should be taken care of the best way possible. When we think of good manufacturing practices (GMP), regulations must be followed to keep the quality and integrity of your records in good standing. Current GMP regulations for pharmaceuticals regarding records and documents are listed in FDA code 21 CFR 211 subpart J: Records and Reports. Records keep track of what a company is doing and identify issues or situations that may arise. These records allow auditors to see what is being produced, how it is being tested, issues, corrective actions, and many other items.

Consumers like to see proof and facts about the products they intend to use, and that proof is in the documentation and records. Let’s dig a little further and see just how helpful the GMP guidelines can speak volumes. The quality assurance department will manage the record-keeping and the documentation of all records.

Records GMP compliance

Record-keeping and documentation guidelines for GMP are remarkably straightforward and exceedingly precise. Let’s take the example of a batch record that has just been completed by production. Here are some of the general requirements related to the example.

    • All documents must be designed, reviewed, and distributed with care. In the example, the management department created a batch record, which the quality assurance department reviewed. Batch records can only be printed by quality assurance to ensure that the record is being given to the appropriate personnel. Thus, not everyone can print a batch record. Furthermore, this process makes sure the correct document is being used.
    • All documentation must be clear and legible. Every entry into this batch record must be written clearly to maintain integrity. Your company does not want the FDA to come in for an audit and ask for a record that they can’t read or understand what is going on.
    • All documents must be approved, signed, and dated by the appropriate personnel. For this example, when the batch record was created, the document went through a workflow of reviewers and approvers until final approval. At this point, the document was approved, signed, and dated, which allowed the batch record to become live and functional.
    • Documents must be very specific in title, content, and purpose. There cannot be documents that can be misinterpreted or used in a different process. A batch record has to be specific to what is being produced. The label must have a product name, the dosage, and the procedure used—no open-ended interpretations.
    • Documents must be reviewed and updated regularly. Your company’s standard operating procedure should state how often a document should be reviewed. Also, send that document through its workflow to get updated whenever a revision should be made. There is always something that can make things run faster or better, which is why updates occur. Also, new sets of eyes can find issues with a document, so regular reviews are necessary. You would rather have an employee notice the problem than the FDA auditor.
    • Documents must always be typed and never handwritten to prevent misreading information because it is not legible. It also controls any unnecessary corrections or changes from being made.
    • Corrections to any document or records have to be crossed out with one line, initialed, and dated at the time of correction. Another important thing to add is the reason for the correction, to clarify why the correction was needed.
    • Actions in manufacturing and the control of products must be recorded clearly for traceability. Batch records are a step-by-step process that must be followed precisely as the batch record states. After each step, initials and date should be recorded.

Record-keeping and documentation are essential to a company, and shortcuts should never be made. If the GMP guidelines are managed well, there should be no issues when audited by the FDA, who enforce GMP regulations. Any major infraction can cause the company to obtain 483’s (see Inspection Observations | FDA), which a company never wants. PSC Biotech® can help your company become compliant with your documentation by offering document review (see Document Review 101) services.

PSC Biotech® Quality Engineers specialize in QA Oversight, Gap Analyses, Training Compliance and Support, Review and Approval of Validation Documents, CAPAs, Non-Conformance Reports, Quality Agreements, and the facilitation of project documentation. We have expertise in quality compliance, audit rights, regulatory inspections, regulatory documentation, staff training, change control, qualification, investigations, deviations, production, stability, and complaints for Operations, Engineering Services, and IT Services. With over 25 years of business in regulatory compliance, contact us for all your GMP needs.

Written by Ashley Castro, PSC Biotech® Consultant

Edited by Crystal McClain, PhD

See Also

PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

Quality Risk Management for Commissioning and Qualification

Quality Risk Management for Commissioning and Qualification

Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification,...

Inspections and Audits: What You Need to Know

Inspections and Audits: What You Need to Know

Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...

Cybersecurity | Keeping your data safe with eQMS

Cybersecurity | Keeping your data safe with eQMS

Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device...