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QA/QC x Pharma -The regulations we follow

21 CFR part 11 Compliance Requirements & Checklists in QA/QC for Pharma regulated industry


The pharmaceutical industry is undoubtedly the most highly regulated industry in the world being the sole drug based contributor to the healthcare system. Software testing is an essentially vital component of authenticating pharmaceutical applications due to its highly complex workflows and its subsequent human life-threatening risks. With the persistent pharmaceutical industry demanding new features and integration with other systems, good software QA/QC protocol compliance is mandatory.

Did you know?

A case study published in Pharmacy Times talked of a woman under medication for three months who was accidentally dispensed by a pharmacist. Resulting in her suffering serious health ailments till a certified board physician detected the underlying cause. For safer medication, quality checks of pharmaceutical applications and enhanced methods of drug dispensing are undoubtedly important. Testing pharmaceutical applications and Software Testing in the Pharmaceutical Industry is high regulation bound being much more complex and resource intensive than other tech based domains.

The benefits of data-driven quality management software in pharma can boost all pharma efficiency. Needs further understanding of a tester’s roles while testing pharmaceutical applications and meeting the criteria for Software Testing in the Pharmaceutical Industry.

Domain Knowledge:

Domain knowledge is key to testing a pharmaceutical application. Unlike other software systems, the pharmaceutical industry deals directly with the health and well-being of people at large undergoing specific ailments including physical and psychological trauma. Any error inputs in data or patient treatment plans in the system can potentially lead to serious and fatal health issues. Therefore, it is essential for the software test team to be familiar with all the critically requisite business scenarios.

Business Critical Applications:

All pharmacy systems are highly health-critical applications. The software systems not displaying a clinical warning for drug allergy reactions, might cause severe health repercussions for all the patients. Therefore, testers need to reconfigure all patient and drug information so that it performs all the plausible clinical checks prior to allocations.

Attention to Numbers:

Software testers must pay attention to all the numbers being used in the pharmacy system; like the dose quantity specified by the prescriber. Any errors in dosage can lead to severe health issues causing an unintentional overdose of medication causing certain possibly fatal side effects. In addition, testers should also focus on the system functionality which allows the system to auto-populate dosages via auto generated SMS, email, or phone call for patient medication.

Keyboard Shortcuts:

Most pharmacists use keyboard shortcuts for daily work expeditions. A comprehensive list of keyboard shortcuts should be prepared prior to the start of the QA testing phase and should be shared with all the stakeholders and the software test team.

Availability of Test Data:

QA Testers must be provided prior information about real-time drugs and diseases which cause interaction or contraindication between two drugs or create an allergic reaction with a patient’s lifestyle or medical history. A checklist of all test data needs to be prepared before starting the test execution. The source of test data must be fully reliable.

Defining 21 CFR Chapter 11

21 of the CFR or acronym for the Code of Federal Regulations deals specifically with governing food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency), and ONDCP (Office of National Drug Control Policy).
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.
Chapter 11 deals specifically with digital signatures and all ancillary electronic record-keeping mandates.

Industries applicable for FDA 21 CFR Part 11

21 CFR Part 11 applies to any electronic records or digitized signatures that are maintained, created, or processed under records requirements defined by the FDA. Any electronic records stored, signed, or processed digitally for life sciences, and biotechnology fall under FDA regulation. Mandatory to all businesses operating in the US, life sciences, medical instrumentation, biotechnology, pharmaceuticals, or similar industries. Including non-food businesses under FDA jurisdiction meet 21 CFR Part 11 compliance. At present, since it is difficult to store paper records, almost all businesses bookkeeping digital and electronic records are mandated within the regulation.

FDA 21 CFR Part 11 Compliance Quest

Compliance Quest (CQ) enables 21 CFR Part 11 FDA for all life science organizations such as healthcare, pharmaceutical, biotechnology, medical manufacturing, medical devices, including other FDA-regulated industries. It facilitates implementing controls on auditing, system validation, digitized electronic signatures, and e-documentation for software systems involved in processing valuable data, business practices, and product development. 21 CFR Part 11 executes the FDA’s validation of all electronic records and electronic signatures as fully trustworthy, authentic, reliable, and legally equivalent to paper records and handwritten signatures. Helping adopt a future proof ‘paperless’ system of record keeping.

FDA 21 CFR Part 11 Importance

FDA 21 CFR Part 11 is highly essential for the following reasons:

  • A detailed audit trailing requires the software deployment to be capable of maintaining daily records of all user functions.
  • Electronic signatures: Systems with 21 CFR Part 11 compliance can assign electronic signatures to each user with legally binding.
  • User identification security controls.
  • Unauthorized system access prevention, 21 CFR Part 11 compliant systems have security features mandating limited user access with privileges solely based on roles and responsibilities.

Listing all 6 major 21 CFR Part 11 requirements mandates for compliance.

Audit Trails: Audit trails require the access controls to be revalidated with the proof of operator access creating a digital system of records. An important factor in understanding 21 CFR part 11 compliant software is mapping the way electronic records are created, modified, reviewed, authorized, and controlled.
System feature time to facilitate auditing for every single digital document and record- It should mandatorily indicate the record modifier user ID, the date and time of modification, and the specific items of modifications. Ensuring the trail is easily restored and demonstrated.
The system implementation of 21 CFR part 11 digital signatures. 21 CFR part 11 compliant electronic signatures attesting to the creation, review, or approval by an authorized reviewer.

Digital Signature: 21 CFR Part 11 compliance is fully focused on bookkeeping electronic records, streamlining activities, and e-signatures. For all captured digital signatures to be fully compliant, they are computed by rules and parameters verifying the ID of the signer and the authenticity of the data provided.

Access Vigilance: With access granted to authorized users, the legitimacy of the records and signatures for audit must be mandated. Each user with an unduplicated login credential enables all activities to be easily identified, illustrating all the authorized access controls in place.

The policy works: All policies regarding operating and maintaining the hardware, and software, including physical records of the organization are clearly documented. They are fully covered during training for anyone with the policy records access.

Validation: Regular system validation checks mandated are logged to meet all compliance requirements. All FDA auditors ensure the data integrity of the system prior to reviewing.

The checklist mandate for FDA 21 CFR part 11 assessment validation include:

  • System compliance with FDA 21 CFR part 11 security requirements.
  • Authorized user authentication credentials
  • System data encryption
  • Statement of procedure (SOP) of system management.
  • Record maintenance as per the defined record retention period for each record type.

Training: 21 CFR Part 11 requires users with system access to be fully trained in protocol compliance. Employees are trained for specific roles with an awareness of the limitations of access controls and responsibilities. All training is documented so FDA auditors can review the operator audit trail by cross-referencing with the training logs.

21 CFR Part 11 Compliance Checklist

A 21 CFR part 11 compliance checklist can assess a system’s compliance with the regulation. Companies must deploy the 21 CFR Part 11 Compliance Checklist to the regulators ensuring a robust system to meet FDA criteria and standards. A comprehensive 21 CFR Part 11 compliance checklist guides all pharma businesses through the complexities of regulatory requirements assisting to meet the applicable compliance standards. The checklists also aid in the improvement of system processes and procedures establishments. Helping in identifying risk laden areas.

21 CFR Part 11 Compliance Checklist mandates the following as essential:

  • Internal Assessment of 21 CFR Part 11 applicability
  • Following all 21 CFR Part 11 data security and password protection best practices
  • Recording clear audit trails for traceability
  • Following all 21 CFR Part 11 guidelines on electronic signature mandates
  • Validation of IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification)

21 CFR Part 11 Critical Mandates

21 CFR Part 11 validates all elements of the system via developing test scripts and deploying testing routines to authenticate its functioning. EQMS validation promises data security and audit logs with higher integrity of digital record keeping.

Record Keeping
21 CFR Part 11 validated EQMS enables a search and indexing functionality easing accessibility. EQMS solution can save all document changes and iterations displaying the digital signatures of approvals.

Audit Trails
A good QA function in maintaining audit history ensures all processes are well documented and traceable to individual originators. This audit history must be auto generated.

Control Operations
EQMS allows for all intrinsic quality procedures to be auto-monitored ensuring documents are reviewed by specified individuals meeting certain requirements before signing off prior to the contingency phase.

Security And Access Controls
System access should be controlled by a unique login and password for all users. EQMS ascertains authorization of document alterations, tracks each file version, and identifies all past iterations. Final records are kept read-only.

Digital Signatures
EQMS ensures administrators complete visibility adding full control over all e-signatures across the system. They can autonomously create and cancel signature requests setting the locations they can be used to protect and prevent fraudulent activities.

21 CFR Part 11 mandates all system users are trained prior to all task assignments and projects. An EQMS can regulate all requirement conditions via signing in the system by responsibility documentation as a training module.

Parting Thoughts

The 21 CFR Part 11 critical mandate for research teams working in regulated environments serves a valid purpose.

As the requirements of 21 CFR Part 11 not only ensure the authenticity, integrity, and confidentiality of all captured raw electronic data, but also the non-repudiates digital electronic signatures. It is solely the researcher’s responsibility to ensure all instruments and software deployed for data collection and analysis are validated to meet the 21 CFR 11 guidelines fully.

About Thought Frameworks

Thought Frameworks is a U.S. based QA and software testing organization that’s been leading in business since 2009, armed with the ultimate solutions for all your software’s QA testing challenges. Having headquarters both in California, USA and a fully functional well equipped QA Test Lab in Bengaluru-India, that delivers premium QA and QC services endlessly across different Industry domains and niches. An ISTQB Silver Partnered Company, our superhuman test team heroes have delivered numerous successful QA and QC projects for clients across the globe. Get powered by our deep dive bug hunting process that helps your software in clocking release cycles on time while delivering excelling quality and functionality.

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