21 CFR Part 11 Compliance

Pharmaceutical Manufacturing Regulatory Compliance

But you won’t notice the science! Since the regulations were adapted to permit the use of digital systems in 1997 with electronic batch records, 503b pharmaceutical manufacturing companies have remained slow to adopt systems including Pharmaceutical Manufacturing Regulatory Compliance Software (to obtain 21 CFR Part 11 Compliance). This is due to internal issues around ensuring security of data, adherence to internal procedures and external regulatory compliance and a historically risk-averse industry preferring the approach of “why change it if it isn’t broken?” So perhaps Recipe Management Software is worth a second look?

These reasons have also led to a shortage of new Recipe Management Software providers entering the market as it was seen as “too hard” to prove they could offer a viable alternative…until now.

pharmaceutical regulatory compliance for electronic batch records

Pharmaceutical Manufacturing Regulatory Compliance Software solution providers initially rushed at the opportunity to get into the pharmaceutical sector, but many did not combine process step simplicity with ease of compliance or a link to the end user ERP system. Customers still find today that many Recipe Management Software solutions on the market are “good at one thing, but not all”. SG Systems’ pedigree in Formulation Systems linked to customer ERP’s means they have been there and done it, with many satisfied customers across the globe.

It has been integrated to over 30 Enterprise Resource Planning (ERP) & Accounting software applications, ensuring a seamless link between high level company data management and what is actually happening on the factory floor.

Electronic Batch Record

The Digital Batch Record (EBR) enable operations to become more dynamic as information is available for checks or audits with just a few mouse clicks. The ‘e-review’ is much more efficient compared with review of paper only or hybrid records.

SG Systems Global has worked with a pharmaceutical industry leading expert to ensure their Recipe Management Software solution meets Pharmaceutical Manufacturing Regulatory Compliance Software and best practice.

503b batch weighing, pharmaceutical regulatory compliance electronic batch record with recipe management software 21 CFR Part 11

V5 Traceability is technically compliant with 21 CFR Part 11 (view assessment) and SG Systems Global is ready to work with customers to ensure that customer internal processes are aligned, in-order to obtain full compliance with the regulation.

SG Systems Global approach to the customer experience is that the “science” that enables their system to perform complex data management and process control tasks stays in the background. The priority is on the user-interface being intuitive, easy to use and also privilege based, so you can only do what you are allowed to do – all of which means you can conduct your business effortlessly, whilst being sure that all the important data is being recorded for compliance.

Why Go Digital with Manufacturing Traceability?

Improve Manufacturing and Lead Times

V5 Traceability offers simple yet clever EBRs which speeds up the production time and reduces delivery lead time to your customers.

Quality Assurance (QA) teams can use V5’s EBR’s “review-by-exception” functionality to see deviations more quickly than looking at every single record. This significantly reduces documentation review times and helps to ensure product can be released as soon as it is moved from production into the warehouse.

Pharmaceutical Manufacturing Regulatory Compliance Software Recipe Management Software 21 CFR Part 11

Batch accuracy and consistency is also improved thanks to the clarity and availability of real-time event data.

Production processes and warehouse management (stock movements) are managed effectively, also in real-time, which further reduces task time from paper based or standalone process management systems.

Recipe Management Software for Reduced Manufacturing Costs

With time savings come cost savings. The V5 Traceability solution ensures effortless digital compliance, reducing time previously spent on paper-based systems and multiple cross-checking and verification stages.

V5 Traceability guides the operators and supervisors through the manufacturing and validation process, with simple “go/no-go” on screen instructions, with QA questions asked at management defined steps, meaning compliance is achieved as part of the process, instead of as a mopping up exercise afterwards.

Electronic GMP Good Manufacturing Practice Software Recipe Management Software

Avoid Bad Data – Eliminate Transcription Errors

V5 Recipe Management Software reduces human error because the instructions are visible on-screen and data entry is typically via drop down selections or, in the case of ingredient type, finished batches and lot number selection, scanned in via a barcode scanner.

This minimal human interaction with V5 Traceability ensures rapid release of product as any issues are apparent at the moment they occur.

Pharmaceutical Regulatory Compliance

Whichever way you turn, there is no “avoidance” scheme in the 503b batch weighing pharmaceutical sector. Thankfully V5 Traceability brings all the checks required and various sign off stages into the digital era, so compliance is effortless. No-one can drop the ball, so you can be confident that there will be no nasty surprises from consumers or from the auditor!

Pharmaceutical Manufacturing Regulatory Compliance Software Electronic Batch Record for Digital Sign Batch Off Recipe Management Software 21 CFR Part 11 503b batch weighing

The same procedures that are there to ensure compliance also mean your own product is consistent by default, meaning even more satisfied customers. In the same way, serialization is also obtained, another massive win in the goal to achieve “paperless” with all data compliant requirements leading to a fully electronic batch record within the Recipe Management Software.

Compliance with ALCOA+ Criteria for Data Integrity

V5 Pharmaceutical Manufacturing Regulatory Compliance Software complies with the original five criteria used for data integrity based on the acronym ALCOA that was developed in the 1980s by an FDA inspector and also with the expanded ALCOA+ from 2010. See the nine-point criteria listed below:

• Attributable Identification of the individual who performed an activity and the date that they performed. Time is also applicable with a computerized system and time zone if a system spans time zones.
• Legible Can you read and understand the electronic data together with any associated metadata or all written entries on paper? Legible should also extend to any original data that has been changed or modified by an authorized individual so that the original entry is not obscured.
• Contemporaneous Documented (on paper or electronically) at the time of an activity.
• Original A written observation or printout, or a certified or verified copy thereof, or an electronic record including all metadata of an activity.
• Accurate No errors in the original observation(s) and no editing without documented amendments / audit trail entries by authorized personnel. Any instrumentation used is qualified and calibrated within acceptance criteria.
• Complete All data from an analysis including any data generated before a problem is observed, data generated after repeating part or all of the work or reanalysis performed. For hybrid systems, the paper output must be linked to the underlying electronic records used to produce it.
• Consistent All elements of the GMP record such as the sequence of events are consistent and do not contradict each other. Entries are date (all processes) and time (sometimes paper records and all using a hybrid or electronic systems) stamped in the expected order.
• Enduring Recorded on Authorized media e.g. numbered worksheets for which there is accountability or electronic media that can last throughout the record retention period.
• Available The complete collection of records can be accessed or retrieved for review and audit or inspection over the lifetime of the record.

Smooth integration via Gateway link or API

V5 Recipe Management Software combined with our easy to use hyperlinked EBRs drastically reduce complexity in the manufacturing and compliance processes.

V5 Traceability uses a simple Gateway file exchange or an API (SG Systems Gateway Link) to join up shop floor events with back office management.

When integrated to a customer ERP, the time savings are considerable, giving access to critical information from the factory or warehouse, anywhere, anytime.

Electronic Recipe Formulation System

V5 Pharmaceutical Manufacturing Regulatory Compliance Software controls access rights and privileges with the option to link to client security protocols via Single Sign On (SSO) – all compliant with 21 CFR Part 11 providing electronic batch records.

Formulation versions are electronically controlled so only approved formulations are released to production, further preventing errors and costly scrap batches.

There is no opportunity to input incorrect data, giving the individual operators and their management confidence that all steps have been completed accurately.

Go/No-go Batch Weighing ensures consistent batches are produced and that they are compliant.

Batch Review & Approval Process

V5 Traceability EBR uses electronic signatures (under SSO if required) to acknowledge and verify batch and system compliance information at the location of the transaction, saving time and removing risks associated with paper-based systems which can get damaged or lost in between production and sign off locations.

LIMS System Laboratory Information Management System Pharmaceutical 21 CFR Part 11 503b batch weighing

In summary, digital process control and compliance with V5 Traceability will:

  • Eliminate paper forms, reducing the Time to Market of your product
  • Increase production output
  • Electronic batch records
  • Ensure Product consistency, meaning less scrap batches and greater customer satisfaction
  • Comply with 21 CFR Part 11 “invisibly”, giving confidence to company management and auditors
  • Improve profit through time and cost savings


• Dr. Bob McDowall – Director of R.D.McDowall Limited (1998 – date) specializing in corporate computer systems validation and 21 CFR Part 11 policies, data integrity, analytical equipment qualification and validation of GMP, GLP and GCP computerized systems. Audits of laboratories, computerized systems and software suppliers.
• Darren Fisher – Director of Fisher Consultancy Services Ltd. 15 years working with formulation and traceability systems across various manufacturing industries with multiple industry leading OEM’s.