Regulatory
Ensure FDA and EU MDR regulatory compliance
Get practical support for immediate compliance requirements and to resolve pressing regulatory challenges. We also offer expert regulatory consultancy solutions that will optimise your pharmaceutical facility’s compliance processes and procedures, making them more efficient and effective while reducing risks.
Regulatory Expertise
Our regulatory experience and expertise will help your organisation achieve and maintain compliance as well as making compliance processes more cost-effective and efficient. Our engineers and regulatory specialists have expertise working with organisations of all sizes, with that expertise covering the laboratory, manufacturing, and QA (quality assurance) functions of pharmaceutical facilities.
We also have extensive technical expertise that we will use to modernise, optimise, and improve all aspects of compliance in your organisation.
Tailored Regulatory Support
Our tailored regulatory support solutions will help you maintain compliance with FDA regulations, EU MDR, and regulations in other jurisdictions. We can provide end-to-end regulatory support services, compliance-specific technical support, or support that augments your existing quality and regulatory team.
Ensuring computer systems are compliant, utilising technologies to automate compliance processes, and improving data accuracy, integrity, and availability are just some of the ways our team can provide regulatory support.
Tailored Compliance Support
- Reviewing, creating, and updating policies, processes, and SOPs (standard operating procedures) across both manufacturing and laboratory environments.
- Identifying and mitigating compliance risks.
- Lab informatics solutions that, among other operational and productivity benefits, help improve the audit readiness of your laboratory.
- Integrating manufacturing, laboratory, and IT systems to improve data collection, transmission, storage, reporting, and accessibility.
- Enhancing both laboratory and manufacturing system controls to improve data integrity and security.
- Consultancy services and compliance reviews to assess current compliance processes, technologies, and capabilities.
- Compliance technology implementations and upgrades.
Discuss Your Requirements
Regulations, Standards, and Best Practices
- FDA, EU MDR, and OUS (outside the United States) regulatory requirements.
- 21 CFR Part 11, the FDA’s regulations on electronic records and signatures.
- EU MDR Annex 11, the EU’s regulatory guidelines on using computerised systems.
- GAMP5, the best practice framework to ensure computerised systems are compliant, fit for purpose, and effective.
- GxP, the quality guidelines and best practices that include GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice).
- CSV (computer system validation) and CSA (computer software assurance), the guidelines and processes for validating computer systems.
- ALCOA+, the principles that ensure data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Regulatory FAQs
What are the main best practices for regulatory compliance in pharma?
There are four main pillars of compliance that influence our delivery of regulatory solutions, services, and support:
- Knowledge - we stay up-to-date with the latest developements in regulations, guidelines, and best practices.
- Record-keeping and documentation - we implement robust controls, policies, and procedures for documentation and record-keeping.
- Risk management - we identify compliance risks and put in place strategies to manage and mitigate those risks.
- Quality control - we ensure there is an over-arching focus on quality as quality is the cornerstone of compliance.
How does technology and automation improve pharmaceutical laboratory compliance?
There are a number of tasks performed by laboratory teams that can be categorised as non-scientific and/or non-laboratory work. Data collection and recording are two examples, in addition to ensuring data integrity. Performing these tasks manually takes up valuable time and resources, and creates significant scope for human error. Technologies and automation solutions free up resources for laboratory and scientific tasks while optimising compliance processes and eliminating the risk of human error.
What are data integrity controls in the pharmaceutical industry?
Data integrity controls are about ensuring your organisation's data is accurate, consistent, and reliable, and they are essential for regulatory compliance. Following ALCOA+ principles is an effective approach to implementing data integrity controls. In ALCOA+, data should be:
- Attributable - the source of the data and the date and time should be recorded
- Legible - able to clearly read and understand the data
- Contemporaneous - data is recorded at the time an action takes place
- Original - data records should not be transcriptions or copies
- Accurate - data should reflect what happened and be free from errors and editing
- Complete - nothing should be deleted, missing, or lost
- Consistent - data should be chronological
- Enduring - data should always be available in the future
- Available - data should be accessible
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