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20 April 2015

Follow The Five C’s for Successful Document Management

By Claire McCluskie

Gaining control of documentation is crucial for an organisation as it strives towards operational success.

Within the healthcare and life science industries, a typical organisation will create numerous types of documentation daily: from SOPs and work instructions to regulatory guidelines and polices. These documents can be used to convey new ideas, provide direction, give instructions, describe processes, define specifications and serve a host of other purposes.

Yet, often the documents being generated are done so in an ad-hoc environment, without much thought as to how they will eventually be used or by whom, and then stored in various locations. This can create chaos and confusion which can have detrimental effects on the welfare of the organisation.

By learning to crawl before you can walk, you are setting yourself up for future success by mastering the most basic of tasks. Organisationally, gaining control of your documentation is a key step towards future operational excellence.

Laying the foundations to success…

Document control is the foundation of any successful organisation, and yet many are still getting it wrong.

It’s imperative you gain control of your (no doubt) vast volumes of documentation if you are to maintain high levels of performance and ensure your reputation, and indeed business, remain intact. After all, there’s nothing worse than receiving adverse customer or regulatory observations due to document reviews, approvals and distributions being delayed by a manual and laborious way of working.

The ‘Five C’s for Successful Document Management’ can provide you and your organisation with a framework for complete document control.

So what are the five C’s?

  • Control
  • Compliance
  • Credibility
  • Competence
  • Confidence

Control

 An effective way of achieving document control and successful document management is by adopting an electronic software solution. By having your paper system replicated by a software solution, you are provided with a single point of access to the correct and up-to-date document. This means staff don’t have to search for the correct revision in folders, filing cabinets or multiple databases. It also means that the lifecycle of a document can be consistently managed and controlled.

When documents change, it is important to consider the ripple effect this will cause across the business and also when looking outside the business, to customers and suppliers. By being able to manage documentation in one central place, it means you have greater control, with approvals and reviews carried out quickly which reduces the chance of operational processes being delayed and customer observations.

By gaining control over document versions and access, management and auditors have peace of mind that staff are using the correct revision of a SOP and/or other process, with automated workflows being followed. This leaves senior management safe in the knowledge that data integrity remains intact, as the correct people can access the document (whether it be a SOP, work instruction or a contract) when they need to, and that the correct people are able to manage the document life cycle.

 Compliance

By having strict document management and document control in place, it eases compliance burdens as well as appeasing regulatory bodies. For example, if the MHRA audits a life science organisation against GMP requirements, they can review the status of an organisations controlled documents in seconds via an electronic document register. The appropriate distribution and electronic acknowledgement of documents from the register is similarly transparent to the regulatory inspector. This can reduce the time spent preparing for the inspection, as well as the inspection itself, as there is less effort involved for all stakeholders, including the MHRA inspectors. Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements.

In addition, a robust document management system will also have further benefits for your compliance requirements. New commercial markets can become available by meeting the requirements of global regulatory bodies such as the FDA. 

Credibility

Achieving and maintaining compliance can only enhance your organisation’s credibility. This is a huge factor as a strong reputation among clients and within the industry is crucial. By proving you are in control of your documentation and processes to relevant stakeholders, you quickly strengthen your credibility and continue to do so by meeting management, customer and industry demands.


Competence

In the healthcare and life science industries, point of access and version control are hugely important. For example, you don’t want to be following an out-of-date procedure if you’re working on a clinical trial or testing API’s or finished products. Through achieving successful document management and control, you can be rest assured that your staff and colleagues always have easy access to the correct and up-to-date version of a document exactly when it is required.

By having your documentation stored and managed centrally in an electronic system, it means if there is a change to a SOP or a legislation you’re made aware of it and can be properly equipped with knowledge of the change to remain competent.  

Confidence

By achieving the above, you naturally increase confidence in your organisation: from customers, staff, auditors and the industry itself.  Due to an effective document management system being in place, the risk of observations or issues being raised is reduced and the business is robust enough to stand up to external and internal audits.

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