Creating Websites

Consumers can get basic accessibility to the Cloud server and set up the Apache web server onto it and then deploy PHP if required. Users can additionally include Load Balancing along with Failover features to the site. Users can reduce expense of marketing and client facing infrastructure with the help of Cloud Servers.

Sustaining Databases

A Cloud Server might be used like a database server. A consumer could install MSSQL, PostgreSQL, MySQL or for that subject any database which works on the backed operating systems. A Cloud server can however work as the main or supplementary database.

Receiving and Sending E-mail

A Cloud Server works extremely well as an e-mail server or e-mail client.

Developing and Screening Application

Cloud servers can reduce the price of development and evaluation of new programs. Development servers could be provisioned quickly and utilised only for the timeframe that they are required. This minimises hardware procurement time frame as well as funding expenses. Consumers can also limit the time for set up and split down of screening environments making use of the Cloud Servers API.

Coordinate Multiple Sites

Customers can deal with multiple websites and domains on particular Cloud Servers by applying name-based exclusive hosting.

High End Processing

High end processing needs enormous compute power. However the computed tasks may not keep the computers hectic continuously. Using Cloud Servers, customers can reduce costs by acquiring compute power only if they want it and sending back to Cloud Server when it is not needed.

Suggested Additional Reading

Benefits of Proceduralised Systems
The Power of Word Processing and Typing Skills

Author:

Umair Khan

The major release often initiates new functions or capabilities. It may accumulate all the various changes from early minor releases. The minor releases integrate a couple of fixes for identified problems into a trusted state or baseline of an item. Emergency releases on the other hand are quick fixes to mend unanticipated problems or momentary measures to avoid the disruption of vital services.

Three Types of Release

There are also three kinds of releases that reflect diverse ways of arranging and packaging changes to software or hardware CIs together. These are full release, delta release, and package release. Full release incorporates all the elements of a software or hardware CI, including those that have not been changed. Delta release incorporates all the elements of a software or hardware CI which have changed. Package release on the other hand spins the changes to different CIs into one release.

There are five major steps that are entailed in the process of release management and these are building and configure which entails the assembling of the component of release in a restricted laboratory setting. Test and accept which is done prior to distribution. Here testing by neutral group occurs. The testers can be users, IT staff, or business staff. The main purpose of testing is to validate the release using different methods. The third is schedule and plan which explain rollout of the release. Next is communicating and preparing which involves the preparation of the rollout plan. And lastly, there is the distribution and installation of the software and hardware. All these steps are followed for effective release management.

Suggested Additional Reading

Benefits of Proceduralised Systems
An Easy Way to Validate an SQL Report
The Power of Word Processing and Typing Skills

Author:

Henry Oswaldson

Regulatory

Firstly, in this context a regulatory audit is one that will be performed by the MHRA/FDA or other national body on the application of legislative requirements within a pharmaceutical company.  For example for the application of GMPs.  It is usually the case whereby the regualtory body will inform the company of their intented visit and then arrive to site and conduct their audit in accordance with their predefined requirements.

Do they only look at what they originally said?  No, they don’t – it is not uncommon for them to have a look at something that is brought to their attention or at something of interest within their peripheral vision, for example when inspecting a change log, they might ask to see an additional change control that is of interest to them, or another item or items that are referenced from the change log.  In order to prevent citation, or at least minimise it, make sure that your controls are robust.  Make sure the quality system is being used properly, and the procedures are current and that they work!  If you aren’t sure, get help!

Supplier

Supplier audits are carried out by companies to ensure that they can supply a consistently fit-for-purpose product/service at all times.  The crux of these supplier audits is basically an assessment of the suppliers’ quality systems; for example if you are going to buy in a control system, it is obviously an intented long-term investment, that being the case there will be an ongoing level of support required from the vendor, and likewise this is going to yield a support agreement between the two companies whereby the supplier is making money from the pharmaceutical company and the pharmaceutical company is making money from the control system.

The pharmaceutical company has to be sure that when they are receiving products (upgrades, updates, changes, hotfixes and all of that stuff) from the vendor (supplier) that they have adequately controlled the release of that product.  This can be determined by performing an audit of the suppliers quality system.  For example, if the supplier has a set of perfect procedures encompassing change / configuration and release management, and a bells-and-whistles document management system, they should be fine.  But on inspection, if there has never been a change entered into the change log for 6 months after the procedure’s effective date – this raises questions about whether they do, truly have a full and complete understanding of their own systems, because one thing is for sure, things change and if they don’t have documented changes then their documentation can’t reflect the system.  How might that affect your control system?

Summary

Regulatory audits are performed by legislators, supplier audits are performed by potential clients.  The client needs peace of mind that you’re going to do everything in your power to control and regulate your products and services in order for them to be able to produce fit-for-purpose, consistent products themselves.  If your potential client finds that everything is too perfect and no mistakes have been made -ever, then they’ll probably suspect some sort of mistake; everyone makes them!  The outcome of the supplier audit is whether or not you win the work.

Regualtory audits are verifiying conformance to the governing legistation.  If they observe any serious non-conformances they have the power to have you shut-down (not that this happens very often, but nevertheless they have the power) or stop you from trading.  So it pays to comply.  If in doubt.  Seek professional assistance.

Suggested Additional Reading

Benefits of Proceduralised Systems
An Easy Way to Validate an SQL Report
The Power of Word Processing and Typing Skills

Author:

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A small group of computer system validation specialists were working on a client project to help validate a legacy computer system in response to a regulatory citation.  On arrival to the site and during the elicitation of the user requirements (required as part of the validation package) it was identified that there was no formal document or change management processes within the IT department.

This is a serious finding as without controlling changes and documentation – there is effectively no control within the area.  There were some basic documentation and change management procedures approved and effective for the site, however the approved scope was grey with regards to computerised systems.

It was obvious to the team from the very start that trying to validate computer systems without a formal document or change control process was going to be firstly, very difficult and secondly a non-compliance in itself in accordance with applicable industry regulations and good practices.

Two options preceded the group:

1)      Revise the existing site change and document management procedure to fully include the scope of information systems and IT, then use these procedures and processes during the course of the project.

2)      Implement a project document and change control function that will satisfy all regulatory and good practice requirements without the overhead of involving the whole site when it isn’t necessary.

This Presented Two Potential Problems:

1)      A time delay in the revision of the site documentation to facilitate the IT section of the business.  Due to the amount of potential signatories, a political overhead may also appear and this could take up to 1 month to move from a draft document to an approved for use version of the document.  There would also be an element of re-training and a delay in the ability to move quickly, especially with changes in the project environment.

2)      A resistance to change that would impact the design and implementation of the project document and change control functions.  This would still require a reference to the project methodology in the site documentation and change management procedures in order to satisfy traceability requirements (unless QA would allow the Validation Plan only to mention this process, which of would fuel further debate).  Upon implementation, users of the procedures would still have to be trained.

Bedding-In

In either case, a bedding-in period would be required during which usage of the new system would be potentially slower than usual, however the users would get up to speed quickly as projects invariably see lots of changes which causes lots of document updates.

After several discussions with the project stakeholders and IT management team, in conjunction with the quality group, we identified that there were several more IT projects on the roadmap which were a combination of prospective and retrospective validation projects.

Based on this information, it was decided that we should opt for project change and document control systems in order to facilitate a high volume of change and document updates whilst minimising external department involvement as far as possible (of course, major changes such as those that posed a risk to other systems or product manufacturing were still required to go to the site for review and approval).

Approach

We believed this to be the best approach as once the system was implemented, it meant that the client company had an effective system to use in the future, thus ensuring that all project activities were carried out in a controlled fashion whist at the same time providing a mechanism for the system to fall under the full site control once the project had ended and the system was returned to operational ownership.

DMR (UK) Limited were commissioned to implement this new system in accordance with the existing company policies and document framework and this required input from IT and Quality Assurance personnel.

This had immediately caused our project scope to creep and even though the client company had no problem in the additional cost of this specialist work, they were still insistent on the actual initial scope of the project being delivered within the initial pre-agreed timelines.

Our business is focused on the actual outsourcing of specialist documentation so that we can perform our duties from our own offices and use technology to communicate – the only usual exception is when we sometimes deploy 1 or more specialists to a client site for finite period to either help with or conduct some approved test scripts.

In this situation, we sent two specialists to the client site to expedite the new document creation.  The resistance to the change in the first place was obvious and as a consequence, our business analyst decided to select the two most resistant members of the client team to work with the new document and change control process.  This was a very strategic movement because when the change resistant customers were actually involved with the planning and implementation of these new project documents, it quickly became clear to them that what was actually going on was really important.

Furthermore, they used their internal knowledge of the site to help drive the changes through quickly as they knew all of the relevant external departmental reviewers and approvers.  We also realised that during this exercise, the change resistant customers were resistant to the change, not to be obstructive but because they didn’t understand the criticality or value of formally controlling such changes to systems, processes and their associated documentation.  This was because they had often heard of various terms, such as validation and change control, however they weren’t actually sure what these terms involved or how it was applicable to their shop-floor environment.

Valuable Lessons

Our team gave a brief overview of the systems lifecycle and the reasons why the initial project had been started in the first place and once they understood that, they were more than happy to be part of the team.  A key lesson was learned for the client:  “Don’t just expect human conformity without rationale, people are more willing to help when they know why they are doing something, not least because this gives them greater worth in both their professional positions but as humans as well”.

Lessons were learned all through the initial phase of this project.  Firstly by taking away the resistance from their usual roles and giving them a voice through educational means.   This made them happy, but more importantly, as they were part of the design and implementation of the new process, they became the key advocates for change – they now understood the requirement for changes and assisted with the implementation of the project infrastructure which had been unexpectedly put in place;  they helped train their colleagues in the use of the system and mentored them through their first few document updates and changes – this helped to bring the team up to speed quicker and fewer people tried to continue making uncontrolled changes and not bothering to update the documents.  When instances of not being sure what do arose – these people also acted as the interface between the client team and their DMR (UK) Limited counterparts, thus naturally becoming the leaders within their group.

Results

The end result was that the two specialists that were deployed were able to return back to work on the DMR (UK) Limited site one week early whilst the client project team were fully geared up to execute the initial project.  The initial project was delivered within the initial timeframe and because of the change resisters becoming advocates for change, the client saved money in the final project delivery because the quality of the documentation and clarity of the change requests was consistently in a good order, thus fewer review iterations were required.

The benefit of outsourcing as much of this type of project work as possible is that the company to whom this work is outsourced always has other work going on.  This means that rather than having specialists on the client site waiting for  the client, they are in their own office with planned work to be doing during these “lulls”, meaning that the specialists aren’t just “keeping up appearances” whilst the client isn’t paying for “lulls”.

Of course, not every situation is suited to this configuration, however a lot of situations are – in addition, this mechanism also provides for the company to be able to take on small and one-off scopes of work for companies who don’t have the resources or technical ability to deploy a large team.

This was exemplified for us further when a client (from Ireland) whose designated ISO specialist had had to go on sick leave just as the company were about to be ISO accredited subject to their imminent, final inspection; they asked us to complete two procedures for them.

This would have been must more costly if someone had to go to Ireland but once we’d agreed the terms, the work was completed in half a day by a business analyst who worked from home kindly volunteered to work late until the job was complete and thus having the work completed with that same day.  This would not have been possible is our resources were outsourced to client sites permanently.

Suggested Additional Reading

Benefits of Proceduralised Systems
An Easy Way to Validate an SQL Report
The Power of Word Processing and Typing Skills

Author:

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One Finger Typing…

To be able to avail of a word processing application, we need to type whether we are typing with 1 finger on one hand, or we are using 2 hands and typing 10 word per minute (WPM) we’re typing all the same.

So, what’s the relevance of this on a validation article? Regardless of our current job roles, we are something else firstly, for example a Validation Specialist responsible for writing specification and test case documents is required to be of a certain competence level in word processing and typing before they can validate. Why? Because without the typing and word processing there is no validation in the first place.

Typing is Power

Word processing is power, typing is velocity. In can’t recall a single day in an office environment when I have not heard colleagues asking one another for help in Microsoft Word so that something usually quite simple can be achieved in a document that is to be used as part of a formal validation lifecycle. Usually, in most cases before someone asks for help, they’ve been trying to figure out the problem themselves and have either given up due to impatience or due to external time constraints they’ve had to just find out from someone else.

So, why can’t people competently use the tools they are living with for at least half of their working days, tools they’re used daily throughout their careers? In the case of anyone under 35 years old, most people would have been using Microsoft Word since their school/college days and subsequently at university, yet the vast majority of users don’t understand even the most basic functions and control functionality of this wonderful application.

The most important basic components of a word processor are:

Format Painter
Styles
Linking (References, Cross References, TOC, Numbering)
Managing Tables

The format painter tool is probably the most powerful and useful tool in Word. This can be used to replicate styles and formatting such that consistency is maintained across a document; this helps to maintain the “look good, feel good” factor of a document.

Getting Styles Right, Time Spent Now Will Save Time in the Future

Styles are critical for supporting the scalability of a document, not only are styles such as section and paragraph number imperative in achieving and maintaining reference points, they also provide a sound basis for the interlinking of sections and cross referencing, meaning that instead of saying “See Section 5.7.2”, a link to that section can be included, this is powerful because when a new section is required above the said section 5.7.2, the link will update meaning that the document is still correct.

Manually typing such references is very dangerous and can make any document fall out of sync with it’s various subsections very, very quickly; a document that doesn’t have the correct section reference points wouldn’t inspire much confidence, so if you don’t want the quality of your validation to fall under the spotlight then make sure you don’t make mistakes; utilising and maintaining styles and availing of linking functionality will mean that these fundamental mistakes will simple not exist.

As an added bonus, word comes with a built-in document map – this is highly valuable and saves even more time when working with a large document, no more scrolling down for miles to simple past in a tag reference number. This only works properly though when the styles are used properly so be careful when starting out – once you start using document maps, you won’t revert back to the old fashioned way of working!

Learn how to use tables, we all use them – they’re important

Tables are critical, especially in validation documents because they provide a great framework for easily presenting information that is sometimes complex. Often, in order to make tables look good cells have to be merged and the tables repositioned for aesthetic purposes.

Don’t let this beat you, there are only a few things that really go wrong with tables, such as the way they try to allow text to fit around them, this is usually to do with the alignment and text wrapping properties of the table and shouldn’t be a deterrent for not using tables or for not making them look good.

One bug with Word is that to get table header rows to repeat needs to be played around with a bit in some cases, but most importantly, this always works. One pet hate of mine is that some people allow rows to break across pages, whilst this is unavoidable in some cases of large tables spanning multiple pages, it is more often than not just a case of not knowing how to stop this from happening or just a lack of regard for how the document looks, in either case I suggest that if you concentrate on making the document look professional, the knowledge of using the word processor will come naturally if you let it.

To achieve relative competency in a word processor, the first step is to learn the terminology of the application; it’s not difficult and there are millions of tutorial pages on the Internet, unlike a specialist pharmaceutical product – the whole world uses Word and therefore finding answers is incredibly simple, but one needs to know what to type into Google in order to find the answers. Once you’ve learned the terminology, there are two choices – use the Internet for help or use the built-in on-line help that is part of every MS Office application. The Microsoft Word help is extensive and easy to follow.

An Aquired Skill Well Worth It’s Salt!

Secondly, once you’ve mastered the word processor, you will have plenty of extra quality time to get on with the job. To get even more time, learn to type –again the Internet is a wealth of knowledge when it comes to learning anything and typing is no different; like learning any skill, be it painting, scuba diving or playing golf, learning to type will take a little time and it starts off slowly and can be annoying, this investment in your time will pay dividends, everyday for the rest of your life – whether at work or play, typing is a true skill for life and is a skill that will help, everyday, regardless of your job role. Combine fast accurate typing with word processing skills and then you’re going to always have the edge over your colleagues, regardless of where you work – you’ll be able to deliver quality quickly. What’s more is that learning these skills can be free and will save you hundreds, if not thousands of hours of labour over the course of the rest of your life – you can even do this training at work and get paid for it; when you’re up to speed you’ll be able to fly through your tasks without having a backlog.

It’s always the small things that people fail to pick up on – remember, even though you’re a validation specialist or an engineer, you’re a word processor operator and typist as well, so be good at using the tools of your trade and you’ll be rewarded. If you’re a manager and you have a sizable team of people using word processing software, you should consider taking some time out to train yourself and your team in the arts of typing and word processing – it’ll pay dividends – Let me know how you get on.

Suggested Additional Reading

Benefits of Proceduralised Systems
An Easy Way to Validate an SQL Report
Case Study – Project Structures DO Work!

Author:

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Qualified Infrastructure is a must for hosting any validated cGxP system; Network Qualification is a fundamental component of any Infrastructure.  Networks are complicated and not many people really know about them, but how complex are they?

To qualify a network, the first task is to perform an assessment of the network or networks on a given facility.  Usually, in the Pharmaceutical industry each site will have multiple networks:  Site Network (Enterprise LAN), Laboratory Network, Process Network, Building Management System and so on.  It’s both rare and bad practice to have all of these on the same segment for many reasons including:

• Separate Networks support the closed system requirements of FDA in the 21 CFR Part 11 ruling.
• Segmented networks provide for an overall reduction in broadcast traffic which could potentially slow down a network.
• If a virus or malware finds its way onto your network, it can be isolated much easier if everything isn’t connected on a permit any traffic to anywhere basis.

The outcome of this assessment is a system boundary document that contains a system boundary diagram.  From this document, the disparate parts of the network can be broken down and the qualification strategy derived relatively painlessly; break it into smaller, manageable chunks to make it look and feel like a simpler, less daunting task.

Intelligence

Networks consist of switches and routers as the intelligent devices that facilitate communications and  cabling (both horizontal and vertical) that joins the network devices to various workstations, servers, printers, controllers, etc.  Networks can be qualified either locally (LANs) or on a wide area basis (WANs).  The system boundary document should describe what is within the scope of the qualification and what is outside of the scope.  Often corporations like to qualify the WAN for the entire business leaving the local sites to quality the LANs.  This may not always be the case but the system boundary document should nevertheless make this clear.

Intelligent devices are VERY intelligent, the amount of processing that these pieces of kit are tasked with is phenomenal; it would be unrealistic to try and document everything so the approach is to document the main characteristics of the devices and to ensure that each piece of kit is configured and installed in a consistent fashion, e.g. everything would be configured the same except the hostname and IP address (and subnet mask and default gateway as applicable) in many cases.  If, for example a switch that had both Layer 2 and Layer 3 functionality was under qualification and routing functions weren’t required then the qualification of the Layer 2 components would only be in scope.

Behind the Walls Stuff

Cabling is the next most crucial item on the agenda, there aren’t any networks without cables – even wireless networks are wired somewhere, with a cable.  Horizontal cabling is the backbone stuff – the fibres that join building and the copper that runs from patch panels in communications room to wall outlets in offices and the factory floor.  Vertical cabling is for example the patching of servers to switches, workstations to wall outlets.

It is quite acceptable to only qualify important or critical vertical cabling, for example many companies qualify connections from servers to switches and monitor the health of these connections, however qualifying non-critical workstations doesn’t serve much purpose.  We care if a server fails, but do we want to know about 400 workstations closing down at 5pm?  Keep it to the point – if a workstation or something no so critical fails it can usually be easily replaced or a substitute is nearby.

There are an array of standards that must be followed when installing / qualifying cabling including maximum and minimum distances for optimum performance and terminations types.

When installing fibre optic networks especially, but for all networks in general it is important to consider how the diverse cable routes will flow – for example if a network between two buildings is designed to not have a single point of failure, it wouldn’t make any sense to have these buildings connected up twice with the fibre cables in the same tray under the road.  Why?  Because if a digger comes along and cuts the cable, they both get cut and there is no network.  Diverse routes should be different, thus going the other way.

Using Control as a Tool

So how is this actually qualified?  Qualification in this sense is demonstrating control of the system (the network) and showing that it is thoroughly designed and documented.  Architecture drawings should be produced for each network and it’s associated interconnections, wall outlets should be labelled clearly and non-ambiguously as should their associated patch panels.  A minimum level of testing should be carried out when installing equipment – basically, the application of due diligence serves will make the job easier.

Logical diagrams should be produced to show inter-site connections and boundaries as well as any interfaces that exist.

A lot of effort?  Not really because a well defined network qualification project’s end product will be a suite of documents and drawings that will also act as an engineering tool.  Any changes can be planned at the desk and the drawings marked up and revised as part any subsequent change control; any faults or network problems can be investigated easier as the documents and diagrams contain all information required to identify and isolate issues as well as being the starting point for initiating changes or disaster recovery as necessary.  Similarly, when expanding or upgrading parts of a network the framework exists and the planning can simply commence without worrying what is correct and what is not.

The network qualification exercise will help to create a baseline of the minimum network requirements together with a system for documenting the network, both textually and pictorially.  An approved qualification plan will allow for devices, cables, LANs, WANs, interfaces and boundaries to be listed out and tackled on a scalable basis (allowing for flexibility depending on size and complexity), monitoring can be added to the network to provide for useful statistical management information to be gathered in order to proactively determine where problems might occur and where assistance is required, similarly, when users complain that the network is slow it is possible to prove quite easily that the network is fine and that the problem is with the servers (or elsewhere).

Summary

In summary, we have identified the components of the network and discussed breaking them down into manageable chunks for the purposes of qualification and management alike.  Even though this work seems daunting, a good engineering tool is the ultimate deliverable which also serves well during regulatory inspections to prove that the platform hosting so many critical applications, systems and processes is actually qualified and verified to be fit for purpose.  Network qualification performed properly is a good job well done and ticks a lot of boxes, in addition post-qualification the network is in a healthy, manageable condition ready to be given back to the helpdesk to maintain.

Suggested Additional Reading

http://dmr-ltd.co.uk/benefits-of-proceduralised-systems

Author:

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Procedures are the documents that store these small step-by-step instructions in order to ensure that each time a task is carried out, it is done so correctly and consistently.  The more our procedures are written, stored, reviewed, updated and maintained; the better quality results our businesses would yield (and our worklives).  There is one problem:  People, for whatever reason just seem to hate paperwork – I, personally like it, but that is maybe because I can type quickly – some people just hate word processing and typing and/or computers so there is a massive resistance (especially in non-high-regulated businesses to go down this route).

I am going to raise 6 important purposes to adopting a procedural business system and explain them in the context of my experience to date:

A Written Approach to a Job or Task

Sitting in a room with X amount of colleagues and saying:  “Listen up, we have been doing A, B and C for some time now and as a result of a new computer/till/alarm system/supplier we are now going to do the task like X, Y and Z”.  If you have got 10 people in the room, you have got the potential for 10 slightly different variations on the new requirement.

So why have a procedure?  Because having a procedure allows each and every person to be able to do a specific job function in a pre-approved way.  No variations.  If someone is off work sick or on holiday – anyone can be trained (quickly) in the usage of the procedure – business continuity.

Consistently Producing the Same Results

If the procedure is found to have issues or problems, the people following the procedure can quickly identify the problem and obtain a resolution.  Without the procedure been there in the first place, there would be a risk that 10 people are performing 10 procedures and 9 of them could be wrong.  Wrong enough to cost money to the business or damage a reputation.  The procedure allows for consistency across the board and furthermore, makes the job more measurable rather than having some fast or slow; good or bad staff – a procedure allows the actual difficult and tediuous tasks to be easliy identified and allows management to assign certain roles to certain individuals with the relevant capabilities.

Mechanism for Resolving Errors and Living with Changes

In the event that an error is identified in a procedure, the procedure can be revised and released back into operations within a short space of time, meaning that the error or issue has been captured and the procedure aligned so that the business can cope in a quality assured fashion.  This creates an attention-to-detail environment and operators or users are more likely to apply due dilligence than they maybe would be without a structured framework in which to work.

Point of Reference for Communication

When describing a task to your workforce, it is easier to say that X,Y and Z in Procedure OFE-1009 should be assesed and updates recommended as a result of a new computer system installation by the end of week 34, as opposed to trying to descibe the issue you are alluding to, especially to non-technical staff.  Everyone knows what procedures are because they have already been trained in their operation (more of this later).  In addition, when multiple procedure are used (and it is strongly advised that they are) – when some tasks are required to include items from others, then the procedure can reference that operation explicitly, e.g.  Ensure all work surfaces are cleaned in accordance with OFE-1009, Section 15.0, Step 12.  Meaning that if, for example a Health & Safety Executive requirement causes an impact to your process, you only need to capture the change in the relevant location and not in every document.

Platform for Enhancing, Revising, Maintaining and Retiring Business Processes

Working with procedures, as mentioned above helps to instil a culture of due-dilligence and attention to detail.  This is imperative in a succesful business.  If people are familiar with reading, verifying and general being alert and not just ‘coasting’ by, then there is a good chance that general quality and the approach to quality assurance with also improve.  Create a culture of awareness, allow people to make changes in a structured way and communicate changes to the relevant users of the procedures.  Make sure the procedures are approved by management and some form of quality function and certainly never approved by the author (this is a conflict of interest and humans simply can’t always identify their own mistakes, typographical errors and so forth – I bet I don’t find any mistakes in this article but someone will and an email will be sent forthwith).

Training

It’s one thing having a set of procedures, but if nobody uses them properly, updates them or looks after them, then you’re pretty much in the same state as someone without any at all.  Training is about renting a conference room at the nearest 5 star hotel and sitting around the projector for 2 days, half asleep, half drunk from the night before.  When you have established your procedures, get everyone in a room and run through the procedure.  Get people to sign a training attendance form to confirm that they attended and understood and make sure they do as they agreed.  For larger, complex tasks sometimes a questionnaire of about 10 questions can be devised from the procedure to ensure everyone has took notice.  If a procedure is revised.  Make sure the new effective date allows for the users of the procedure to be informed of the changes and that all concerned parties take 10 minutes to read, understand and sign-off on their training record.  Make it clear that without been trained in a task that it should not be carried out.  After a little bit of policing this process, it will run itself.

I hope that this article has been a soft introduction to the benefits of proceduralising your operations and that, whatever the nature of your business you can benefit from these points.  If you don’t have a proceduralised set of processes or a quality system, bear it in mind.  You won’t need one if you have 2 people in your company, but as you grow, make sure at least the key elements of the business are written down and controlled.

Look out for our documentation practices articles to follow.

Author:

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Documented Query

Obviously, from a quality perspective a documented assurance that the SQL is extracting the correct information consistently must be in place or in other words the SQL must be qualified.  This is not a daunting process, this means that a test script must be assembled that utilises a documented query and that the results are verified; the supporting evidence attached to the test script, the testing can be carried out on a set of data that is not exhaustive and returning 1000s of rows of data, just something simple whose results can be confirmed to be correct and complete.

Reporting Tool

Once the SQL query has been produced to extract the required data, the SQL can be used as a data source in a reporting tool such as Crystal Reports and then the fields of data organised in a user-friendly (easy-on-the-eye).  The SQL is executed as part of the report and voila, a nice easy-to-read set of well presented data.

When writing the SQL query, ensure that the query is structured as specifically as possible – writing a query to extract too much detail (e.g SELECT * FROM tblSales) when only a specific amount is required can impose what is sometimes as substantial strain on the system being queried, if this is a production system then the outcome can be disastrous.

Filters

In addition, reporting tools offer allsorts of various forms of filtering and sorting data – be careful not to leave filters in place in the reporting tool – this can cause the correct results to look truncated however this is something that would be usually be detected by whoever generates the report.

If these reports are to be used on an on-going basis, it makes sense to have a controlling SOP for the process of generating the reports – this is also highly recommended when dealing with cGMP systems.

Summary

In summary, SQL is an ideal data source for report tools to create many time-saving, valuable reports.  Care should be taken not to place an unnecessary load on a production system.  A controlling SOP should be in place to instruct the user on the initialisation and execution of the report in order to eliminate any user applied filters that are left over from the previous run of the report.

Suggested Additional Reading

Benefits of Proceduralised Systems
Documenting a Network Infrastructure
The Power of Word Processing and Typing Skills

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